A Study Comparing Kadcyla Plus Perjeta Treatment to Chemotherapy Combined With Herceptin Plus Perjeta in Patients With HER2-Positive Breast Cancer (NCT02131064)
In this randomized, multicenter, open-label, two-arm study, ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) plus Pertuzumab (Perjeta®; Genentech, Inc.) will be compared to chemotherapy plus trastuzumab (Herceptin®;Genentech, Inc.) plus Perjeta in the treatment of operable HER2-positive breast cancer. Patients will be randomized in a 1: 1 ratio to receive either of the following neoadjuvant treatments for a total of six 3-week cycles:
- Arm A: Docetaxel (Docefrez®; Sun Pharmaceutical Industries Ltd.) + + Herceptin + Perjeta Arm B: Kadcyla + Perjeta + Carboplatin (Paraplatin®; Bristol-Myers Squibb)
Following treatment, patients will undergo surgery. After recovery, patients will be given the following adjuvant treatment:
- Arm A: Herceptin + Perjeta Arm B: Kadcyla + Perjeta Treatment can be stopped due to disease recurrence, unacceptable toxicity, withdrawal of consent, or study termination. Study is expected to last approximately 45 months.
This trial is sponsored by F. Hoffmann-La Roche. 
- Condition: Breast Cancer
- Phase: III
- Enrollment: 444
- Start: June 2014
- Estimated Completion: January 2018
- Last verified: July 2015
Last Editorial review: July 30, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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