A Phase III Study of Alpelisib in Combination with Trastuzumab and Pertuzumab in People with Breast Cancer

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Full Title

EPIK-B2: A Two Part, Phase III, Multicenter, Randomized (1:1), Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Alpelisib (BYL719) in Combination with Trastuzumab and Pertuzumab as Maintenance Therapy in Patients with HER2-positive Advanced Breast Cancer with a PIK3CA Mutation

Purpose

The purpose of this study is to test the safety of alpelisib in combination with trastuzumab and pertuzumab in people with HER2-positive advanced breast cancer. Researchers want to find the specific dose of alpelisib that can be given safely in combination with trastuzumab and pertuzumab. When this dose has been found, they will then assess it in another group of patients with HER2-positive advanced breast cancer to see if combining alpelisib with trastuzumab and pertuzumab is more effective than just the combination of trastuzumab and pertuzumab. 

Trastuzumab and pertuzumab are antibodies that target and kill cancer cells which express the HER2 protein. Alpelisib works by blocking PI3K, an enzyme which, when mutated, promotes the growth of several types of cancer, including many breast cancers. Alpelisib has not been approved by the U.S. FDA as a treatment for HER2-positive advanced breast cancer, but it has been approved to treat other types of breast cancer. Alpelisib is taken orally (by mouth) and trastuzumab and pertuzumab are given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have inoperable or metastatic HER2-positive breast cancer that has been previously treated with induction therapy with up to 6 cycles of a taxane (such as docetaxel, paclitaxel, or nab-paclitaxel) plus trastuzumab and pertuzumab.
  • Patients must be physically well enough that they are fully ambulatory, capable of all self-care, and capable of all but physically strenuous activities. As an example, patients must be well enough that they would be able to carry out office work or light housework.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Sarat Chandarlapaty at 646-888-4311

Protocol

20-406

Phase

III

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators