Alliance E-News | October 2025
Spotlight on Alliance Research

Recognizing Alliance Breast Cancer Trials During October

Approximately one in every eight women will develop breast cancer during their lifetime, making the breast cancer the most common cancer in women, according to the American Cancer Society. In 2024, more than 310,720 women and 2,790 men were diagnosed with breast cancer in the U.S., leading to the death of about 42,000 women and 500 men.

Through early detection, the five-year relative survival rate for localized cancer that hasn't spread is 91%. The relative five-year survival rate is 99% when breast cancer is diagnosed early, when treatments are localized and most effective. Survival rates drop to 86% for regional-state cancer and 32% for distant-stage disease.

The death rate from breast cancer has dropped 44% since 1989 due to early detection and advances in treatment, averting about 518,000 deaths from the disease. However, not all women have benefited equally from this progress due to lack of screening and treatments in some areas.

The Alliance is working to advance the knowledge and access of screening tools and treatments to ensure more individuals have access to the best treatments.

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

A012103 - Pembrolizumab vs. observation in people with triple-negative breast cancer who had a pathologic complete response after chemotherapy plus pembrolizumab

Led by Sara Tolaney, MD, MPH, of the Dana-Farber Cancer Institute, this phase III trial compares the effect of pembrolizumab to observation for the treatment of patients with early-stage triple-negative breast cancer who achieved a pathologic complete response after preoperative chemotherapy in combination with pembrolizumab. Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. This trial may help researchers determine if observation will result in the same risk of cancer coming back as pembrolizumab after surgery in triple-negative breast cancer patients who achieve pathologic complete response after preoperative chemotherapy with pembrolizumab.

A012301 - LoTam: A randomized, phase III clinical trial of low-dose tamoxifen for selected patients with molecular low-risk early-stage breast cancer

Led by Dean Shumway, MD, of the Mayo Clinic, this phase III trial compares the effect of low dose tamoxifen to usual hormonal therapy, including aromatase inhibitors, in treating post-menopausal women with hormone positive, HER2 negative early-stage breast cancer. Tamoxifen is in a class of medications known as antiestrogens that blocks the activity of estrogen. This may stop the growth of some breast tumors that need estrogen to grow. Aromatase inhibitors, such as anastrozole, letrozole, and exemestane, prevent the formation of estradiol, a female hormone, by interfering with an aromatase enzyme. Aromatase inhibitors are used as a type of hormone therapy to treat postmenopausal women with hormone-dependent breast cancer. Giving low dose tamoxifen may be more effective compared to usual hormone therapy in treating post-menopausal women with hormone-positive, HER2 negative early-stage breast cancer.

A012303 - ShortStop-HER2: 12 months vs. 6 months of HER2-targeted medications for people with HER2+ breast cancer who had a pathologic complete response after chemotherapy plus trastuzumab

Adrienne Waks, MD, of the Dana-Farber Cancer Center, leads this phase III trial comparing six months of human epidermal growth factor receptor 2 (HER2)-targeted therapy to 12 months of HER2-targeted therapy for the treatment of HER2-positive (+) breast cancer in patients that had a pathologic complete response (pCR) after preoperative (neoadjuvant) chemotherapy with trastuzumab. Trastuzumab and pertuzumab are monoclonal antibodies and forms of targeted therapy that attach to a receptor protein called HER2. HER2 is found on some cancer cells. When trastuzumab or pertuzumab attach to HER2, the signals that tell the cells to grow are blocked and the tumor cell may be marked for destruction by the body's immune system. Giving six months of HER2-targeted therapy may work better than giving 12 months for the treatment of HER2+ breast cancer in patients that had a pCR after neoadjuvant chemotherapy with trastuzumab.

A211901 - Reaching rural cancer survivors who smoke using text-based program

Led by Devon Noonan, PhD, MPH, of Duke University School of Medicine, this phase III trial compares the effect of text-based cessation intervention to a manual in helping rural cancer patients (including people with breast cancer) who smoke, quit. The study hypothesizes that text-based scheduled gradual reduction may reduce the frequency of cigarette use to zero and may be effective in quitting smoking.

A221801 - Testing laser therapy for treatment of vaginal dryness in survivors of breast cancer, the revitalize trial

Led by Maryam Lustberg, MD, MPH, of Yale University Comprehensive Cancer Center, this phase III trial tests whether vaginal fractional CO2 laser therapy works in treating vaginal dryness in breast cancer survivors. Vaginal dryness can be commonly experienced with normal aging, with menopause, or come about from medications used to treat breast cancer such as chemotherapy or endocrine therapies like tamoxifen or aromatase inhibitors. Vaginal fractional CO2 laser therapy may help reduce vaginal dryness.

A232301CD - Testing an enhanced digital delivery model for inherited cancer genetic testing in young adults with cancer

Angela Bradbury, MD, of the University of Pennsylvania Abramson Cancer Center, leads this phase III trial compares the use of a digital chatbot enabled intervention to standard remote genetic services for increasing uptake of genetic counseling and testing among adolescents and young adult (AYA) cancer patients. Genetic testing for cancer predisposition syndromes has become standard evidence-based practice and can inform enhanced screening and risk reducing measures to reduce cancer morbidity and mortality. Despite this, many AYAs are not receiving recommended genetic counseling and testing. Offering remote telehealth services can address access barriers and chatbots and texting interventions could enhance patient outcomes and reduce provider and staff time. The use of a digital chatbot enabled intervention may be equally as effective as standard remote genetic services in AYA cancer patients undergoing genetic testing.