Alliance E-News - October 2026
Alliance Trial Awareness
Breast Cancer Awareness Month: Advancing Breast Cancer Research through Clinical Trials
The Alliance for Clinical Trials in Oncology has eight active trials open to breast cancer patients and survivors
Research progress in breast cancer is saving lives, improving treatments, and offering hope to millions of people. Yet breast cancer remains a significant public health challenge, underscoring the continued need for research, earlier detection, and more effective treatment options.
Breast cancer is the most common cancer in American women, after skin cancers, accounting for about one in three new cancer diagnoses in women each year. According to the American Cancer Society, about 320,000 new cases are expected to be diagnosed in 2026.
Although breast cancer incidence rates have risen by about 1% annually in recent years, the increase has been somewhat faster among women younger than 50, about 1.4% per year. There is also encouraging news: breast cancer death rates have steadily declined since 1989, falling by a total of 44% through 2023. This progress is likely due to earlier detection through screening, greater awareness, and advances in treatment. Today, about 4 million people in the United States are living as breast cancer survivors.
Clinical trials play a vital role in building this progress. As part of the National Clinical Trials Network sponsored by the National Cancer Institute, the Alliance for Clinical Trials in Oncology works to advance cancer research and expand access to promising screening strategies and treatments. Through its clinical trials, the Alliance helps generate the evidence needed to improve care and bring better treatment options to patients.
The impact of this work extends beyond individual studies. Did you know that the Alliance has nearly 1,900 publications from its breast cancer research studies available online? Explore these findings in Alliance’s breast cancer publications collection.
We extend our deepest gratitude to the patients, their families, and the clinical investigators who contributed to these trials. Their participation, dedication, and partnership are essential to advancing medical knowledge and informing future treatment options for people with breast cancer worldwide.
Today, the Alliance and Alliance Foundation Trials (AFT) have eight active trials open to people with breast cancer. Each represents another opportunity to advance research, improve care, and shape the future of breast cancer treatment.
Trials Focused on Breast Cancer
Alliance A012103: OptimICE-PCR: De-escalation of therapy in early-stage TNBC patients who achieve pCR after neoadjuvant chemotherapy with checkpoint inhibitor therapy
Led by Sara Tolaney, MD, MPH, of the Dana-Farber Cancer Institute, this phase III trial compares continued treatment with pembrolizumab, the current standard approach, with observation alone to determine which strategy is more effective at preventing cancer recurrence in patients with early-stage triple-negative breast cancer (TNBC) who achieve a pathologic complete response after receiving chemotherapy before surgery. The current standard of care is to continue pembrolizumab for up to 27 weeks after surgery. The study aims to determine whether observation alone may be an effective alternative for these patients. Pembrolizumab is a monoclonal antibody immunotherapy that helps the immune system recognize and attack the cancer cells and may interfere with their ability to grow and spread.
Alliance A012303: ShortStop-HER2: Shortened duration of adjuvant therapy in patients with early-stage HER2-positive breast cancer who achieve pCR after neoadjuvant chemotherapy with HER2 blockade
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 with the standard 12-month treatment course in patients with HER2-positive breast cancer in patients who achieve a pathologic complete response (pCR) after chemotherapy with trastuzumab before surgery. The study aims to determine whether six months of HER2-targeted therapy is as effective as or more effective than 12 months of treatment in these patients. Trastuzumab and pertuzumab are monoclonal antibodies that target HER2, a protein found on the surface of some cancer cells. By binding to HER2, these therapies block signals that promote cancer cell growth and may also help the immune system recognize and destroy cancer cells. Shortening this treatment to six months may reduce the burden of therapy while maintaining its effectiveness in preventing breast cancer recurrence.
