Overview of Ductal Carcinoma In Situ (DCIS) and the ongoing Phase 2 RECAST DCIS study investigating (Z)-endoxifen as a potential treatment.
DCIS is considered the earliest form of breast cancer and is usually found during a mammogram done as part of breast cancer screening or to investigate a breast lump. It is noninvasive, meaning it hasn’t spread out of the milk duct, and has a low risk of becoming invasive. Current standard of care includes surgery, radiation therapy, and/or hormone therapy. Approximately 60,000 DCIS diagnoses are made each year in the United States alone.
The RECAST DCIS trial is sponsored and operated by Quantum Leap Healthcare Collaborative, which was established in 2005 as a collaboration between medical researchers at University of California, San Francisco and Silicon Valley entrepreneurs. Participants in the study will be treated with up to six months of endocrine therapy with the intent to forego surgery and instead be monitored via long-term active surveillance, if appropriate. A key element in reducing overtreatment of DCIS is identifying biomarkers that reflect the risk of progression so that those with low-risk lesions are spared surgery. RECAST DCIS features the assessment of imaging and molecular-based biomarkers in addition to evaluating new investigational agents in this setting. The (Z)-endoxifen study arm expected to enroll up to 110 patients.
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