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

Study Coordinator

Helen McGunnigle
email: Helen.McGunnigle@sluhn.org
phone: 484-658-5044

Close

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.

Close

Eligibility Criteria
  • Is ≥18 years of age, at the time of signing the informed consent
  • Stage I, II, or III patients who receive MammaPrint, with or without BluePrint testing (male or female) - New primary lesion - Eligible for chemo and endocrine therapy

Close

Alliance A071701

Genomically-Guided Treatment Trial in Brain Metastases (NCT03994796)

Physician & Study Coordinator

Study Coordinator

Angela Rankin
email: Angela.Rankin@sluhn.org
phone: 484-658-1792

 

Close

Synopsis

This is a Phase 2 study evaluating the efficacy of a CDK, PI3K, or NTRK/ROS1 inhibitor in patients with progressive brain metastases from solid tumors harboring the alterations predicting sensitivity to each of these inhibitors.

Close

Eligibility Criteria
  • Histologically confirmed parenchymal metastatic disease to the brain from any solid tumor

  • Tissue must be available for biomarker testing (any brain metastasis tissue and extracranial site from any prior resection or biopsy). If extracranial tissue is not available or there is no evidence of extracrania disease, brain metastasis tissue is sufficient for eligibility

  • Measurable CNS disease (≥ 10mm) that is new or progressive after systemic therapy or prior radiotherapy

  • Patients must be able to undergo MRI with contrast

  • Presence of clinically actionable alteration in NTRK, ROS1, CDK pathway or PI3K pathway in both a brain metastais and extracranial site per central review

  • For HER2+ breast cancer, patients must have received prior HER-2 directed therapy in the metastatic setting

  • For TNBC, patients must have had at least one chemotherpy in the metastatic setting

  • For ER and/or PR+ HER2- breast cancer, patients must have had at least one endocrine therapy in the metastatic setting

  • For melanoma, patietnts must have progressed after immunotherapy or after BRAF/MEK inhibitors for BRAF+ disease

  • For lung cancer, patients must have failed EGFR therapies for EGFR mutated disease

  • No known current diffuse leptomeningeal involvement

  • No surgery within 2 weeks prior to or after registration

  • No chemotherapy within 14 days prior to registration

Close

Eli Lilly J2J-MC-JZLH

A Randomized, Open-Label, Phase 3 Study of Adjuvant Imlunestrant vs Standard Adjuvant Endocrine Therapy in Patients who have Previously Received 2 to 5 Years of Adjuvant Endocrine Therapy for ER+, HER2- Early Breast Cancer with an Increased Risk of Recurrence (NCT 05514054).

Physician & Study Coordinator

Study Coordinator

Helen McGunnigle
email: Helen.McGunnigle@sluhn.org
phone: 484-658-5044

Close

Synopsis

The purpose of this research study is to see how safe an investigational drug (Imlunestrant) is and how well it will work to help people with estrogen receptor positive (ER+), human epidermal growth factor receptor 2-negative (HER2-), early breast cancer with an increased risk of recurrence. Imlunestrant is a selective estrogen receptor degrader (SERD) and therefore should stop or slow down tumor growth in ER+ cancers.

Close

Eligibility Criteria
  • Patients must have ER+, HER2- early-stage, resected, invasive breast cancer without evidence of distant metastasis
  • Patients must have undergone definitive loco-regional therapy (surgery, with or without radiation therapy, and/or systemic therapy where appropriate per guidelines) of the primary index breast tumor(s)
  • Patients must have received at least 24 months but no more than 60 months of any adjuvant ET, from time of adjuvant ET initiation to signing of ICF
  • Prior (neo)adjuvant chemotherapy and/or targeted therapy with a CDK4/6- or PARP- inhibitor is allowed
  • Patients may not have had more than a 6-month consecutive gap in therapy during the course of prior adjuvant ET, may not have completed or discontinued prior adjuvant ET > 6 months prior to screening, and may not have had prior SERD therapy
  • Patients may not receive concurrent exogenous reproductive hormone therapy

Close

GE-380-401

Clinical Utility of Fluoroestradiol F18 PET/CT in Metastatic Breast Cancer Patients with ER-Positive and HER2-Negative Primary Lesions after Progression on First Line Hormonal Therapy.

Physician & Study Coordinator

Physician

Edgar Cheng, MD

Study Coordinator

Carolyn Seith
email: Carolyn.Seith@sluhn.org
phone: 484-658-1789

Close

Synopsis

This study will evaluate the use of the diagnostic imaging agent Fluoroestradiol F18, also called Cerianna, in patients with metastatic breast cancer who have progressive disease on first line hormonal therapy. Cerianna is approved for commercial use by the FDA in the United States. Cerianna is used together with PET/CT scans to take pictures of areas of the body to look for signs of disease. The goal of the study is to evaluate if Cerianna PET/CT scan is clinically useful in guiding your study doctor’s therapeutic management of your cancer by detecting the ER status of the breast cancer cells in your body.

