Alliance A011801

The CompassHER2 trials (COMprehensive use of Pathologic Response ASSessment to optimize therapy in HER2-positive breast cancer): CompassHER2 Residual Disease (RD), a double-blinded, phase III randomized trial of T-DM1 and placebo compared with T-DM1 and tucatinib.

This phase III trial studies how well trastuzumab emtansine (T-DM1) and tucatinib work in preventing breast cancer from coming back (relapsing) in patients with high risk, HER2 positive breast cancer. T-DM1 is a monoclonal antibody, called trastuzumab, linked to a chemotherapy drug, called DM1. Trastuzumab is a form of targeted therapy because it attaches to specific molecules (receptors) on the surface of cancer cells, known as HER2 receptors, and delivers DM1 to kill them. Tucatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving T-DM1 and tucatinib may work better in preventing breast cancer from relapsing in patients with HER2 positive breast cancer compared to T-DM1 alone.

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Principle Investigator: Priya Gor, MD

Alliance A191901

Optimizing Endocrine Therapy Through Motivational Interviewing and Text Interventions

Patients are asked to take part in this research study because their doctor has prescribed taking an endocrine therapy (ET) medication daily by mouth as part of their treatment for hormone receptor positive breast cancer. ET medication is also called hormone therapy and it is used to slow or stop the growth of hormone receptor positive breast cancer cells.
We are doing this study because we want to find out if using either text message reminders or telephone-based counseling, or both is better or worse than the usual approach for making sure that women take their ET medication as prescribed. This is also called medication adherence.

Medication adherence is how well patients take the medication as prescribed by their doctors and good medical adherence is when patients take medications correctly. Poor medication adherence has been shown to be a serious barrier to effective treatment for hormone receptor positive breast cancer patients.

The usual approach is defined as the medical care most people get while taking ET medication, including regular follow-up appointments and advice from their medical care providers while taking the medication.

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Principle Investigator: Priya Gor, M.D.

IRB-2021-04

Pilot Study to evaluate the Impact of a Home-Based Exercise Program on Cancer-Related Fatigue in Breast Cancer Patients Undergoing Curative-Intent Chemotherapy

Patients are being asked to take part in this study because they have breast cancer and are undergoing curative-intent chemotherapy.

This study will examine the feasibility of home-based exercises in reducing cancer-related fatigue in breast cancer patients who are receiving curative-intent chemotherapy treatment. The results of participants who are evaluated by a physical therapist and provided with exercises to do at home will be compared with a group of participants who have not be instructed about an exercise program to do at home.
The purpose of the study is to determine the feasibility of a specific home-based exercise program in reducing cancer-related fatigue in breast cancer patients undergoing curative-intent chemotherapy. The results of this study will be measured by responses to a survey designed to assess feelings of fatigue and other symptoms.

Principle Investigator: Priya Gor, M.D.

NRG-BR009

NRG-BR009, A Phase III Adjuvant Trial Evaluating the Addition of Adjuvant Chemotherapy to Ovarian Function Suppression plus Endocrine Therapy in Premenopausal Patients with pN0-1, ER-Positive/HER2-Negative Breast Cancer and an Oncotype Recurrence Score = 25 (OFSET)

This Phase III Trial will determine whether adjuvant chemotherapy (ACT) added to ovarian function suppression (OFS) plus endocrine therapy (ET) is superior to OFS plus ET in improving invasive breast cancer-free survival (IBCFS) among premenopausal, early- stage breast cancer (EBC) patients with estrogen receptor (ER)-positive, HER2-negative tumors and 21-gene recurrence score (RS) between 16-25 (for pN0 patients) and 0-25 (for pN1 patients).

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Principle Investigator: Priya Gor, MD

Contacts for Participation in Clinical Trials:

Virtua Samson Cancer Center
Theresa Carducci, MSN, RN, BA, CCRP
Protocol Coordinator, Cancer Registry & Research
(856) 206-4721
tcarducc@virtua.org

Virtua Voorhees
Maria Jenkins, CCRP
Clinical Research Coordinator
(856) 247-7396
mdjenkins@virtua.org

Barbara Dillon, MSN, RN
Clinical Research Nurse
(856) 247-7395
bdillon@virtua.org