Quantum Leap Healthcare Collaborative (QLHC) announced the enrollment launch for the Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS), a Phase 2 platform study aimed at preventing the progression of DCIS to breast cancer. The study is evaluating three investigational endocrine therapy arms: (Z)-endoxifen, a selective estrogen receptor modulator (SERM) in development by Atossa Therapeutics; HAVAH T+Ai?, a proprietary combination of testosterone (T) and anastrozole (Ai) that targets the androgen and estrogen receptor pathways in development by Havah Therapeutics; and ORSERDU® (elacestrant), the only FDA approved oral selective estrogen receptor degrader (oSERD) in development by Stemline Therapeutics Inc. (Stemline), a wholly-owned subsidiary of the Menarini Group. Surgery is the current standard treatment for DCIS even though many patients never progress to breast cancer,
which means that patients are often over-treated with invasive procedures. This new trial, sponsored and
operated by QLHC, offers DCIS patients 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 study is open to enrollment with each
investigational agent arm expected to enroll up to 110 patients.