A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
A Randomized, Multicenter, Open-Label, Phase III Trial Comparing Trastuzumab Plus Pertuzumab Plus a Taxane Following Anthracyclines Versus Trastuzumab Emtansine Plus Pertuzumab Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer
This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of trastuzumab emtansine in combination with pertuzumab versus trastuzumab in combination with pertuzumab and a taxane as adjuvant therapy in participants with human epidermal growth (HER) factor 2 (HER2)-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, participants will receive either trastuzumab emtansine at a dose of 3.6 milligrams per kilogram (mg/kg) and pertuzumab at a dose of 420 milligrams (mg) intravenously (IV) every 3 weeks (q3w) or trastuzumab at a dose of 6 mg/kg and pertuzumab at a dose of 420 mg IV q3w in combination with a taxane.
Inclusion Criteria:
Node-positive disease (pN more than or equal to [>/=] 1), any tumor size except T0, and any hormonal receptor status; or Node-negative disease (pN0) with pathologic tumor size >2.0 centimeters by standard local assessment and negative for estrogen receptor (ER) and progesterone receptor (PR) determined by a central pathology laboratory
Exclusion Criteria:
South San Francisco, California 94080, United States
Annapolis, Maryland 21401, United States
Charlottesville, Virginia 22908, United States
South Brisbane, Queensland 4101, Australia
Newmarket, Ontario L3Y 2P9, Canada
Plérin, 22190, France
Saint-Priest-en-Jarez, 42271, France
Dresden, 01307, Germany
Hanover, 30177, Germany
Hanover, 30625, Germany
Lübeck, 23538, Germany
München, 81377, Germany
Troisdorf, 53840, Germany
Pokfulam, Hong Kong
Szeged, 6720, Hungary
Bologna, Emilia-Romagna 40138, Italy
Aviano, Friuli Venezia Giulia 33081, Italy
Ehime, 791-0280, Japan
Gunma, 371-8511, Japan
Gunma, 373-8550, Japan
Kanagawa, 216-8511, Japan
Stavanger, 4011, Norway
Lima, Lima 41, Peru
Lodz, 93-513, Poland
Otwock, 05-400, Poland
Warsaw, 02-781, Poland
Singapore, 119228, Singapore
Seoul, 03080, South Korea
San Cristóbal de La Laguna, Tenerife 38320, Spain
Phitsanuok, 65000, Thailand
Cornwall, TR1 3LQ, United Kingdom
Coventry, CV2 2DX, United Kingdom
New Castle Upon Tyne, NE7 7DN, United Kingdom
Peterborough, PE3 9GZ, United Kingdom
Portsmouth, PO6 3LY, United Kingdom
Somerset, TA1 5DA, United Kingdom
Stoke-on-Trent, ST4 6QG, United Kingdom