Research & Innovation

Breast Clinical Trials

Clinical Trials

Agendia FLEX

MammaPrint, BluePrint, and Full-genome Data Linked with Clinical Data to Evaluate New Gene EXpression Profiles: An Adaptable Registry (FLEX)

Physician & Study Coordinator

Physician

Lee Riley, MD

Lee Riley, MD

Study Coordinator

Lauren Downing, BS
484-526-7936

Lauren.downing@sluhn.org

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Synopsis

Treatment Agent: N/A

Synopsis: You have been asked to consider taking part in this registry because you are being treated for stage I, stage II,or stage III breast cancer. If you participate, your doctor will receive the results of the Agendia Breast Cancer Suite (MammaPrint and BluePrint). 

The purpose of this registry is to create a large-scale, population-based database. This database will match health information to genome information to look at the Agendia Breast Cancer suite and new gene associations. The Agendia Breast Cancer Suite includes MammaPrint® and BluePrint™, which are tests that help your doctor analyze and profile your breast cancer tumor. DiscoverPrint is for research purposes only and the results will not be made available for use in your current breast cancer management.

  • MammaPrint, an FDA cleared test, is used clinically to determine your risk for distant metastasis.
  • BluePrint provides physicians with more information about their patient’s unique tumor biology.
  • DiscoverPrint will allow the study of new gene associations and additional biomarkers that may be found to be relevant to breast cancer therapy and diagnosis.
  • Breast cancer with different biological properties may respond different to certain therapies.

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Inclusion Criteria
  • Stage I-III patients with a MammaPrint and BluePrint result (male or female)
  • Informed consent form signed on the same day or before enrollment
  • Eligible to receive chemotherapy and endocrine therapy as defined by a good Karnofsky index (≥80)

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Exclusion Criteria
  • Tumor sample shipped to Agendia with ≤ 30% tumor cells or that fails QA or QC criteria
  • Metastatic disease

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Alliance A011502

A Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial

Physician & Study Coordinator

Study Coordinator

Lauren Downing, BS
484-526-7936

Lauren.downing@sluhn.org

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Synopsis

Treatment Agent: Radiation Therapy

Synopsis: The purpose of this study is to compare any good and bad effects of using aspirin after someone has completed the usual chemotherapy, surgery and/or radiation therapy for breast cancer. Some studies have suggested that aspirin may lower the risk of breast cancer coming back, but others have not, so we do not know if aspirin will help decrease breast cancer recurrence. This study will evaluate whether patients taking aspirin once per day will have a lower rate of cancer recurrence than patients taking a placebo.

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Inclusion Criteria
  • Histologic documentation of women or men with node positive, HER2 negative, anatomic stage II or III breast carcinoma and high risk node negative (defined as estrogen receptor [ER] and progesterone receptor [PR] negative and tumor size > 2 cm) within one year of diagnosis and free of recurrence; patients with pN1mic are eligible; if neoadjuvant therapy was received, either initial clinical stage (determined by physical and or radiologic examination) or post-operative pathologic stage can be used for eligibility purposes, with the higher stage determining eligibility; histologic documentation of node positivity is required; bilateral breast cancers are allowed, as long as both cancers are HER2 negative and at least one of the cancers meets eligibility
    • Any ER/progesterone receptor (PgR) status allowed
    • Prior adjuvant treatment with chemotherapy and/or endocrine therapy, as determined by the treating physician, is allowed; the last dose of chemotherapy or radiation therapy must be at least 30 days prior to study registration; concurrent hormonal therapy will be allowed
    • Regular nonsteroidal anti-inflammatory drug (NSAID)/aspirin use at any dose (including baby aspirin) (defined as >= 5 days per week) is allowed if aspirin and/or NSAIDs are stopped for 30 days prior to study entry and throughout the study period; participants will be encouraged to use acetaminophen for minor pain and fever
    • Patients must be enrolled within 1 year after diagnosis
    • Eastern Cooperative Oncology Group (ECOG) performance status 0-2
    • Patients with a prior history of gastric/duodenal ulcers documented on endoscopy can be enrolled as long as the ulcers did not cause bleeding requiring a blood transfusion/major intervention; for patients who are Helicobacter pylori positive, a course of Helicobacter pylori eradication treatment must have been completed
    • No history of gastrointestinal bleeding (GI) bleeding requiring a blood transfusion, endoscopic or operative intervention
    • No history of any prior stroke (hemorrhagic or ischemic)
    • No concurrent anticoagulation with warfarin or heparin/heparin analogues, clopidogrel, oral direct thrombin inhibitors, or direct factor XA inhibitors
    • No history of atrial fibrillation or myocardial infarction
    • No history of grade 4 hypertension, defined as hypertension resulting in life-threatening consequences (e.g., malignant hypertension, transient or permanent neurologic deficit, hypertensive crisis)
    • No chronic (duration > 30 days) daily use of oral steroids
    • No known allergy to aspirin
    • No prior malignancy of any type (including ductal breast carcinoma in situ [DCIS]) within the past 5 years except for current diagnosis of breast cancer, and any prior diagnosis of basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix; patients with a prior history of breast cancer greater than 5 years from study screening may participate in this study
    • Concurrent enrollment on a non-chemotherapy treatment trial will be allowed, as long as that trial allows concurrent daily aspirin use

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Alliance A221505

Phase III Randomized Trial of Hypofractionated Post Mastectomy Radiation with Breast Reconstruction

Physician & Study Coordinator

Study Coordinator

Lauren Downing, BS
484-526-7936

Lauren.downing@sluhn.org

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Synopsis

Treatment Agent: Radiation

Synopsis: The main purpose of this clinical trial is to determine whether a short-course radiation therapy option (3 to 4 weeks) after mastectomy is as safe and effective in the setting of breast reconstruction as the usual 5 to 6 week treatment course. Short-course radiation therapy is also called hypo fractionated radiation. This study will also examine whether a shorter course of radiation therapy will lower treatment costs and improve patient satisfaction.

