IRB #

STUDY00020112

Title

Randomized, Double-blind, Phase 3 Study of Tucatinib or Placebo in Combination with Ado-trastuzumab Emtansine (T-DM1) for Subjects with Unresectable Locally-advanced or Metastatic HER2+ Breast Cancer (HER2CLIMB-02)

Principal Investigator

Zahi Mitri

Study Purpose

We are studying tucatinib plus T-DM1 to find out what the side effects are and if it works for treating HER2-positive breast cancer. We want to find out how effective tucatinib plus T-DM1 is compared to treatment with only T-DM1.

Medical Condition(s)

Unresectable Locally-advanced or Metastatic HER2-positive breast cancer

Eligibility Criteria

Male of female 18 years and older
unresectable locally-advanced or metastatic HER2-positive breast cancer
prior treatment with a taxane and trastuzumab in any setting, separately or in combination

Age Range

18 - 101

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study drugs for as long as your cancer does not get worse or you do not have bad side effects. After you are done getting treated with the study drugs, we will contact you every 9 weeks until the study closes to see how you are doing and to ask about your cancer.

Minors Included

No

Contact

Knight Cancer Institute Clinical Trials
trials@ohsu.edu
503 494-1080

Sponsor

Seattle Genetics

Recruitment End

12/30/2031

Compensation Provided

No


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