At a glance
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Adjuvant Treatment for High-risk Triple Negative Breast Cancer Patients With the Anti-PD-l1 Antibody Avelumab: A Phase III Randomized Trial. Sponsor: Dipartimento di Scienze Chirurgiche, Oncologiche e Gastroenterologiche, Università di Padova
In Brief
A Phase 3 clinical trial evaluating MSB0010718C for Triple Negative Breast Neoplasms. Completed, enrolled 474 participants across 70 sites in 2 countries.
Detailed Summary
Phase III randomized trial of the anti-PD-L1 antibody avelumab as adjuvant or post-neoadjuvant treatment for high-risk triple negative breast cancer patients. The overall protocol-defined patient population will include the following two strata of patients: * Stratum A - Patients who have completed treatment with curative intent including surgery of the primary tumor followed by adjuvant chemotherapy . * Stratum B - Patients who have completed treatment with curative intent including neoadjuvant chemotherapy followed by surgery of the primary tumor and (if indicated) further adjuvant chemotherapy.
Study Details
Timeline
Interventions
MSB0010718C-Avelumab is formulated as vials of 200 mg strength for IV administration