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Inclusion Criteria
  • Histologically confirmed invasive carcinoma of the breast of any of the following histologies (ductal, lobular, mammary, medullary, or tubular); in-situ disease alone is not allowed
  • Final American Joint Committee on Cancer (AJCC) stage IIa - IIIa (pathologic stage T0N1a-2a, T1N1a-2a, T2N1a-2a, T3N0-2a, all M0 status); pathological stage for all patients not receiving neoadjuvant chemotherapy; higher of the clinical or pathological T and N stage, if receiving neoadjuvant chemotherapy; patients with pathological N0 at the time of mastectomy are only eligible if biopsy-proven clinically N1 or N2 disease is documented prior to induction chemotherapy
  • No prior radiation therapy to the chest, neck or axilla
  • No prior history of ipsilateral breast cancer (invasive disease or ductal breast carcinoma in situ [DCIS]); lobular carcinoma in situ (LCIS) and benign breast disease is allowed
  • No history of prior or concurrent contralateral invasive breast cancer; benign breast disease, LCIS or DCIS of contralateral breast is allowed
  • No active collagen vascular diseases, such as: systemic lupus erythematous, scleroderma, or dermatomyositis
  • Negative inked histologic margins from mastectomy pathology (no invasive cells at margin)
  • No significant post mastectomy complications requiring an unplanned re-operation or admission for intravenous (IV) antibiotics; re-operation for margins evaluation, nodal completion and routine reconstruction is acceptable
  • Radiation oncologist intends to treat all target volumes and respect all normal tissues in accordance with the dosimetric constraints described (simulation before registration recommended)
  • Radiation oncologist is planning to treat regional lymph nodes including internal mammary nodes and meet acceptable protocol dosimetric requirements
  • Radiation oncologist is NOT planning to utilize a chest wall/scar boost
  • Patient must have undergone immediate reconstruction at the time of mastectomy or be planning to undergo reconstruction within 8 months after radiation
  • For patients with diabetes, hemoglobin A1C test must have been performed =< 90 days prior to registration
  • No co-existing medical conditions with life expectancy < 5 years
  • No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix
  • Negative serum or urine beta-human chorionic gonadotropin (HCG) in women of child-bearing potential =< 7 days prior to registration; a female of childbearing potential is a sexually mature female who has not undergone a hysterectomy or bilateral oophorectomy and has not been naturally postmenopausal for at least 12 consecutive months
  • Women of child-bearing potential must agree to utilize a form of birth control or agree to undergo sexual abstinence during radiation therapy
  • Eastern Cooperative Oncology Group (ECOG) (Zubrod) performance status 0-1

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ECOG EA1131

A Randomized Phase III Post-Operative Trial of Platinum Based Chemotherapy Vs. Observation in Patients with Residual Triple-Negative Basal-Like Breast Cancer Following Neoadjuvant Chemotherapy

Physician & Study Coordinator

Study Coordinator

Lauren Downing, BS
484-526-7936

Lauren.downing@sluhn.org

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Synopsis

Treatment Agent: Carboplatin; Cisplatin

Synopsis: This randomized phase III trial studies how well cisplatin or carboplatin (platinum based chemotherapy) works compared to observation in treating patients with remaining (residual) basal-like triple-negative breast cancer following chemotherapy after surgery (neoadjuvant). Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. It is not yet known whether cisplatin or carboplatin is more effective than observation in treating patients with residual triple negative basal-like breast cancer.