Close

Eligibility Criteria
  • Female patients ≥ 18 years old
  • Post-menopausal or pre-menopausal with known primary breast tumor(s) expressing ER in ≥ 1% of tumor cells by IHC
  • Her2-negative (0, 1+, 2+ FISH negative) primary lesion
  • Metastatic breast cancer with at least 1 identifiable lesion on standard of care imaging assessment, outside of the liver
  • Progressive disease on 1st line hormonal therapy (AI) with or without a CDK4/6 inhibitor or mTOR inhibitor or PI3K inhibitor
  • ECOG 0-2
  • History of administered chemotherapy for metastatic disease is not allowed
  • Isolated hepatic disease is not allowed
  • 8 week washout from tamoxifen and 28 weeks from fulvestrant treatment is required

Close

Nanobiotix 1100

A Phase I Study of NBTXR3 Activated by Radiotherapy for Patients with Advanced Cancers Treated With An Anti-PD-1 Therapy (NCT 03589339)

Physician & Study Coordinator

Physician

William Smith, MD

Study Coordinator

Angela Rankin
email: Angela.Rankin@sluhn.org
phone: 484-658-1792

 

Close

Synopsis

The purpose of this research is to determine the recommended dose(s), safety, efficacy and tolerability of the study drug NBTXR3. NBTXR3 is a sterile white suspension made of hafnium oxide nanoparticles that will be injected directly into the tumor. NBTXR3 is an experimental drug made of extremely small particles with a special coating designed to get inside and stay inside cancer cells. These particles are designed to improve the benefit of Radiation Therapy to treat your cancer. It will be directly injected into a tumor that will then be radiated. After completion of radiation, patients will undergo treatment with immunotherapy with an anti-PD-1 inhibitor at the direction of their medical oncologist.

Close

Eligibility Criteria

Your study doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:

  • Patients must have biopsy-confirmed advanced/unresectable malignant solid tumor diagnosis indicated to receive an FDA-approved anti-PD-1 therapy that:
    • Is inoperable locoregional recurrent or metastatic HNSCC with at least one lesion that is amenable to irradiation within head and neck region, lung or liver
    • Is inoperable cancer of the lung, liver, kidney, bladder, cervix, breast (triple negative) or malignant melanoma that has metastasized to soft tissues, lung (including mediastinal lymph nodes) or liver with at least one lesion that is amenable to irradiation
  • Patients must have received prior anti-PD-1 therapy and meet criteria consistent with anti-PD-1 primary or secondary resistance or have not received anti-PD-1 therapy (i.e., anti-PD1 naïve)
  • Patients must have at least one tumor lesion that can be accurately measured according and is amenable for intratumoral injection and amenable for irradiation, as determined by the study investigator
  • Patients cannot have a history of immune-related adverse events related to the administration of anti-PD-1/L1 that led to the termination of the previous anti-PD-1 therapy due to intolerance or toxicity and precludes further PD-1 exposure.
  • Symptomatic central nervous system metastases and/or carcinomatous meningitis is not allowed
  • Active autoimmune disease that has required systemic treatment in 1 year before study treatment (i.e., with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs) is not allowed
  • Extensive metastatic disease burden defined as more than five lesions overall including the primary tumor is not allowed
  • Patients must not have received prior systemic anti-neoplastic therapy, including investigational agents, within 4 weeks prior to NBTXR3 injection
  • Patient must not have received prior therapy with a checkpoint inhibitor (e.g., anti-CTLA-4, anti-PD-1/L1, and/or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways) within two weeks prior to NBTXR3 injection

Close

NRG-BR007

A Phase III Clinical Trial Evaluating De-Escalation of Breast Radiation for Conservative Treatment of Stage I, Hormone Sensitive, HER2-Negative, Oncotype Recurrence Score ≤ 18 Breast Cancer (DEBRA trial) (NCT 04852887).

Physician & Study Coordinator

Study Coordinator

Helen McGunnigle
email: Helen.McGunnigle@sluhn.org
phone: 484-658-5044

Close

Synopsis

This study is being conducted to evaluate whether treatment with surgery and hormonal therapy for low-risk Stage I hormone sensitive, HER2-negative, breast cancer is as good as the usual treatment of surgery, radiation and hormonal therapy. In this study all participants must will take hormonal therapy for 5 years, some will receive radiation therapy in addition to the hormonal therapy.

Close

Eligibility Criteria
  • Stage I, pT1N0M0 (≤ 2cm), HER2-negative, ER and/or PgR- positive breast cancer
  • Unilateral invasive adenocarcinoma of the breast on histologic examination
  • Patients must have undergone a lumpectomy and the margins must be histologically free of invasive tumor and DCIS (mastectomy is not allowed)
  • Oncotype-DX recurrence score ≤ 18
  • Patients with a T1a tumor (≤ 0.5 cm) do not have an Oncotype DX recurrence score previously documented, a tissue sample will be sent to the central lab for results prior to randomization
  • Interval between last surgery for breast cancer and study entry must be no more than 70 days
  • Bilateral mammogram or MRI required within 6 months prior to study entry
  • Patients must be intending to take endocrine therapy for a minimum of 5 years (tamoxifen or AI), but CANNOT start endocrine therapy until AFTER enrollment on study

Close