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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Eli Lilly 13Y-MC-JPCF

A Randomized, Open-Label, Phase 3 Study of Abemaciclib combined with Standard Adjuvant Endocrine Therapy versus Standard Adjuvant Endocrine Therapy Alone in Patients with High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 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: Abemaciclib

Synopsis: The main reason for you to take part in this study is not to treat you for your condition but to help in answering the following research question:

*Whether the combination of abemaciclib (LY2835219) plus adjuvant endocrine therapy decreases the proportion of relapses after surgery in patients with a certain type of breast cancer compared to adjuvant endocrine therapy alone.

“Investigational” means that the drug being tested has not been approved for routine clinical use or for the use described in this study by the United States Food and Drug Administration (FDA).  However the FDA has allowed the use of this drug for research.

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Inclusion Criteria
  • Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations).
  • The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
  • The participant must have undergone definitive surgical treatment for the current malignancy.
  • The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization.
  • The participant must have axillary lymph node involvement by tumor and have one of the following indicating a higher risk of relapse:
    • 4 or more axillary lymph nodes involved with cancer
    • Tumor size of at least 5 centimeters
    • Grade 3 histology
    • Ki67 index by central analysis of ≥20% on untreated breast tissue
  • The participant must be randomized within 16 months from the time of surgery.
  • If the participant is currently receiving or initiating standard adjuvant endocrine therapy at time of study entry, she/he must not have received more than 12 weeks of adjuvant endocrine therapy following his/her last non-endocrine therapy (surgery, chemotherapy, or radiation).
  • Participants must have recovered from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery.
  • Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods.
  • The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
  • The participant has adequate organ function.
  • The participant is able to swallow oral medications.

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Exclusion Criteria
  • Stage IV (M1), Stage IA, and lymph node negative breast cancer.
  • Participants with a history of previous breast cancer are excluded, with the exception of lobular carcinoma in situ (LCIS) or ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years are excluded.
  • Females who are pregnant or lactating.
  • The participant has previously received treatment with any CDK4 and CDK6 inhibitor.
  • The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).
  • The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or raloxifene or aromatase inhibitors).
  • The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
  • The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE) (for example, deep vein thrombosis [DVT] of the leg or arm and/or pulmonary embolism) will be excluded.
  • The participant has active bacterial infection, fungal infection, or detectable viral infection or viral load.
  • The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.

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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 A5481074

Prospective Observational Study of Mobile App-Based Patient-Reported Outcomes in Advanced Breast Cancer (Madeline)

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 eligible to take part in this research study because you are beginning treatment for locally advanced or metastatic hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2–) breast cancer. There is a need to learn more about the experiences and quality of life among patients who are being treated for this disease. For this reason, Pfizer is conducting a non-interventional study to collect information about the effects of breast cancer and its treatment on patients’ day-to-day activities and quality of life.

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Inclusion Criteria
  • Owns or has regular access to an Apple iPhone (version 5.0 or higher with latest software: iOS 9.0 or higher) or Android phone (e.g., Nexus or Galaxy with latest software: version 4.4.2 or higher).
  • Postmenopausal adult women (≥ 18 years of age) with diagnosis of adenocarcinoma of the breast with evidence of metastatic disease or locoregionally advanced disease not amenable to resection or radiation therapy with curative intent.
  • Documented evidence of HR+ tumor based on the patient’s most recent tumor biopsy.
  • Documented evidence of an HER2– tumor based on the patient’s most recent tumor biopsy. HER2– is determined as an immunohistochemistry score of 0/1+ or negative by in situ hybridization (FISH/CISH/SISH) defined as a HER2/CEP17 ratio < 2 or, for single probe assessment, a HER2 copy number < 4).
  • Initiating first, second or third line treatment with one of the following therapies: IBRANCE and letrozole as initial endocrine-based therapy for advanced or metastatic disease as per label, or IBRANCE with fulvestrant if the patient has experienced disease progression following endocrine therapy as per label, or other approved therapy as the first treatment for advanced or metastatic breast cancer, or initiating other approved therapy as the second or third treatment for ABC or mBC.
  • Evidence of a personally signed and dated informed consent form document indicating that the patient has been informed of all pertinent aspects of the study.
  • Able to read and understand English
  • Willing and able to complete collection of data via mobile app.

