Quantum Leap Health Carecollaborative

Dcis - the re-evaluating conditions for active surveillance suitability as treatment: ductal carcinoma in situ (recast dcis) platform trial is a landmark phase 2 trial that is changing the lens through which we treat dcis. The study is aimed at preventing the progression of dcis to breast cancer and is evaluating three investigational endocrine therapy arms.with the objective to avoid over-treatment of low-risk dcis patients, this new trial offers dcis patients endocrine therapy with the intent to identify patients who are responsive to non-invasive treatment and have the option to omit surgery and be monitored via long-term active surveillance. (continued on schedule o)a key element in reducing over treatment 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 mri imaging and molecular-based biomarker analyses in addition to evaluating new investigational agents in this setting. If patients and their physicians agree, they may be able to stay on endocrine therapy for up to three years. Average overhead booked to program in fy2024 = 7.2%

Phase1b - pre i-spy is an open-label phase 1b platform study designed to evaluate single agents or combinations in a metastatic treatment setting that may be relevant for breast cancer patients with the overall goal of moving promising drug regimens into the i-spy 2.2 trial and/or other oncology-based trials in a timely manner. The primary objectives of this platform trial are to determine the safety and tolerability of new agents/regimes in patients with certain advanced solid tumors and breast cancer while obtaining preliminary efficacy data of the new agents/regimes. The study was developed to help investigators and industry partners meet the safety qualifications necessary for participation in i-spy 2.2 (continued on schedule o) trial and/or other phase ii/iii studies. Average overhead booked to program in fy2024 = 7.00%

Other programs include breast cancer trials (bct) match, covid-19 trials, i-spy 2.0, endocrince optimization project (eop) trials, and one source ai.