Quantum Leap Healthcare Collaborative (QLHC) has launched a groundbreaking clinical trial called Re-Evaluating Conditions for Active Surveillance Suitability as Treatment: Ductal Carcinoma In Situ (RECAST DCIS) that aims to revolutionize the treatment of ductal carcinoma in situ (DCIS) and reduce unnecessary surgeries. The trial will enroll over 300 patients across 40 sites in the United States and evaluate three investigational endocrine therapy arms.
DCIS is the earliest, noninvasive stage of breast cancer, and the current standard treatment involves surgery. However, many patients with DCIS never progress to invasive breast cancer, resulting in over-treatment with invasive procedures. The goal of the RECAST DCIS trial is to provide DCIS patients with up to six months of endocrine therapy, allowing them to avoid surgery and instead be monitored through long-term active surveillance.
The trial will evaluate three investigational agents: (Z)-endoxifen, a selective estrogen receptor modulator (SERM) developed by Atossa Therapeutics; HAVAH T+Ai™, a proprietary combination of testosterone and anastrozole developed by Havah Therapeutics; and ORSERDU® (elacestrant), an oral selective estrogen receptor degrader (oSERD) developed by Stemline Therapeutics.
By identifying biomarkers that reflect the risk of progression, the trial aims to reduce overtreatment of DCIS. Biomarkers will be assessed through imaging and molecular analysis. Each investigational agent arm is expected to enroll up to 110 patients.
The collaboration between Atossa Therapeutics, Havah Therapeutics, and Stemline brings together innovative companies working towards finding alternative treatment solutions for DCIS patients. Atossa’s (Z)-endoxifen aims to mitigate breast cancer risk, reduce cancer cell activity, and prevent recurrence. Havah’s HAVAH T+Ai™ combines testosterone and anastrozole to modulate abnormal breast tissue growth, while Stemline’s Elacestrant (ORSERDU) has already been approved for the treatment of advanced or metastatic breast cancer.
This trial represents a significant step towards personalized medicine for DCIS patients. Through the evaluation of different investigational agents and the identification of biomarkers, the goal is to provide targeted and effective treatment options that reduce unnecessary surgeries and improve outcomes for patients.
What is DCIS?
DCIS, or ductal carcinoma in situ, is the earliest stage of breast cancer where abnormal cells are found in the lining of the breast milk ducts. It is a noninvasive form of the disease.
How is DCIS currently treated?
The current standard treatment for DCIS is surgery, which often involves removing either the entire breast (mastectomy) or the cancerous portion (lumpectomy) followed by radiation therapy.
What is the goal of the RECAST DCIS trial?
The RECAST DCIS trial aims to evaluate alternative treatment approaches for DCIS by providing patients with up to six months of endocrine therapy instead of surgery. The goal is to reduce unnecessary surgeries and improve outcomes for patients.
How many patients will be enrolled in the trial?
The trial plans to enroll more than 300 patients across 40 sites in the United States. Each investigational agent arm is expected to enroll up to 110 patients.
What investigational agents will be evaluated in the trial?
The trial will evaluate three investigational agents: (Z)-endoxifen, HAVAH T+Ai™, and ORSERDU® (elacestrant). These agents aim to target different pathways involved in the progression of DCIS and prevent the development of invasive breast cancer.
– Quantum Leap Healthcare Collaborative: [https://www.quantumleaphealth.org/](https://www.quantumleaphealth.org/)
– Atossa Therapeutics: [https://www.atossatherapeutics.com/](https://www.atossatherapeutics.com/)
– Havah Therapeutics: [https://www.havahtx.com/](https://www.havahtx.com/)
– Stemline Therapeutics Inc.: [https://www.stemline.com/](https://www.stemline.com/)