A Study of Kadcyla (Trastuzumab Emtansine) Plus Perjeta (Pertuzumab) Following Anthracyclines in Comparison With Herceptin (Trastuzumab) Plus Perjeta and a Taxane Following Anthracyclines as Adjuvant Therapy in Patients With Operable HER2-Positive Primary Breast Cancer (NCT01966471)
This two-arm, randomized, open-label, multicenter study will evaluate the efficacy and safety of ado-trastuzumab emtansine (T-DM1, Kadcyla®; Genentech, Inc.) in combination with pertuzumab (Perjeta®; Genentech, Inc.) versus trastuzumab (Herceptin®;Genentech, Inc.) in combination with Perjeta and a taxane as adjuvant therapy in patients with HER2-positive primary invasive breast cancer. Following surgery and anthracycline-based chemotherapy, patients will receive either Kadcyla 3.6 mg/kg and Perjeta 420 mg intravenously (iv) every three weeks or trastuzumab (Herceptin®;Genentech, Inc.) 6 mg/kg iv every three weeks in combination with Perjeta and a taxane. Anticipated time on HER2 targeted study treatment is up to 1 year.
This trial is sponsored by F. Hoffmann-La Roche. 
- Condition: Breast Cancer
- Phase: III
- Estimated Enrollment: 2500
- Start: January 2014
- Estimated Completion: September 2023
- Last verified: July 2015
Last Editorial review: July 30, 2015
Information based on ClinicalTrials.gov (NIH/NCI) and other sources.
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