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
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
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
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 Registry is keeping track of people who are undergoing therapy for ductal carcinoma in situ (DCIS) and who are having molecular testing. This type of molecular testing looks at how certain genes are used by tumor cells. The goal of this Registry is to help researchers understand the value of molecular testing in the choice of therapy for DCIS patients. This Registry will eventually contain information from thousands of people who are undergoing DCIS treatment and may result in a future change in disease treatment and improvement of care for people with DCIS.
Your doctor will determine whether this clinical trial is an appropriate option for you. Some key eligibility criteria are as follows:
- Patients must be between 30 and 85 years old with histologically confirmed ductal carcinoma in situ (DCIS) in a single breast within 120 days of study consent
- Patients must have the DCISionRT test ordered during routine patient care
- Patients must be eligible for or have recently completed breast conserving surgery
- Patients must be eligible to receive radiation and/or systemic treatment
- Patients must not have evidence of invasive breast cancer in the ipsilateral or contralateral breast
- Patients must not have been surgically treated with an ipsilateral mastectomy for primary DCIS
- Patients may not have had prior systemic endocrine or chemotherapy prior to testing
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
