Quantum Leap Healthcare Collaborative Initiates Landmark Phase 2 RECAST DCIS Platform Trial to Evaluate Alternative DCIS Treatments with Atossa Therapeutics, Havah Therapeutics, and the Menarini Group
October 30, 2023 at 10:30 pm IST
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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.
Atossa Therapeutics, Inc. is a clinical-stage biopharmaceutical company. It is engaged in developing medicines in areas of significant unmet medical need in oncology with a focus on using (Z)-endoxifen to prevent and treat breast cancer. Its lead drug candidate under development is oral (Z)-endoxifen, which it is developing for both the prevention and treatment of breast cancer. (Z)-endoxifen is the potent Selective Estrogen Receptor Modulator for estrogen receptor inhibition and causes estrogen receptor degradation. In addition to its potent anti-estrogen effects, (Z)-endoxifen has been shown to target PKCB1, a known oncogenic protein, at clinically attainable blood concentrations. It is developing a form of (Z)-endoxifen which is administered orally for the potential treatment of breast cancer and reduction of breast density. It has completed four Phase I clinical studies and two Phase II clinical studies with its proprietary (Z)-endoxifen (including oral and topical formulations).
Quantum Leap Healthcare Collaborative Initiates Landmark Phase 2 RECAST DCIS Platform Trial to Evaluate Alternative DCIS Treatments with Atossa Therapeutics, Havah Therapeutics, and the Menarini Group