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FDA Approves Adjuvant Pertuzumab Regimen for HER2+ Breast Cancer

Silas Inman @silasinman
Published: Wednesday, Dec 20, 2017

Dr. Sandra Horning

Sandra Horning, MD
The FDA has approved pertuzumab (Perjeta) in combination with trastuzumab (Herceptin) and chemotherapy as an adjuvant treatment for patients with HER2-positive early breast cancer at high risk for recurrence, based on findings from the APHINITY trial.

The phase III double-blind, placebo-controlled APHINITY trial randomized patients with operable HER2+ early (T1-3) breast cancer in a 1:1 ratio to adjuvant treatment with trastuzumab plus chemotherapy (anthracycline or non-anthracycline-containing regimen) with pertuzumab (n = 2400) or placebo (n = 2404). Patients had undergone mastectomy or lumpectomy. Overall, 63% of the participants had node-positive disease and 36% had HR-negative disease.

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