Journal article

Pertuzumab, trastuzumab, and docetaxel for HER2-positive metastatic breast cancer (CLEOPATRA): end-of-study results from a double-blind, randomised, placebo-controlled, phase 3 study

Sandra M Swain, David Miles, Sung-Bae Kim, Young-Hyuck Im, Seock-Ah Im, Vladimir Semiglazov, Eva Ciruelos, Andreas Schneeweiss, Sherene Loi, Estefania Monturus, Emma Clark, Adam Knott, Eleonora Restuccia, Mark C Benyunes, Javier Cortes

The Lancet Oncology | ELSEVIER SCIENCE INC | Published : 2020


BACKGROUND: CLEOPATRA was a phase 3 study comparing the efficacy and safety of pertuzumab, trastuzumab, and docetaxel with placebo, trastuzumab, and docetaxel in patients with HER2-positive metastatic breast cancer. In the primary analysis and subsequent reports, progression-free and overall survival were significantly improved in the pertuzumab group compared with the placebo group. Here, we report the end-of-study analysis of CLEOPATRA. METHODS: This was a double-blind, randomised, placebo-controlled, phase 3 trial that was done at 204 centres in 25 countries. Eligible patients were 18 years or older, had HER2-positive, metastatic breast cancer, had not received previous chemotherapy or bi..

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Funding Acknowledgements

F Hoffmann-La Roche and Genentech.Funding for this analysis was provided by F Hoffmann-La Roche and Genentech. We thank all the patients who participated in the trial, and their families, the investigators, clinicians, and research staff at the 204 centres in 25 countries. We would also like to thank Robert Salgado for his contribution to this study. Support for third-party writing assistance for this manuscript, provided by Daniel Clyde (Health Interactions), was provided by F Hoffmann-La Roche.