E-Newsletter - September 2022
Spotlight on Alliance Trials


October is National Breast Cancer Awareness Month. According to the National Cancer Instiute, breast cancer is the second most common cancer in women after skin cancer. This year in the U.S., an estimated 287,500 new cases of breast cancer will be diagnosed in women, and an estimated 43,550 women will die from breast cancer. Although rare, men get breast cancer too, and this year, in the U.S., an estimated 2,710 men will be diagnosed with breast cancer and about 530 men will die from breast cancer. It is also estimated that this year, about 30% of all new women cancer diagnoses will be breast cancer. Sixty-five percent of breast cancer cases are diagnosed at a stage where there is no sign that the cancer has spread outside of the breast, for which the 5-year relative survival rate is 99%. What's more, there are more than 3.8 million breast cancer survivors in the U.S. Mammograms can detect breast cancer early, possibly before it has spread.

Currently, Alliance has five active trials in its portfolio that have a focus on breast cancer.

  • A011801 (COMPASS HER2 RD/Breast Cancer)
  • A071701 (Genomically-guided Treatment in Brain Metastases)
  • A191901 (Optimizing Endocrine Therapy)
  • A221803 (Reducing Radiation Dermatitis)
  • A231910CD (Patient-centered Communication in Breast Cancer)

Alliance A011801 (COMPASS HER2 RD/Breast Cancer)

Ciara C. O'Sullivan, MB, BCh, BAO, of the Mayo Clinic, leads 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). 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 Member Site

Alliance A071701 (Genomically-guided Treatment in Brain Metastases)

Priscilla Brastianos, MD,
of Massachusetts General Hospital, leads Alliance A071701 (Genomically-guided treatment trial in brain metastases). This phase II 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 Augusst 15, 2019. Learn more: http://bit.ly/AllianceA071701 | Alliance Member Site

Alliance A191901 (Optimizing Endocrine Therapy)

Katherine E. Reeder-Hayes, MD, MBA, MSc, of University of North Carolina at Chapel Hill, leads Alliance A191901 (Optimizing endocrine therapy through motivational interviewing and text interventions). This phase III 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 Member Site

Alliance A221803 (Reducing Radiation Dermatitis)

Kimberly Corbin, MD, of the Mayo Clinic, leads Alliance A221803 (Mepitel film for the reduction of radiation dermatitis in breast cancer patients undergoing post-mastectomy radiation therapy: A randomized phase III clinical trial). This phase III trial studies how well Mepitel film works in reducing radiation dermatitis (redness and peeling) in patients with breast cancer during radiation therapy after a mastectomy. Mepitel film may reduce the severity of skin redness and peeling in the area of radiation. The trial opened on June 15, 2022. Learn more: https://bit.ly/AllianceA221803 | Alliance Member Site

Alliance A231901CD (Patient-centered Communication in Breast Cancer)

Sarah T. Hawley, PhD, MPH, of University of Michigan School of Medicine and Public Health, leads Alliance A231901CD (Improving patient-centered communication in breast cancer: A RCT of a shared decision engagement system (ShaRES). 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 Member Site



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