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Inclusion Criteria
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 within 2 weeks prior to screening
  • Female and male patients must have histologically confirmed triple negative (estrogen receptor negative [ER-]/progesterone receptor negative [PR-]/human epidermal growth factor receptor-2 negative [HER2-]) invasive breast cancer, clinical stage II-III at diagnosis (American Joint Committee on Cancer [AJCC] 7th edition) based on initial evaluation by clinical examination and/or breast imaging
    • ER- and PR- should meet one of the following criteria:
      • =< 10%="" cells="" stain="" positive,="" with="" weak="" intensity="" score="" (allred="" score="" />
      • =< 1%="" cells="" stain="" positive,="" with="" weak="" or="" intermediate="" intensity="" score="" (allred="" score="" />
    • HER2 negative (not eligible for anti-HER2 therapy) will be defined as:
      • Immunohistochemistry (IHC) 0, 1+ without in situ hybridization (ISH) HER2/neu chromosome 17 ratio OR
      • IHC 2+ and ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6="" signals/cells="" />
      • ISH HER2/neu chromosome 17 ratio non-amplified with ratio less than 2.0 and if reported average HER2 copy number < 6="" signals/cells="" without="" />
      • NOTE: Patients that originally present with synchronous bilateral tumors are eligible provided both tumors are TNBC, and at least one of them fulfills the remainder eligibility criteria of the protocol
  • Patients must have completed neoadjuvant taxane +/- anthracycline; patients must NOT have received cisplatin or carboplatin as part of their neoadjuvant therapy regimen
    • NOTE: Patients who received preoperative therapy as part of a clinical trial may enroll
  • Must have completed definitive resection of primary tumor
    • Negative margins for both invasive and ductal carcinoma in situ (DCIS) are desirable, however patients with positive margins may enroll if the treatment team believes no further surgery is possible and patient has received radiotherapy; patients with margins positive for lobular carcinoma in situ (LCIS) are eligible
    • Either mastectomy or breast conserving surgery (including lumpectomy or partial mastectomy) is acceptable
    • Sentinel node biopsy post neoadjuvant chemotherapy (i.e. at the time of definitive surgery) is allowed; axillary dissection is encouraged in patients with lymph node involvement, but is not mandatory
  • Post neoadjuvant chemotherapy, patients must be found to have residual invasive cancer in the breast at the time of definitive surgery; residual cancer is defined as a contiguous focus of residual invasive cancer, in the breast, measuring >= 1 cm in diameter, and with more than minimal cellularity, as per local pathologist determination
    • NOTE: The presence of ductal carcinoma in situ (DCIS) without invasion does not qualify as residual invasive disease in the breast
  • Post-mastectomy radiotherapy is required for all patients with the following:
    • Primary tumor >= 5 cm (prior to neoadjuvant chemotherapy [clinically] or at the time of definitive surgery) or involvement of 4 or more lymph nodes at the time of definitive surgery
    • For patients with primary tumors < 5="" cm="" or="" with="" />< 4="" involved="" lymph="" nodes="" prior="" to="" neoadjuvant="" chemotherapy="" and="" at="" the="" time="" of="" definitive="" surgery,="" provision="" of="" post-mastectomy="" radiotherapy="" is="" at="" the="" discretion="" of="" the="" treating="" physician="" />
      • NOTE: Radiation of regional nodal basins is at the discretion of the treating radiation oncologist; patients enrolled in clinical trials addressing local therapy after neoadjuvant chemotherapy are allowed to enroll
  • Whole breast radiotherapy is required for patients who underwent breast-conserving therapy, including lumpectomy or partial mastectomy
  • Laboratory values must be obtained within 8 weeks prior to screening for protocol therapy
  • Hemoglobin (Hgb) > 9.0 g/dL
  • Platelets > 100 mm^3
  • Absolute neutrophil count (ANC) > 1500 mm^3v
  • Calculated creatinine clearance of > 50 mL/min using the Cockcroft-Gault formula
  • Bilirubin =< 1.5="" x="" uln="" upper="" limit="" of="" normal="" (except="" in="" patients="" with="" documented="" gilbert's="" disease,="" who="" must="" have="" a="" total="" bilirubin="" />< 3.0="" mg="" />
  • Aspartate aminotransferase (AST, serum glutamic oxaloacetic transaminase [SGOT]) =< 2.5="" x="" upper="" limit="" of="" normal="" />
  • Alanine aminotransferase (ALT, serum glutamate pyruvate transaminase [SGPT]) =< 2.5="" x="" />
  • No stage IV (metastatic) disease, however no specific staging studies are required in the absence of symptoms or physical exam findings that would suggest distant disease
  • No clinically significant infections as judged by the treating investigator
  • Patients with active >= Common Terminology Criteria for Adverse Events (CTCAE) version (v.) 4 grade 2 neuropathy are ineligible
  • Adjuvant chemotherapy after surgery other than that specified in this protocol is not allowed; luteinizing hormone-releasing hormone (LHRH) agonists and adjuvant bisphosphonate use is allowed
  • Patients must have archived formalin-fixed paraffin-embedded (FFPE) tumor tissue specimen from the residual disease on the definitive surgical specimen available for PAM50 analysis to determine patient eligibility
    • Tumor tissue specimen from the definitive surgery has been collected and is ready to ship to the ECOG-American College of Radiology Imaging Network (ACRIN) Central Biorepository and Pathology Facility (CBPF) within 12 weeks post-surgery
    • The Molecular Diagnostics Laboratory (MDL) at MD Anderson Cancer Center will perform the PAM50 analysis and forward results (eligible versus non-eligible) within three (3) weeks of receipt of the tumor tissue specimen to the ordering physician via FAX and to the ECOG-ACRIN Operations Office via secure electronic messaging to the ECOG-ACRIN database
      • NOTE: Every effort should be made to submit the tumor tissue specimen to the ECOG-ACRIN CBPF immediately; tumor tissue cannot be accepted after 12 weeks (post surgery) in order to allow for PAM50 analysis
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): For patients randomized to the chemotherapy arm, cycle 1/day 1 must start within 1 week (5 working days) following randomization
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Must have basal-like gene expression on PAM50 analysis by digital mRNA quantitation on the formalin-fixed paraffin-embedded tumor tissue specimen (FFPE) of the residual disease in the breast or axilla resected at the time of definitive surgery
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): ECOG performance status 0 or 1 within 2 weeks prior to randomization
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must have completed adjuvant radiotherapy >= 2 weeks prior to randomization for protocol therapy, if applicable
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must have completed treatment with any investigational agent >= 30 days prior to randomization for protocol therapy, if applicable
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Patients must be randomized within 15 weeks from surgery
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Women must not be pregnant or breast-feeding; all females of childbearing potential must have a blood test or urine study within 2 weeks prior to randomization to rule out pregnancy
    • A female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following criteria: 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception or to abstain from sexual intercourse for the duration of their participation in the study
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Hemoglobin (Hgb) > 9.0 g/dL
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Platelets > 100 mm^3
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Absolute neutrophil count (ANC) > 1500 mm^3
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Calculated creatinine clearance of > 50 mL/min
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Bilirubin =< 1.5="" x="" uln="" (except="" in="" patients="" with="" documented="" gilbert's="" disease,="" who="" must="" have="" a="" total="" bilirubin="" />< 3.0="" mg="" dl)="" />
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Aspartate aminotransferase (AST, SGOT) =< 2.5="" x="" />
  • ELIGIBILITY CRITERIA FOR RANDOMIZATION (STEP 1): Alanine aminotransferase (ALT, SGPT) =< 2.5="" x="" />

