A Study Assessing the Effect of Decreasing Chemotherapy in Patients with Breast Cancer without Evidence of Cancer Remaining after Presurgical Chemotherapy and HER2-Targeted Therapy

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Full Title

(CompassHER2-pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete Response (EA1181) (CIRB)

Purpose

In this study, researchers want to assess the effect of reducing chemotherapy for patients with stage II-IIIa HER2-positive breast cancer. Patients will be treated with a single chemotherapy drug called paclitaxel in combination with HER2-targeted therapy (trastuzumab and pertuzumab) before surgery. These medications are given intravenously (by vein).

If there is no evidence of cancer after breast cancer surgery, patients will continue to receive only trastuzumab and pertuzumab to complete one year of treatment, as well as the radiation therapy and hormonal therapy they normally would receive after surgery. Patients who do have cancer remaining after surgery may receive additional chemotherapy. It is hoped that giving paclitaxel, trastuzumab, and pertuzumab before surgery may enable fewer chemotherapy drugs to be given without compromising patient outcomes.

Eligibility

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

  • Patients must have stage II-IIIa breast cancer that has not yet been treated and is positive for the HER2 protein.
  • 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. Shanu Modi at 646-888-5243.

Protocol

20-511

Phase

II

Investigator

Co-Investigators