Study of Hormonal Therapies and Active Surveillance for Early Breast Cancer DCIS Management

What this Trial Is About

Researchers are evaluating if active surveillance combined with hormonal therapy can effectively manage ductal cell carcinoma in situ DCIS, an early stage of breast cancer. This study aims to determine whether new endocrine therapies increase the number of patients suitable for long-term active surveillance instead of surgery, which often has significant health effects. The trial is a Phase 2 randomized study focusing on treatment options for hormone receptor-positive DCIS in women. Participants will receive one of several hormonal treatments standard or low-dose tamoxifen for premenopausal women, aromatase inhibitors for postmenopausal women, or investigational therapies including a testosterone plus anastrazole pellet, elacestrant, or z-endoxifen capsules. Treatments are taken orally or via subcutaneous pellet insertion, with dosing schedules ranging from daily oral medication to pellet insertion every three months, continuing for up to three years. Participants undergo MRI evaluations at baseline, 3 months, and 6 months, followed by alternating MRI and mammogram scans every 6 months for up to 5 years. If evaluations suggest surgery is needed, participants stop the study treatment and proceed with surgery as standard care. During the study, participants provide blood samples to assess immune status, saliva samples for genetic testing, and tissue samples from any surgery performed as part of their care. They are followed annually for 10 years to monitor outcomes. The main outcome measured is the number of patients remaining on active surveillance at 7 months. Secondary outcomes assess long-term suitability for surveillance, progression to invasive cancer, quality of life, lesion changes on imaging, adherence to surveillance, and risk predictions based on mammography over several years.

DCIS: RECAST Trial Ductal Carcinoma In Situ: Re-Evaluating Conditions for Active Surveillance Suitability as Treatment