Quality Awards
Breast Clinical Trials
Study Coordinator
Helen McGunnigle
email: Helen.McGunnigle@sluhn.org
phone: 484-658-5044
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.
- 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
Study Coordinator
Helen McGunnigle
email: Helen.McGunnigle@sluhn.org
phone: 484-658-5044
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.
- 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
The purpose of this research is to compare the effects, good or bad, of inavolisib plus fulvestrant versus alpelisib plus fulvestrant in patients with HR-positive, HER2-negative breast cancer. In this study, you will get either inavolisib plus fulvestrant or alpelisib plus fulvestrant. Your group will be decided by chance (like tossing a coin). You will have an equal chance of being placed in either group. Inavolisib is an investigational drug, which means it has not been approved for this indication. This study will enroll only patients with breast cancer with a PIK3CA mutation.
Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:
- Histologically or cytologically confirmed adenocarcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent
- Documented HR+, HER2- tumor according to American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines
- PIK3CA mutation result must be available at time of study enrollment
- Disease progression after or during treatment with a combination of CDK4/6i and endocrine therapy:
- ≤ 2 prior lines of systemic therapy in metastatic breast cancer setting
- CDK4/6i based therapy does not need to be the last one received prior study entry
- one line of chemotherapy in metastatic breast cancer setting allowed
- Participants for whom endocrine-based therapy is recommended and treatment with cytotoxic chemotherapy is not indicated at time of entry into the study, as per national or local treatment guidelines
- Patients must have measurable disease
- Patients must have an ECOG performance score of 0-2 and a life expectance of at least 6 months
- Patients must be able to swallow oral medication and not have any malabsorption syndrome or other condition that would interfere with enteral absorption
- Patients with Type 2 diabetes requiring ongoing systemic treatment at the time of study entry or any history of Type 1 diabetes are excluded
- Patients with prior treatment in locally advanced or metastatic setting with any PI3K, AKT, or mTOR inhibitor or any agent whose mechanism of action is to inhibit the PI3K/-AKT/-mTOR pathway are excluded
The purpose of this research study is to see if the medication sacituzumab govitecan in combination with pembrolizumab, a type of immunotherapy, can improve outcomes and delay return of disease in patients with high-risk early stage triple-negative breast cancer (TNBC) when compared to pembrolizumab alone or in combination with capecitabine. Patients will either receive sacituzumab govitecan and pembrolizumab or the physician’s choice of pembrolizumab alone or pembrolizumab plus capecitabine for up to eight 3-week long cycles.
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 early stage triple negative breast cancer with residual disease in the breast or lymph nodes following surgery
- Patients must have received a minimum of 6 cycles of chemotherapy (with or without an anti-PD(L)1 agent) prior to surgery
- Adequate excision and surgical removal of all clinically evident disease in the breast and/or lymph nodes
- Patients must have received appropriate radiotherapy and recovered from any treatment related side effects
- Study enrollment must occur within 16 weeks of surgery
- Patients may not have known germline BRCA mutations
- Stage IV (metastatic) disease is excluded
Physician
William Smith, MD
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.
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
Study Coordinator
Helen McGunnigle
email: Helen.McGunnigle@sluhn.org
phone: 484-658-5044
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.
- 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
The purpose of this study is to help determine if the chance of early stage breast cancer returning will be less if chemotherapy is added to hormonal therapy with an aromatase inhibitor and ovarian suppression. Patients must be premenopausal with a breast cancer that is ER-positive, HER2-negative and an Oncotype recurrence score of ≤ 25.
Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:
- Patients must be female and determined to be premenopausal (evidence of functioning ovaries) at the time of pre-study entry.
- Early stage breast cancer confirmed by histologic analysis – pT1-3, pN0-N1, Er and/or PgR- positive and HER2-negative.
- If the breast cancer is node-negative, the Oncotype DX score must be 21-25 or 1-20 with high clinical risk (low histologic grade with primary tumor size > 3 cm, intermediate histologic grade with primary tumor size > 2 cm, or high histologic grade with primary tumor > 1 cm).
- If the breast cancer has 1-3 nodes involved, the Oncotype DX score must be < 26.
- Patients with a Low Risk or MP1 MammaPrint result must have eligibility confirmed by Oncotype DX recurrence score at pre-study entry.
- MammaPrint High Risk or MP2 results are ineligible for study.
- Pre-study entry must be within 16 weeks of the last surgery for breast cancer (including re-excision of margins if applicable).
- Hormonally based contraceptive measures must be discontinued prior to pre-entry (including progestin/progesterone IUDs).
This clinical trial is being done to determine if adding an immunotherapy drug (durvalumab) to usual chemotherapy before surgery can lower the chance of breast cancer returning. This study may help determine if this approach is better, the same, or worse than the usual approach to treating hormone receptor positive, HER2 negative breast cancer. The usual approach is chemotherapy.
Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:
- Patients must have a MammaPrint test score of MP2 or between negative 0.57 and negative 1.0, including negative 0.57
- Patients must have histologically confirmed estrogen (ER) and/or progesterone (PR) positive, HER2 negative breast cancer
- Patients must have clinical stage II or III breast cancer that has not been previously treated with chemotherapy, immunotherapy, biologic or hormonal therapy
- Patients may not have locally recurrent or metastatic breast cancer
- Patients must be candidates for doxorubicin, paclitaxel and durvalumab therapy as determined by their physician
- Patients may not have active autoimmune disease or uncontrolled diabetes
- Patients must have adequate cardiac function