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Exclusion Criteria
  • Patient is initiating neoadjuvant systemic therapy.
  • In the judgment of the investigator, the patient’s life expectancy is fewer than 3 months at the time of diagnosis of ABC or mBC.
  • The patient is participating in any interventional clinical trial that includes investigational or marketed products. Patients participating in other investigator initiated research or non-interventional studies can be included as long as their standard of care is not altered by the study.
  • The patient is on active treatment for other malignancies other than ABC or mBC.

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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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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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SWOG 1207

Phase III Randomized, Placebo-Controlled Clinical Trial Evaluating the Use of Adjuvant Endocrine Therapy +/- One Year of Everolimus in Patients with High-Risk, Hormone Receptor-Positive and HER2/neu 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: Everolimus

Synopsis: The purpose of this study is to see whether treatment with everolimus plus hormone treatment after chemotherapy will increase the time without your cancer returning. The current standard treatment after chemotherapy is hormone treatment alone. Everolimus is a drug currently approved for the treatment of patients with advanced or metastatic kidney or breast cancer. It is considered investigational for non-metastatic breast cancer patients. In this study you will get hormone treatment with either everolimus or with placebo (a pill with no medication). The combination of hormone-treatment and everolimus is experimental in patients with breast cancer.

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Inclusion Criteria
  • Patients must have a histologically confirmed diagnosis of invasive breast carcinoma with positive estrogen (ER)- and/or progesterone-receptor (PR) status, and negative human epidermal growth factor receptor (HER)2, for whom standard adjuvant endocrine therapy is planned
    • ER and PR positivity must be assessed according to American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP) guidelines as either ER or PR ≥ 1% positive nuclear staining
    • HER2 test result negativity must be assessed as per ASCO/CAP 2013 guidelines using IHC, ISH or both. HER2 is negative if a single test (or all tests) performed in a tumor specimen show:
      • IHC negative (0 or 1+)
      • ISH negative using single probe or dual probe. If IHC is 2+, evaluation for gene amplification (ISH) must be performed and the ISH must be negative; ISH is not required if IHC is 0 or 1+. HER2 equivocal is not eligible.
  • Patients must not have metastatic breast cancer (stage IV disease); patients with multifocal, multicentric, and synchronous bilateral, and primary inflammatory breast cancers are allowed
    • Multifocal disease is defined as more than one invasive cancer < 2="" cm="" from="" the="" largest="" lesion="" within="" the="" same="" breast="" />
    • Multicentric disease is defined as more than one invasive cancer ≥ 2 cm from the largest lesion within the same breast quadrant or more than one lesion in different quadrants
    • Synchronous bilateral disease is defined as invasive breast cancer with positive lymph nodes (axillary or intramammary) in at least one breast, diagnosed within 30 days of each other
  • Patients must be high risk by belonging to one of the following risk groups:
    • Completion of adjuvant chemotherapy and pathologically negative axillary nodes, and a tumor measuring ≥ 2 cm in greatest diameter, and an Oncotype DX® recurrence score (RS) > 25 (completed as standard of care)
    • Completion of adjuvant chemotherapy, and pathologically 1-3 positive axillary lymph nodes, and an Oncotype DX® RS > 25 (screened via S1007 or otherwise)
    • Completion of adjuvant chemotherapy and pathologically 4 or more positive axillary lymph nodes independent of the Oncotype DX® RS in the primary tumor
    • Completion of neoadjuvant chemotherapy and 4 or more positive nodes pathologically determined prior to or after chemotherapy
  • Patients must have completed either breast-conserving surgery or total mastectomy, with negative margins and appropriate axillary staging; a negative margin is defined as no evidence of tumor or ductal carcinoma in situ (DCIS) at the line of resection; additional operative procedures may be performed to obtain clear margins
    • Patients who had breast-conserving surgery must have completed whole-breast radiation; use of regional nodal-basin radiation will be at the discretion of the investigator according to institutional guidelines
    • Patients with ≥ 4 positive lymph nodes must have completed breast/chest wall and nodal-basin radiation therapy according to standard-of-care guidelines before randomization; omission of radiation therapy is not allowed in this high-risk population of patients
    • Patients must be registered no sooner than 21 days after completion of radiation therapy and must have recovered (≤ grade 1) from any of the effects of radiation
  • Patients must have undergone axillary staging by sentinel-node biopsy or axillary lymph node dissection (ALND)
    • For patients with 1-3 positive lymph nodes, sentinel-node biopsy alone is allowed provided that the patient completed either whole-breast or chest-wall radiation and the primary tumor is < 2="" />
    • All patients with ≥ 4 positive lymph nodes must have completed ALND (with or without prior sentinel-node biopsy)
  • Peripheral granulocyte count ≥ 1,500/mL
  • Hemoglobin ≥ 9 g/dL
  • Platelet count ≥ 100,000/mL
  • Bilirubin ≤ 1.5 mg/dL (≤ 3.0 mg/dL if due to Gilbert syndrome)
  • Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 times institutional upper limit of normal (IULN)
  • Alkaline phosphatase ≤ 1.5 times IULN
  • Serum creatinine level ≤ IULN
  • Fasting cholesterol ≤ 300 mg/dL and triglycerides ≤ 2.5 times IULN; patients may be on lipid-lowering agents to reach these values
  • Patients must have a performance status of 0-2 by Zubrod criteria
  • Patients must not have any grade III/IV cardiac disease as defined by the New York Heart Association Criteria (i.e., patients with cardiac disease resulting in marked limitation of physical activity or resulting in inability to carry on any physical activity without discomfort), unstable angina pectoris, myocardial infarction within 6 months, or serious uncontrolled cardiac arrhythmia
  • Patients must not have uncontrolled diabetes (defined as a hemoglobin [Hg] A1C > 7% within 28 days prior to registration)
  • Patients known to be human immunodeficiency virus (HIV) positive may be enrolled if baseline CD4 count is > 500 cells/mm³ and they are not taking anti-retroviral therapy
  • Patients with known hepatitis are not eligible
  • Patients must not have any known uncontrolled, underlying pulmonary disease
  • Patients must be able to take oral medications
  • Patients may not have any impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of blinded drug (e.g., ulcerative disease, uncontrolled nausea, vomiting, diarrhea, malabsorption syndrome, or small bowel resection)
  • Patients must not be pregnant or nursing
  • Women/men of reproductive potential must have agreed to use an effective non-hormonal contraceptive method during and for 8 weeks after completion of study therapy
    • In addition to routine contraceptive methods, "effective contraception" also includes heterosexual celibacy and surgery intended to prevent pregnancy (or with a side-effect of pregnancy prevention) defined as a hysterectomy, bilateral oophorectomy, or bilateral tubal ligation; corresponding procedures for men include castration, vasectomy, and barrier-contractive devices
    • If at any point a previously celibate patient chooses to become heterosexually active during the protocol therapy, he/she is responsible for beginning contraceptive measures
  • No other prior malignancy is allowed except for adequately treated basal cell or squamous cell skin cancer, in situ cervical cancer, or other cancer for which the patient has been disease-free for 5 years

