1. IMpassion132 Phase III trial: atezolizumab and chemotherapy in early relapsing metastatic triple-negative breast cancer
- Author
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Miguel Martin, Sherko Kümmel, Rebecca Dent, A. Goncalves, Javier Cortes, Florian Schuetz, Sandra M. Swain, Erika Pollex, Valerie Easton, Fabrice Andre, Peter Schmid, and Regula Deurloo
- Subjects
Adult ,0301 basic medicine ,Oncology ,Cancer Research ,medicine.medical_specialty ,Anthracycline ,Triple Negative Breast Neoplasms ,Antibodies, Monoclonal, Humanized ,Deoxycytidine ,B7-H1 Antigen ,Carboplatin ,Placebos ,Capecitabine ,03 medical and health sciences ,chemistry.chemical_compound ,0302 clinical medicine ,Breast cancer ,Atezolizumab ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,medicine ,Humans ,Multicenter Studies as Topic ,Mastectomy ,Triple-negative breast cancer ,Randomized Controlled Trials as Topic ,Taxane ,business.industry ,General Medicine ,medicine.disease ,Gemcitabine ,Treatment Outcome ,030104 developmental biology ,Clinical Trials, Phase III as Topic ,chemistry ,Chemotherapy, Adjuvant ,030220 oncology & carcinogenesis ,Female ,Neoplasm Recurrence, Local ,business ,medicine.drug - Abstract
The PD-L1 inhibitor atezolizumab received US FDA accelerated approval as treatment for PD-L1-positive metastatic triple-negative breast cancer (TNBC). In IMpassion130, combining atezolizumab with first-line nab-paclitaxel for metastatic TNBC significantly improved progression-free survival and showed a clinically meaningful effect on overall survival in patients with PD-L1-positive tumors. The placebo-controlled randomized Phase III IMpassion132 (NCT03371017) trial is evaluating atezolizumab with first-line chemotherapy (capecitabine [mandatory in platinum-pretreated patients] or gemcitabine/carboplatin) for inoperable locally advanced/metastatic TNBC recurring ≤12 months after completing standard (neo)adjuvant anthracycline and taxane chemotherapy. Stratification factors are: visceral metastases, tumor immune cell PD-L1 status and selected chemotherapy. Patients are randomized to atezolizumab 1200 mg or placebo every 3 weeks with the chosen chemotherapy, continued until progression, unacceptable toxicity or withdrawal. The primary end point is overall survival.
- Published
- 2019