Alliance A011801

Official Title

T-DM1 and Tucatinib Compared With T-DM1 Alone In Preventing Relapses In People With High Risk Her2-Positive Breast Cancer

Study Purpose

To compare the usual treatment with T-DM1 alone to T-DM1 plus tucatinib.

Diagnosis

Patient has human epidermal growth factor receptor 2 (HER2)-positive breast cancer, and you have already received treatment with chemotherapy and anti-HER2 targeted therapies followed by surgery. At the time of the surgery, cancer was still present in the breast and/or lymph nodes and was removed.

Eligibility

Clinical stage T1-4, N0-3 at diagnose with residual invasive disease post-op.

If HR - negative, residual in breast and/or node, if HR+ positive, residual must be in node.

Micro mets is eligible.

At least 6 cycles chemo pre-op.

Patients must sign an approved informed consent and authorization permitting release of personal health information.

Intervention

There are two study groups:

• Usual Approach Group: Patients in this group will get the usual drug used to treat this type of cancer, T-DM1 and a placebo.

• Study Group: Patients will get a study drug called tucatinib plus the usual drug used to treat this type of cancer, T-DM1.