COMPASS HER2+ Breast with Residual Disease (A011801)

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.

Who Can Participate?

Eligibility

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.

What is Involved?

Description

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

Vijay
Paryani

Protocol Number

PRO00112730

NCT ID

NCT04457596

Phase

III

Enrollment Status

Open to Enrollment
ClinicalTrials.gov