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NSABP B-51/RTOG 1304

A Randomized Phase III Clinical Trial Evaluating Post-Mastectomy Chestwall and Regional Nodal XRT and Post-Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

Physician & Study Coordinator

Study Coordinator

Lauren Downing, BS
484-526-7936

Lauren.downing@sluhn.org

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Synopsis

Treatment Agent: Radiation

Synopsis: The main purpose of this clinical trial is to study women like you who have cancer cells in the lymph nodes at the time that the breast cancer is diagnosed and have chemotherapy before surgery that clears the cancer cells from the lymph nodes. For women with breast cancer who do not have cancer cells in the lymph nodes removed at surgery, radiation is usually given to the breast only after lumpectomy and not at all after mastectomy.

This study asks if adding radiation to the lymph nodes (after lumpectomy) or adding radiation to the area where the breast used to be and the lymph nodes (after mastectomy) is better at keeping the cancer from returning. It also asks whether giving radiation as described above will help women live longer.

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Inclusion Criteria
  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • The patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patient must have clinically T1-3, N1 breast cancer at the time of diagnosis (before neoadjuvant therapy); clinical axillary nodal involvement can be assessed by palpation, ultrasound, CT scan, magnetic resonance imaging (MRI), positron emission tomography (PET) scan, or PET/CT scan
  • Patient must have had pathologic confirmation of axillary nodal involvement at presentation (before neoadjuvant therapy) based on either a positive fine needle aspirate (FNA) (demonstrating malignant cells) or positive core needle biopsy (demonstrating invasive adenocarcinoma); the FNA or core needle biopsy can be performed either by palpation or by image guidance; documentation of axillary nodal positivity by sentinel node biopsy (before neoadjuvant therapy) is not permitted
  • Patients must have had estrogen receptor (ER) analysis performed on the primary breast tumor before neoadjuvant therapy according to current American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guideline recommendations for hormone receptor testing; if negative for ER, assessment of progesterone receptor (PgR) must also be performed according to current ASCO/CAP guideline recommendations for hormone receptor testing (http://www.asco.org)
  • Patients must have had HER2 testing performed on the primary breast tumor before neoadjuvant chemotherapy according to the current ASCO/CAP guideline recommendations for human epidermal growth factor receptor 2 testing in Breast Cancer (http://www.asco.org); patients who have a primary tumor that is either HER2-positive or HER2-negative are eligible
  • Patient must have completed a minimum of 12 weeks of standard neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen
  • For patients who receive adjuvant chemotherapy after surgery, a maximum of 12 weeks of intended chemotherapy may be administered but must be completed before randomization; (if treatment delays occur, chemotherapy must be completed within 14 weeks); the dose and schedule of the adjuvant chemotherapy are at the investigator's discretion; Note: It is preferred that all intended chemotherapy be administered in the neoadjuvant setting
  • Patients with HER2-positive tumors must have received neoadjuvant trastuzumab or other anti-HER2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen), unless medically contraindicated
  • At the time of definitive surgery, all removed axillary nodes must be histologically free from cancer; acceptable procedures for assessment of axillary nodal status at the time of surgery include:
    • Axillary node dissection
    • Sentinel node biopsy alone or
    • Sentinel node biopsy followed by axillary node dissection
    • Note: Patients are eligible whether there is residual invasive carcinoma in the surgical breast specimen or whether there is evidence of pathologic complete response; patients who are found to be pathologically node-positive at the time of surgery, based on sentinel node biopsy alone, are candidates for A011202, a study developed by the Alliance in Oncology, an NCI Cooperative Group; if A011202 is open at the investigator's institution, patients should be approached about participating in the A011202 study
  • Patients with pathologic staging of ypN0(i+) or ypN0(mol+) are eligible (Note: Postneoadjuvant therapy is designated with a "yp" prefix.)
  • Patient who have undergone either a total mastectomy or a lumpectomy are eligible
  • For patients who undergo lumpectomy, the margins of the resected specimen or re-excision must be histologically free of invasive tumor and DCIS as determined by the local pathologist; additional operative procedures may be performed to obtain clear margins; if tumor is still present at the resected margin after re-excision(s), the patient must undergo total mastectomy to be eligible; (patients with margins positive for lobular carcinoma in situ [LCIS] are eligible without additional resection)
  • For patients who undergo mastectomy, the margins must be histologically free of residual (microscopic or gross) tumor
  • The interval between the last surgery for breast cancer (including re-excision of margins) and randomization must be no more than 56 days; also, if adjuvant chemotherapy was administered, the interval between the last chemotherapy treatment and randomization must be no more than 56 days
  • The patient must have recovered from surgery with the incision completely healed and no signs of infection
  • If adjuvant chemotherapy was administered, chemotherapy-related toxicity that may interfere with delivery of radiation therapy should have resolved