Alliance A221801: The Revitalize Trial: Reducing vaginal atrophy with fractional CO2 laser for breast cancer survivors
Led by Maryam Lustberg, MD, MPH, of Yale University Comprehensive Cancer Center, this phase III trial evaluates whether vaginal fractional CO2 laser therapy is effective in reducing vaginal dryness in breast cancer survivors. Vaginal dryness is a common symptom associated with aging and menopause, but it may also result from breast cancer treatments, including chemotherapy and endocrine therapies such as tamoxifen or aromatase inhibitors. Fractional CO2 laser therapy may help relieve vaginal dryness and improve symptoms. Read the news release.
AFT-70 NAVIGATE: Novel adaptive Signatera-guided strategy with giredestrant as adjuvant therapy for ER-positive breast cancer
Led by Komal Jhaveri, MD, of Memorial Sloan Kettering Cancer Center and Gaorav Gupta, MD, PhD, of UNC Lineberger Comprehensive Cancer Center, this randomized phase III trial evaluates a novel molecular residual disease (MRD)-guided treatment strategy for patients with intermediate and high-risk ER-positive/HER2-negative early breast cancer. The study aims to determine whether outcomes can be maintained while using CDK4/6 inhibitors more selectively, rather than exposing all patients to prolonged therapy. The approach combines giredestrant, an investigational next-generation oral selective estrogen receptor degrader (SERD), with ongoing Signatera Genome MRD monitoring. By monitoring for molecular evidence of residual cancer, researchers aim to identify patients who may benefit from treatment intensification with the addition of a CDK4/6 inhibitor. Read the news release.
Alliance A222302: Distance-based exercise to preserve function and prevent disability (DEFEND)
Kathryn Schmitz, PhD, MPH, of UPMC Hillman Cancer Center and Jennifer Ligibel, MD, of Dana-Farber Cancer Institute, lead the DEFEND study that explores whether a structured exercise program delivered entirely through telehealth can help people receiving chemotherapy maintain physical function, reduce fatigue, and prevent disability. The trial highlights an important aspect of cancer care beyond treating the tumor—helping patients remain active, preserve their independence, and maintain their quality of life throughout treatment. Read the news release.
Research Focused on Prevention and Early Detection
Alliance 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 and survivors (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 helping people stop smoking.
Alliance A212102: Blinded reference set for multicancer early detection blood tests
Marie Wood, MD, of the University of Colorado School of Medicine, is leading this clinical study which collects and stores blood and tissue samples from individuals diagnosed with cancer and those without evidence of the disease to help evaluate and advance tests designed to detect multiple cancers at earlier stages. Breast cancer is among the cancers included in this research aimed at supporting the development of improved early detection methods.
Alliance A232301CD: An enhanced eHealth and chatbot-enabled delivery model for clinical genetic services in community AYA cancer patients
Angela Bradbury, MD, of the University of Pennsylvania Abramson Cancer Center, is leading this phase III trial comparing a digital chatbot-enabled intervention with standard remote genetic services to determine whether it can increase the use of genetic counseling and testing among adolescents and young adults (AYA) with cancer. Genetic testing for inherited cancer syndromes is an evidence-based standard of care that can guide enhanced screening and risk-reduction strategies to help reduce cancer-related illness and death. However, many AYAs do not receive recommended genetic counseling and testing. Remote genetic services may help overcome barriers, while chatbots and text-based interventions could further improve access, support patient engagement, and reduce demands on health care staff. The study will evaluate if a digital chatbot-enabled intervention is as effective as standard remote genetic services in increasing the uptake of genetic counseling and testing among AYAs with cancer. Read the news release.
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The Alliance for Clinical Trials in Oncology is a national leader in advancing cancer research, uniting more than 26,000 cancer specialists at 112 main institutions and 1,400 affiliates across the U.S. and Canada. As part of the National Clinical Trials Network and a leading research base for the NCI Community Oncology Research Program, the Alliance conducts pioneering, practice-changing clinical trials that improve outcomes and reshape standards of care. Our work has led to multiple FDA approvals, influenced national guidelines, and produced hundreds of high-impact publications. More than 40,000 participants have taken part in Alliance studies, and our growing biospecimen repository now includes more than 1.5 million samples, collected over the past 30 years. Learn more at AllianceforClinicalTrialsinOncology.org.