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Exclusion Criteria
  • Patients must have completed standard neoadjuvant or adjuvant chemotherapy prior to randomization; completion of chemotherapy will be determined by the treating oncologist, but should include a minimum of 4 courses (a course of weekly paclitaxel is considered 3 doses); patients must be registered within 21 weeks after completion of chemotherapy; patients may have started endocrine therapy at any time after the diagnosis of the current breast cancer
  • Patients must not be receiving or planning to receive trastuzumab
  • Concurrent bisphosphonate therapy is allowed
  • Patients must not have prior exposure to mTOR inhibitors (rapamycin, everolimus, temsirolimus, deforolimus)
  • Patients must not have prior treatment with any investigational drug within the preceding 28 days and must not be planning to receive any other investigational drug for the duration of the study
  • Patients must not be planning to receive any other anticancer drug for the duration of the study
  • Patients must not have an organ allograft or other history of immune compromise; patients must not be receiving chronic, systemic treatment with corticosteroids or other immunosuppressive agent; topical or inhaled corticosteroids are allowed
  • Patients must not have received immunization with an attenuated live vaccine (e.g., intranasal influenza, measles, mumps, and rubella [MMR], oral polio, varicella, zoster, yellow fever, and Bacillus Calmette-Guérin [BCG] vaccines) within seven days prior to registration nor have plans to receive such vaccination while on protocol treatment
  • Patients must not have taken within 14 days prior to registration, be taking, nor plan to take while on protocol treatment, strong cytochrome P450 3A4 (CYP3A4) inhibitors and/or CYP3A4 inducers

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