A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
A Phase III, Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy and Safety of Pertuzumab + Trastuzumab + Docetaxel vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-Positive Metastatic Breast Cancer
This study was a Phase III, randomized, double-blind, placebo-controlled, multicenter international clinical trial conducted to investigate the use of pertuzumab in combination with trastuzumab and docetaxel as first-line treatment for participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer (MBC). Participants could have received one prior hormonal treatment for MBC. Participants may have received systemic breast cancer treatment in the neo-adjuvant or adjuvant setting, provided that the participant had experienced a disease-free interval (DFI) of greater than or equal to (≥)12 months from completion of adjuvant systemic treatment (excluding hormonal therapy) to metastatic diagnosis. Participants may have received trastuzumab and/or a taxane during the neo-adjuvant or adjuvant treatment.
Participants were randomized in 1:1 ratio to receive either pertuzumab or placebo, along with trastuzumab and docetaxel once every 3 weeks (q3w), during the treatment phase of the study until investigator-assessed radiographic or clinical progressive disease, unmanageable toxicity, or study termination. Participants in the Placebo arm were not allowed to receive open-label pertuzumab after discontinuation from study treatment. However, if any analysis of overall survival had met the predefined criteria for statistical significance, participants in the Placebo arm still on treatment were offered the option to receive open-label pertuzumab in addition to other study medications.
Inclusion Criteria:
Exclusion Criteria:
Whittier, California 90603, United States
Washington D.C., District of Columbia 20007, United States
Fort Myers, Florida 33901-8101, United States
Gainesville, Georgia 30501, United States
Marietta, Georgia 30060, United States
Lincoln, Nebraska 68510, United States
Newtown Square, Pennsylvania 19073, United States
Knoxville, Tennessee 37920, United States
Caba, 1405, Argentina
Chaco-resistencia, 3400, Argentina
Rio de Janeiro, Rio de Janeiro 21941-590, Brazil
Santo André, São Paulo 09060-650, Brazil
São Paulo, São Paulo 01221-020, Brazil
São Paulo, São Paulo 03102-002, Brazil
Berlin, 14195, Germany
Bielefeld, 33604, Germany
Halle, 06120, Germany
Heidelberg, 69120, Germany
Mainz, 55131, Germany
Würselen, 52146, Germany
Meldola, Emilia-Romagna 47014, Italy
Ehime, 791-0280, Japan
Gunma, 371-8511, Japan
Kanagawa, 216-8511, Japan
Lublin, 20-081, Poland
Szczecin, 71-730, Poland
Warsaw, 02-781, Poland
Saint Petersburg, Sankt-Peterburg 197758, Russia
Moscow, 115478, Russia
Singapore, 119228, Singapore
Seoul, 03080, South Korea
Seoul, 120-752, South Korea
Seoul, 138-736, South Korea
San Cristóbal de La Laguna, Tenerife 38320, Spain
A Coruña, 15006, Spain
Jaén, 23007, Spain
Westcliffe-on-sea, SS0 0RY, United Kingdom