A Phase II Study of Tucatinib and Trastuzumab Deruxtecan in People with HER2-Positive Advanced Breast Cancer

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Full Title

A Single Arm, Open Label Phase 2 Study of Tucatinib in Combination with Trastuzumab Deruxtecan in Subjects with Previously Treated Unresectable Locally-Advanced or Metastatic HER2+ Breast Cancer

Purpose

The purpose of this study is to assess the safety and effectiveness of combining the drugs tucatinib and trastuzumab deruxtecan (also called T-DXd) in people with inoperable or metastatic HER2-positive breast cancer. Both drugs on their own are standard treatments for this type of breast cancer. In addition, both drugs target cancer cells that make HER2, and this targeting action may slow or stop the growth of cancer.

Researchers think that tucatinib and T-DXd may be more effective when given in combination than on their own. Tucatinib is taken orally (by mouth) and T-DXd is given intravenously (by vein).

Eligibility

To be eligible for this study, patients must meet several requirements, including:

  • Participants must have inoperable or metastatic HER2-positive breast cancer that continues to grow despite at least two previous regimens of anti-HER2 therapies.
  • At least 3 weeks must pass since the completion of previous treatments and receipt of the study medications.
  • Patients must be physically well enough that they are able to be mobile, take care of themselves, and engage in all but physically strenuous activities. For example, they must be well enough that they could carry out office work or light housework
  • This study is for people age 18 and older.

For more information about this study and to ask about eligibility, please contact the office of Dr. Shanu Modi at 646-888-4564.

Protocol

21-397

Phase

II

Disease Status

Relapsed or Refractory

Investigator

Co-Investigators

Diseases