COMPASS HER2+ Breast with Residual Disease (A011801)

What is the Purpose of this Study?

We are doing this study to find out if adding a drug called tucatinib to the usual treatment of T-DM1 on its own can help prevent breast cancer from returning.

What is the Condition Being Studied?

Breast Cancer

Who Can Participate in the Study?

Adults 18+ who:

  • Are diagnosed with HER2+ breast cancer
  • Have been previously treated with one of the following chemotherapy regimens: THP, TMP, AC-TH(P); TCH(P); FAC-TH(P), or FEC-TH(P)

For more information about who can join this study, please contact the study team at nick.jeffries@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will be randomly assigned (like a coin flip) to 1 of 2 groups:

  • One group will get T-DMI and placebo ("sugar pills" that contain no medicine)
  • The other group will get T-DMI and tucatinib (the study regimen)

T-DMI is given as an infusion through a vein (IV) in the arm once every 3 weeks. Tucatinib and the placebo are pills that you will take by mouth twice each day while you are in the study.

Participation in this study, whether you are assigned to get the study regimen or the usual treatment, will last for up to 42 weeks.

Study Details

Full Title
Alliance A011801:The CompassHER2 trials (COMprehensive use of Pathologic Response ASSessment to optimize therapy in HER2-positive breast cancer): CompassHER2 Residual Disease (RD), a double-blinded, phase III randomized trial of T-DM1 and placebo compared with T-DM1 and tucatinib(NCT #04457596)
Principal Investigator
Headshot of Vijay Paryani
Clinical Associate in the Department of Medicine
Protocol Number
IRB: PRO00112730
NCT: NCT04457596
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL