E-News - October 2021
Spotlight on Alliance Breast Cancer Trials
 

ACTIVE ALLIANCE BReAST CANCER TRIALS

For National Breast Cancer Awareness Month (#NBCAM), Alliance will feature trials specifically for patients with breast cancer and helpful resources. Up first, take a look at eight trials that are active and currently enrolling participants:

Alliance A221702 (Axillary Reverse Mapping: A prospective trial to study rates of lymphedema and regional recurrence after sentinel lymph node biopsy and sentinel lymph node biopsy followed by axillary lymph node dissection with and without axillary reverse mapping (ARM)) is being led by V. Suzanne Klimberg, MD, PhD (University of Texas Medical Branch at Galveston). This phase III Alliance trial looks at how well axillary reverse mapping works in preventing lymphedema in patients with breast cancer undergoing axillary lymph node dissection. Axillary reverse mapping may help to preserve the lymph node drainage system around the breast so as to prevent lymphedema after surgery. The trial opened on May 31, 2019. Learn more: http://bit.ly/AllianceA221702

Alliance A071701 (Genomically-guided treatment trial in brain metastases) is being led by Priscilla Brastianos, MD (Massachusetts General Hospital). This phase II Alliance trial looks at how well genetic testing works in guiding treatment for patients with solid tumors that have spread to the brain. Several genes have been found to be altered or mutated in brain metastases such as NTRK, ROS1, CDK, or PI3K. Medications that target these genes such as abemaciclib, GDC-0084, and entrectinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Genetic testing may help doctors tailor treatment for each mutation. The trial opened on August 15, 2019. Learn more: http://bit.ly/AllianceA071701

Alliance A191901 (Optimizing endocrine therapy through motivational interviewing and text interventions) is being led by Katherine E. Reeder-Hayes, MD, MBA, MSc (University of North Carolina at Chapel Hill). This phase III Alliance trial compares an additional support program, using text message reminders and/or telephone-based counseling, with usual care in making sure patients with breast cancer take their endocrine therapy medication as prescribed. Poor medication adherence has been shown to be a serious barrier to effective treatment for patients with breast cancer that is hormone receptor-positive. Adding text message reminders and/or telephone-based counseling to usual care may increase the number of days that patients take their endocrine therapy medication as prescribed. The trial opened on December 10, 2020. Learn more: https://bit.ly/Alliance-A191901

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 compared with T-DM1 and tucatinib) is being led by Ciara C. O'Sullivan, MB, BCh, BAO (Mayo Clinic). 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. The trial opened on January 6, 2021. Learn more: https://bit.ly/Alliance-A011801

Alliance A211102 (Testing for atypia in random periareolar fine needle aspiration (RPFNA) cytology after 12 months metformin (1,1-dimethyl biguanide hydrochloride) chemoprevention versus placebo control in premenopausal women) is being led by Victoria L. Seewaldt, MD (City of Hope). This randomized phase III trial studies metformin hydrochloride to see how well it works compared to placebo in preventing breast cancer in patients with atypical hyperplasia or in situ breast cancer. Chemoprevention is the use of certain drugs to keep cancer from forming. The use of metformin hydrochloride may prevent breast cancer. The trial opened on February 1, 2015. Learn more: https://bit.ly/Alliance-A211102

Alliance A211601 (Evaluation of mammographic breast density effect of aspirin: A companion to Alliance study A011502) is being led by Marie E. Wood, MD (University of Vermont Health Network). This phase III trial evaluates mammographic breast density in participants with hormone receptor-negative breast cancer enrolled on study A011502. High breast density has been shown to be a strong risk factor for developing breast cancer and decreasing breast density may decrease the risk for breast cancer. Participants treated with aspirin may show reduced breast density on a mammogram. The trial opened on August 1, 2018. Learn more: https://bit.ly/Alliance-A211601

Alliance A231901CD (Improving patient-centered communication in breast cancer: A RCT of a shared decision engagement system (ShaRES)) is being led by Sarah T. Hawley, PhD, MPH (University of Michigan School of Medicine and Public Health). This trial studies the effectiveness of two interventions on patient-reported outcomes of patient-centered communication and decision-making about breast cancer treatment. The first intervention consists of enhancements to an existing patient-facing breast cancer treatment decision tool called iCanDecide that supports the management of worry, distress, and anxiety as compared to an existing tool. The second intervention consists of a clinician dashboard that populates information after patients view either website regarding any ongoing issues or concerns. The trial opened on January 15, 2021. Learn more: https://bit.ly/Alliance-A231901CD

Alliance A011202 (A randomized phase III trial comparing axillary lymph node dissection to axillary radiation in breast cancer patients (cT1-3 N1) who have positive sentinel lymph node disease after neoadjuvant chemotherapy) is being led by Judy Boughey, MD (Mayo Clinic). This randomized phase III trial studies lymph node dissection and radiation therapy to see how well it works compared to radiation therapy alone in treating patients with breast cancer previously treated with chemotherapy and surgery. Lymph node dissection may remove cancer cells that have spread to nearby lymph nodes in patients with breast cancer. Radiation therapy uses high-energy x rays or protons to kill tumor cells. It is not yet known if radiation therapy works better alone or with lymph node dissection in treating patients with breast cancer previously treated with chemotherapy and surgery. The trial opened on February 7, 2014. Learn more: https://bit.ly/Alliance-A011202