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Exclusion Criteria
  • Definitive clinical or radiologic evidence of metastatic disease
  • T4 tumors including inflammatory breast cancer
  • Documentation of axillary nodal positivity before neoadjuvant therapy by sentinel node biopsy alone
  • N2 or N3 disease detected clinically or by imaging
  • Patients with histologically positive axillary nodes post neoadjuvant therapy
  • Patients with microscopic positive margins after definitive surgery
  • Synchronous or previous contralateral invasive breast cancer or DCIS; (patients with synchronous and/or previous contralateral LCIS are eligible)
  • Any prior history, not including the index cancer, of ipsilateral invasive breast cancer or ipsilateral DCIS treated with radiation therapy; (patients with synchronous or previous ipsilateral LCIS are eligible)
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization
  • Any radiation therapy for the currently diagnosed breast cancer prior to randomization
  • Any continued use of sex hormonal therapy, e.g., birth control pills, ovarian hormone replacement therapy; patients are eligible if these medications are discontinued prior to randomization
  • Prior breast or thoracic radiation therapy (RT) for any condition
  • Active collagen vascular disease, specifically dermatomyositis with a creatinine phosphokinase (CPK) level above normal or with an active skin rash, systemic lupus erythematosus, or scleroderma
  • Pregnancy or lactation at the time of study entry; (Note: Pregnancy testing must be performed within 2 weeks prior to randomization according to institutional standards for women of childbearing potential)
  • Other non-malignant systemic disease that would preclude the patient from receiving study treatment or would prevent required follow-up
  • Psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements

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Pfizer A5481082

POLARIS: Palbociclib in Hormone Receptor Positive Advanced Breast Cancer: A Prospective Multicenter Non-Interventional

Physician & Study Coordinator

Study Coordinator

Lauren Downing, BS
484-526-7936

Lauren.downing@sluhn.org

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Synopsis

Treatment Agent: N/A

Synopsis: You are being asked to take part in this research study because you have breast cancer. There is a need to learn more about the use of palbociclib in routine clinical practice. For this reason, Pfizer is conducting a prospective non-interventional study to collect additional information on the good and bad effects of the drug, palbociclib, which has been prescribed to you by your doctor.

The main goal of this study is to describe and analyze the prescribing and treatment patterns of palbociclib in routine clinical practice. The study will collect and assess information related to how you are treated by your doctor and also it will collect information about your experience.

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Inclusion Criteria
  • Age ≥18 years or older.
  • Diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or advanced disease not amenable to treatment with curative intent.
  • Documented HR+ (ER+ and/or PR+) tumor based on local standards.
  • Documented HER2- tumor based on local standards.
  • Physician has determined that treatment with palbociclib is indicated.
  • Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
  • Patients who in the opinion of the investigator are willing and able to comply with regular clinic visits as per standard of care practice at the site.

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Exclusion Criteria
  • Patients with a life expectancy of less than 3 months at the time of ABC diagnosis, per the investigator’s judgment.
  • Patients participating in any interventional clinical trial that includes investigational or marketed products at the time of enrollment. (Patients participating in other investigator initiated research or NIS can be included as long as their standard of care is not altered by the study).
  • Patients on active treatment for malignancies other than ABC at the time of enrollment.
  • Patients who are unable to understand the nature of the study and are unwilling to sign an informed consent.

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Pfizer C3441020

A Phase 2, Non-Randomized, Open Label, Single Arm, Multi-Center Study of Talazoparib for Neoadjuvant Treatment of Germline BRCA 1/2 Mutation Patients with Early Triple- Negative Breast Cancer

Physician & Study Coordinator

Study Coordinator

Lauren Downing, BS
484-526-7936
Lauren.downing@sluhn.org

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Synopsis

Treatment Agent: Talazoparib

Synopsis: You are being asked to take part in this study because you have early stage triple‑negative breast cancer and may be a carrier of a BRCA gene mutation. The purpose of this study is to determine if the study drug talazoparib (also called BMN 673) is safe when given as a breast cancer treatment and to evaluate how your cancer responds. Talazoparib is given in a capsule and is taken by mouth at approximately the same time every day.

Before you enter this study, you may be asked to provide a blood sample to see if you have a certain mutation in genes known as BRCA. If the results confirm that your BRCA1 or BRCA2 gene is mutated you may be provided with some additional cancer risk information (this information has not been reviewed or approved by Food and Drug Administration [FDA] and does not form part of the research study.  If you have already had a BRCA test, your doctor will review the test results to determine if these results may be used or if another sample will be taken.

  

 

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Inclusion Criteria
  • Germline BRCA 1/2 Mutation Positive
  • Women and men at least 18 years of age or older.
  • Histologically confirmed invasive triple negative Breast Cancer
  • Tumor greater than or equal toT1
  • No evidence of distant metastasis
  • Adequate bone marrow, hepatic, and renal function
  • ECOG performance status 0 or 1

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Exclusion Criteria
  • Any other previous antitumor therapies for the current cancer event. Treatment for ductal carcinoma in situ (DCIS) is allowed; ie, surgery, hormonal therapy and radiation.
  • Evidence of distant metastasis apparent prior to randomization
  • Patients with inflammatory breast carcinoma
  • Malignancy within the last 3 years, except:: Adequately treated non melanoma skin cancer; Curatively treated in situ cancer of the cervix; Stage 1, Grade 1 endometrial carcinoma; or Adequately treated contralateral breast carcinoma which has been disease free for a year; Other solid tumors including lymphomas (without bone marrow involvement) curatively treated with no evidence of disease for 5 years.
  • Previous or concomitant systemic anti cancer therapies used for the treatment of cancer in the last 3 years.
  • Prior treatment with a PARP inhibitor in any disease setting
  • Concomitant use of Strong P gp inhibitors or inducers or BCRP inhibitors
  • Patients who are unwilling or unable to use 2 highly effective methods of contraception as outlined in this protocol
  • Major surgery within 14 days prior to study entry
  • Known history of cardiac disease, for example : Myocardial infarction or symptomatic cardiac ischemia within 24 weeks before screening; Congestive heart failure New York Heart Association Class III or IV; History of clinically significant ventricular arrhythmias within one year prior to randomization; History of Mobitz II second degree or third degree heart block, uncontrolled hypertension.
  • Active clinically significant infection
  • Clinically significant bleeding diathesis or coagulopathy
  • Non healing wound, ulcer or bone fracture
  • Known hypersensitivity to any of the components of talazoparib
  • Patients with myelodysplastic syndrome/acute myeloid leukemia
  • Patients with uncontrolled seizures.
  • Any evidence of other disease or any concomitant medical or psychiatric problems which in the opinion of the Investigator would prevent completion of treatment

