A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer
A Randomized, 3 Arm, Multicenter, Phase III Study to Evaluate the Efficacy and the Safety of T-DM1 Combined With Pertuzumab or T-DM1 Combined With Pertuzumab-Placebo (Blinded for Pertuzumab), Versus the Combination of Trastuzumab Plus Taxane, as First Line Treatment in HER2 Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer
This randomized, 3-arm, multicenter, phase III study will evaluate the efficacy and safety of trastuzumab emtansine (T-DM1) with pertuzumab or trastuzumab emtansine (T-DM1) with pertuzumab-placebo (blinded for pertuzumab), versus the combination of trastuzumab (Herceptin) plus taxane (docetaxel or paclitaxel) in participants with HER2-positive progressive or recurrent locally advanced or previously untreated metastatic breast cancer. Participants will be randomized to 1 of 3 treatment arms (Arms A, B or C). Arm A will be open-label, whereas Arms B and C will be blinded.
Inclusion Criteria:
Exclusion Criteria:
Little Rock, Arkansas 72204, United States
Miami, Florida 33136, United States
Annapolis, Maryland 21401, United States
St Louis, Missouri 63141, United States
Amarillo, Texas 79106, United States
Houston, Texas 77030, United States
Vienna, 1090, Austria
Essen, 45136, Germany
Halle, 06120, Germany
Heidelberg, 69120, Germany
Mainz, 55131, Germany
Minden, 32429, Germany
Meldola, Emilia-Romagna 47014, Italy
Udine, Friuli Venezia Giulia 33100, Italy
Perugia, Umbria 06156, Italy
Ehime, 791-0280, Japan
Hokkaido, 003-0804, Japan
Kuala Lumpur, FED. Territory of Kuala Lumpur 59100, Malaysia
Petaling Jaya, Selangor, Selangor 46050, Malaysia
Auckland, 1023, New Zealand
Arequipa, 04001, Peru
Moscow, Moscow Oblast 143423, Russia
Moskva, Moscow Oblast 115478, Russia
Pyatigorsk, Stavropol Kray 357502, Russia
Kazan', Tatarstan Republic 420029, Russia
Stavropol, 355045, Russia
Gyeonggi-do, 463-707, South Korea
Seoul, 03080, South Korea
Seoul, 138-736, South Korea
Santiago de Compostela, LA Coruña 15706, Spain
A Coruña, 15006, Spain
Jaén, 23007, Spain
Malmö, 200 25, Sweden
Adana, 01230, Turkey (Türkiye)
Cornwall, TR1 3LQ, United Kingdom
Glasgow, G12 0YN, United Kingdom
Stoke-on-Trent, ST4 6QG, United Kingdom