ESMO 2020: Adding Atezolizumab to Chemotherapy Under Study in Triple-Negative Breast Cancer
Posted: Thursday, October 8, 2020
Sibylle Loibl, MD, PhD, of the German Breast Group Forschungs GmbH, Neu-Isenburg, and colleagues proposed the phase III GeparDouze trial to assess the safety and efficacy of adding the antineoplastic agent atezolizumab to neoadjuvant chemotherapy and adjuvant therapy in patients with early triple-negative breast cancer. The trial design was presented during the European Society for Medical Oncology (ESMO) Virtual Congress 2020 (Abstract 248TiP).
“Triple-negative breast cancer is associated with higher percentages of pathologic complete response to neoadjuvant chemotherapy, and patients with a pathologic complete response have a favorable prognosis,” the investigators commented. “Primary results have demonstrated clinically relevant efficacy and an acceptable safety profile of therapeutic blockade of PD-L1 binding by atezolizumab in patients with metastatic triple-negative breast cancer.”
The investigators plan to enroll 1,520 patients with centrally confirmed early triple-negative breast cancer and PD-L1 status. They will be randomly assigned in a 1:1 ratio to receive either 1,200 mg of intravenous atezolizumab or a placebo every 3 weeks; paclitaxel plus carboplatin will be administered concurrently. The patients will subsequently receive cyclophosphamide with either doxorubicin (AC) or epirubicin (EC) every 2 or 3 weeks. After surgery, the experimental or placebo treatment will resume for 6 months; radiotherapy may be co-administered.
Patients will be stratified based on tumor size, group, EC/AC schedule, nodal status, and PD-L1 status. The investigators identified pathologic complete response and event-free survival as the co-primary endpoints. Overall survival, recurrence-free interval, distant disease-free survival, and toxicity will be evaluated as secondary endpoints.
Disclosure: For full disclosures of the study authors, visit oncologypro.esmo.org.