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PreludeDx DCISionRT Registry

Prospective Registry Study to Evaluate the Effect of the DCISionRT Test on Treatment Decisions in Patients with DCIS Following Breast Conserving Therapy

Physician & Study Coordinator

Physician

Lee Riley, MD

Lee Riley, MD

Study Coordinator

Lauren Downing, BS
484-526-7936

Lauren.downing@sluhn.org

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Synopsis

Treatment Agent: N/A

Synopsis: This Registry is keeping track of people who are undergoing therapy for ductal carcinoma in situ (DCIS) and who are having genomic testing. This type of genomic testing looks at how certain genes are used by your tumor cells.

  • The goal of this Registry is to help researchers understand the value of genomic testing in the choice of therapy for DCIS patients.
  • The Registry will record information including the results of genomic testing on your tissue.
  • This Registry will eventually contain information from thousands of people who are undergoing DCIS treatment.
  • This research study will hopefully result in a future change in disease treatment and improvement of care for people with DCIS.

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Inclusion Criteria
  1. Patient must have histologically confirmed ductal carcinoma in situ (DCIS) in a single breast (presence of lobular carcinoma in situ (LCIS) or other benign breast disease in addition to DCIS is acceptable)
  2. Patient must have the DCISionRT Test ordered during routine patient care
  3. Patient must be planning to undergo breast conserving surgery
  4. Patient must be eligible to receive radiation and/or systemic treatment
  5. Patient must be greater than 25 years old
  6. Patient must have been diagnosed with DCIS within 120 days of consent
  7. Patient must be able to provide informed consent

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Exclusion Criteria
  1. Patient tissue is insufficient to generate DCISionRT test results or required DCISionRT inputs (age, tumor size, margin status, palpability) are missing
  2. Patient has evidence of invasive breast cancer, including microinvasion, lymph node involvement, or Paget’s disease of the nipple or suspicious mammogram findings in the lymph nodes or contralateral breast
  3. Patient has been surgically treated with a mastectomy for primary DCIS
  4. Patient has prior in situ or invasive breast cancer
  5. Patient is pregnant
  6. Patient was previously enrolled onto this registry

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NRG-BR004

A Randomized, Double-Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First-Line HER2-Positive Metastatic Breast Cancer

Physician & Study Coordinator

Physician

Hikaru Nakajima, MD

Hikaru Nakajima, MD

Study Coordinator

Lauren Downing, BS
484-526-7936

Lauren.downing@sluhn.org

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Synopsis

Treatment Agent: Atezolizumab

Synopsis: The purpose of this study is to compare the usual treatment plus placebo to the usual treatment plus atezolizumab.  The addition of atezolizumab to the usual treatment could stabilize the cancer. This study will help the study doctors find out if this different approach is better, the same, or worse than the usual approach.  To decide if it is better, the study doctors will be looking to see if the atezolizumab lengthens the time during and after the treatment of the cancer and that it is stable. Atezolizumab is already approved by the FDA for use in non-small cell lung cancer and urinary cancer.  Its use in this study is considered experimental. 

