S1207 An Upcoming Trial for High-Risk Breast Cancer - SWOG

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4/22/2013 S1207 Clinical Trial Design • SWOG/NSABP randomized phase III double-blind, placebo-controlled clinical trial • Parallel randomization design with equal allocation to two treatment groups (everolimus vs. placebo) • Patients stratified by risk group S1207 Clinical Trial Design Adjuvant/ Neoadjuvant Chemotherapy Surgery Radiation Therapy Registration Randomization Everolimus for 1 year + Appropriate endocrine therapy for 5 years Placebo for 1 year + Appropriate endocrine therapy for 5 years S1207 Key Eligibility Criteria • Histologically confirmed HR+, HER2-negative breast cancer • Patient must complete chemotherapy before registration (within past 21 weeks) • When RT is indicated, patient must complete radiation therapy before registration (at least 21 days before and recovered to ≤ grade 1 from XRT effects) • Patient may have started endocrine therapy before registration 6
4/22/2013 S1207: 4 High-Risk Groups 1. Node-negative, primary tumor ≥ 2cm, OncotypeDX RS > 25, and completed adjuvant chemotherapy 2. 1-3 positive nodes, RS > 25, and completed adjuvant chemotherapy • RS screened via S1007 RxPONDER or otherwise 3. ≥ 4 positive nodes and completed adjuvant chemotherapy 4. ≥ 4 positive nodes and completed neoadjuvant chemotherapy S1207 Treatment Plan Patients randomized to either: • Everolimus 10mg/PO daily for one year + adjuvant endocrine therapy (selected by treating physician) OR • Matched placebo daily for one year + adjuvant endocrine therapy (selected by treating physician) S1207 Schema HR-positive and HER2-negative breast cancer Neoadjuvant chemotherapy Surgery: Number of positive nodes? Surgery Node-negative & tumor > 2 cm 1 - 3 positive > 4 positive > 4 positive lymph nodes Recurrence Score evaluation by OncotypeDX RS < 25: Not eligible RS > 25 Adjuvant Chemotherapy (may be eligible for S1007 RxPONDER if 1-3 positive nodes) Radiation therapy if indicated RANDOMIZATION Stratification factors: • Node negative • 1 - 3 positive nodes • > 4 positive nodes Adjuvant • > 4 positive nodes Neoadjuvant Everolimus for 1 year + endocrine therapy for 5 years Placebo for 1 year + endocrine therapy for 5 years 7
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S1207 An Upcoming Trial for High-Risk Breast Cancer - SWOG

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