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Inclusion Criteria
  • The patient must have signed and dated an Institutional Review Board (IRB)-approved consent form that conforms to federal and institutional guidelines
  • Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Histologically confirmed adenocarcinoma of the breast with locally recurrent, unresectable disease or metastatic disease confirmed as described below; eligible patients include those with either:
    • De novo metastatic disease presenting without prior history of HER2-positive breast cancer:
      • Diagnosis should have been made from a biopsy of a metastatic disease site, but biopsy from the breast primary or involved regional lymph nodes is acceptable if biopsy of the metastatic sites was thought to carry excessive risk for the patient
    • Locally recurrent or metastatic disease following prior therapy for early breast cancer:
      • Diagnosis must have been made from the biopsy of the locally recurrent or metastatic disease
      • There must be an interval of >= 6 months between completion of neoadjuvant/adjuvant HER2-targeted therapy and documentation of locally recurrent or metastatic HER2-positive disease by biopsy
  • Patients must have measurable disease based on RECIST 1.1, as determined by the site, to be eligible
  • The tumor specimen obtained at the time of diagnosis of locally recurrent or metastatic disease must have been determined to be HER2-positive based on central testing according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines (Wolff 2018); HER2 status will initially be assessed using a Food and Drug Administration (FDA)-cleared IHC assay; positive is defined as IHC 3+ staining intensity; if HER2 IHC results are equivocal (2+), then HER2 status will be determined using a FDA-cleared HER2 in situ hybridization (ISH) test according to ASCO/CAP guidelines; sites can send biopsy specimens for central testing which have been determined to be HER2-positive or initially equivocal by either IHC or ISH on local testing
  • The tumor specimen obtained at the time of diagnosis used for HER2 testing must also have central testing for PD-L1 status; patients will be eligible irrespective of PD-L1 testing result including PD-L1 indeterminant
  • The tumor specimen obtained at the time of diagnosis used for HER2 and PD-L1 testing should also have central testing for estrogen receptor (ER) and progesterone receptor (PgR) according to current ASCO/CAP guideline recommendations for hormone receptor testing; patients with , 1% ER and PgR staining by IHC will be classified as negative; if sufficient material for central confirmation of ER and PgR is unavailable, local testing results for ER and PgR may be used for eligibility
  • Localized palliative radiation therapy is allowed for symptom management if completed >= 14 days prior to randomization
  • Patients must have imaging of the chest/abdomen/pelvis, preferably with a computed tomography (CT) scan, and a bone scan within 4 weeks prior to randomization; (NOTE: if a patient is unable to receive CT contrast, a magnetic resonance imaging [MRI] of the abdomen/pelvis and non-contrast chest CT should be performed; positron emission tomography/computed tomography [PET/CT] is not an acceptable alternative)
  • MRI of the brain (or contrast CT scan of the brain if patients are unable to undergo MRI) must be obtained in patients with symptoms suggesting possible central nervous system (CNS) metastatic disease; neuroimaging is recommended but not required in asymptomatic patients
  • Absolute neutrophil count (ANC) must be >= 1200/mm^3 (within 14 days prior to randomization)
  • Platelet count must be >= 100,000/mm^3 (within 14 days prior to randomization)
  • Hemoglobin must be >= 8 g/dL (within 14 days prior to randomization)
  • Total bilirubin must be =< 1.5 x upper limit of normal (ULN) for the lab or direct bilirubin =< ULN for patients with bilirubin levels > 1.5 x ULN (within 14 days prior to randomization)
  • Aspartate aminotransferase (AST) and alanine aminotransaminase (ALT) must be =< 2.5 x ULN for the lab or =< 5 x ULN for patients with liver metastases (within 14 days prior to randomization)
  • Serum creatinine =< 1.5 x ULN or measured or calculated creatinine clearance >= 50 mL/min using the Cockroft-Gault formula for patients with creatinine levels > 1.5 x ULN for the lab (within 14 days prior to randomization)
  • Patients not receiving anti-coagulant therapy must have prothrombin time (PT) and international normalized ratio (INR) =< 1.5 x ULN within 14 days prior to randomization; for laboratories that do not report an ULN for the INR assay, use =< 1.5 as the value for the ULN; patients receiving anti-coagulants should have a baseline INR assessed, but the value does not affect eligibility
  • A serum thyroid-stimulating hormone (TSH), free T4, and AM (morning) cortisol must be obtained within 14 days prior to randomization to obtain a baseline value and be within normal limits for the local laboratory
  • Left ventricular ejection fraction (LVEF) assessment must be performed within 6 weeks prior to randomization; (LVEF assessment performed by echocardiogram is preferred; however, multigated acquisition scan (MUGA) scan may be substituted based on institutional preferences); the LVEF must be >= 55% regardless of the cardiac imaging facility's lower limit of normal
  • Administration of atezolizumab may have an adverse effect on pregnancy and poses a risk to the human fetus, including embryo-lethality; women of child-bearing potential and men must agree to use adequate contraception (non-hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation, and for 5 months (150 days) after the last dose of atezolizumab/placebo and 7 months after the last dose of trastuzumab and pertuzumab; should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately

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Exclusion Criteria
  • Patients with known primary central nervous system (CNS) malignancy or symptomatic CNS metastases are excluded, with the following exceptions:
    • Patients with asymptomatic untreated CNS disease may be enrolled, provided all of the following criteria are met:
      • Evaluable or measurable disease outside the CNS
      • No metastases to brain stem, midbrain, pons, medulla, cerebellum, or within 10 mm of the optic apparatus (optic nerves and chiasm)
      • No history of intracranial hemorrhage or spinal cord hemorrhage
      • No ongoing requirement for dexamethasone for CNS disease; patients on a stable dose of anticonvulsants are permitted
      • No neurosurgical resection or brain biopsy within 28 days prior to randomization
    • Patients with asymptomatic treated CNS metastases may be enrolled, provided all the criteria listed above are met as well as the following:
      • Radiographic demonstration of improvement upon the completion of CNS directed therapy and no evidence of interim progression between the completion of CNS directed therapy and the screening radiographic study
      • No stereotactic radiation or whole-brain radiation within 4 weeks prior to randomization
      • Screening CNS radiographic study 4 weeks from completion of radiotherapy and 2 weeks from discontinuation of corticosteroids
  • Known leptomeningeal carcinomatosis
  • Patients with metastatic disease limited to the CNS
  • History of systemic anti-cancer therapy (e.g., chemotherapy, targeted therapy) for metastatic breast cancer (MBC) with the exception of administration of trastuzumab or lapatinib concurrently with radiation therapy for brain metastases; toxicities related to lapatinib should be =< grade="" 1,="" per="" the="" ctcae="" version="" (v)5.0="" and="" must="" have="" been="" completed="" at="" least="" 2="" weeks="" prior="" to="" randomization="" />
  • History of exposure to cumulative doses of doxorubicin greater than 360 mg per square meter of body-surface area or its equivalent
  • Prior treatment with mTOR inhibitors or CDK 4/6 inhibitors in combination with endocrine therapy for treatment of metastatic disease
  • Prior treatment with CD137 agonists or immune checkpoint-blockade therapies, including anti-CD40, anti-CTLA-4, anti-PD-1, and anti-PD-L1 therapeutic antibodies
  • History of non-breast malignancies (except for in situ cancers treated only by local excision and basal cell and squamous cell carcinomas of the skin) within 5 years prior to randomization
  • Uncontrolled hypertension defined as sustained systolic blood pressure (BP) > 150 mmHg or diastolic BP > 90 mmHg; (patients with initial BP elevations are eligible if initiation or adjustment of BP medication lowers pressure to meet entry criteria)
  • History of asymptomatic LVEF decline to < 40%="" during="" or="" after="" prior="" her2-targeted="" therapy="" />
  • Cardiac disease (history of and/or active disease) that would preclude the use of the drugs included in the treatment regimens; this includes but is not confined to:
    • Active cardiac disease
      • Angina pectoris that requires the current use of anti-anginal medication;
      • Ventricular arrhythmias except for benign premature ventricular contractions;
      • Supraventricular and nodal arrhythmias requiring a pacemaker or not controlled with medication;
      • Conduction abnormality requiring a pacemaker;
      • Valvular disease with documented compromise in cardiac function; or
      • Symptomatic pericarditis
    • History of cardiac disease
      • Prior myocardial infarction documented by elevated cardiac enzymes or persistent regional wall abnormalities on assessment of left ventricular (LV) function;
      • History of documented congestive heart failure (CHF) defined as symptomatic heart failure with an LVEF < 40%;="" or="" />
      • Documented cardiomyopathy
  • Nervous system disorder (paresthesia, peripheral motor neuropathy, or peripheral sensory neuropathy) >= grade 2, per the Common Terminology Criteria for Adverse Events (CTCAE) version (v) 5.0
  • History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
  • Known hypersensitivity to biopharmaceuticals produced in Chinese hamster ovary cells or other recombinant antibodies
  • Known allergy or hypersensitivity to the components of the atezolizumab formulation or to any of the study drugs or excipients, (e.g., Cremophor EL)
  • History or risk of autoimmune disease, including, but not limited to, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener's granulomatosis, Sjogren's syndrome, Bell's palsy, Guillain-Barre syndrome, multiple sclerosis, autoimmune thyroid disease, vasculitis, or glomerulonephritis
    • Patients with a history of autoimmune hypothyroidism on a stable dose of thyroid replacement hormone may be eligible
    • Patients with controlled type 1 diabetes mellitus on a stable insulin regimen may be eligible
    • Patients with eczema, psoriasis, lichen simplex chronicus of vitiligo with dermatologic manifestations only (e.g., patients with psoriatic arthritis would be excluded) are permitted provided that they meet the following conditions:
      • Patients with psoriasis must have a baseline ophthalmologic exam to rule out ocular manifestations
      • Rash must cover less than 10% of body surface area (BSA)
      • Disease is well controlled at baseline and only requiring low-potency topical steroids (e.g., hydrocortisone 2.5%, hydrocortisone butyrate 0.1%, flucinolone 0.01%, desonide 0.05%, aclometasone dipropionate 0.05%)
      • No acute exacerbations of underlying conditions within the last 12 months (not requiring psoralen plus ultraviolet A radiation [PUVA], methotrexate, retinoids, biologic agents, oral calcineurin inhibitors; high potency or oral steroids)
  • Treatment with systemic immunosuppressive medications (including but not limited to interferons, IL-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to randomization
  • Treatment with systemic immunosuppressive medications (including but not limited to prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti−tumor necrosis [anti-TNF] factor agents) within 14 days prior to randomization or anticipation of need for systemic immunosuppressive medications during the study; Note: Intranasal and inhaled corticosteroids or systemic corticosteroids at doses that do not exceed 10 mg/day of prednisone or an equivalent corticosteroid are allowed
  • Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 2 weeks prior to randomization
  • Active hepatitis B virus (HBV) infection, defined as having a positive hepatitis B surface antigen (HBsAg) test at screening; patients with a past or resolved HBV infection, defined as having a negative HBsAg test and a positive total hepatitis B core antibody (HBcAb) test at screening, are eligible for the study if active HBV infection is ruled out on the basis of HBV deoxyribonucleic acid (DNA) viral load per local guidelines
  • Active hepatitis C virus (HCV) infection, defined as having a positive HCV antibody test at screening confirmed by a polymerase chain reaction (PCR) positive for HCV ribonucleic acid (RNA)
  • Patients with clinically active tuberculosis
  • Patients known to be human immunodeficiency virus (HIV) positive are eligible if they meet the following criteria within 4 weeks prior to randomization:
    • A stable regimen of highly active anti-retroviral therapy (HAART) and;
    • No requirement for concurrent antibiotics or antifungal agents for the prevention of opportunistic infections; and
    • A CD4 count above 250 cells/mcL and an undetectable HIV viral load on standard PCR-based tests
  • Severe infection within 4 weeks prior to randomization, including but not limited to hospitalization for complications of infection, bacteremia, or severe pneumonia
  • Prior allogeneic stem cell or solid organ transplantation
  • Symptomatic peripheral ischemia
  • History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis or >= grade 1 pulmonary fibrosis, per the CTCAE v5.0, on screening chest CT scan
  • Administration of a live, attenuated vaccine within 4 weeks prior to randomization or anticipation that such vaccine will be required during the study
    • Patients must agree not to receive live, attenuated influenza vaccine (e.g., FluMist) within 4 weeks prior to randomization, during treatment or within 5 months following the last dose of atezolizumab/placebo
  • Any other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease

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