IRB #

STUDY00015366

Title

ONT-380-206: Phase 2 Randomized, Double-Blinded, Controlled Study of tucatinib vs. Placebo in Combination with Capecitabine and Trastuzumab in
Patients with Pretreated Unresectable Locally Advanced or Metastatic HER2+ Breast Carcinoma

Principal Investigator

Kathleen Kemmer

Study Purpose

To compare the safety and effectiveness of Tucatinib (the study drug) vs placebo in combination with capecitabine and trastuzumab in adults with unresectable locally advanced or metastatic HER2+ Breast Cancer

Medical Condition(s)

unresectable locally advanced HER2+ Breast Cancer
metastatic HER2+ Breast Cancer

Eligibility Criteria

1. Male or female age 18 or older.
2. HER2+ confirmed breast cancer
3. Have progressed on at least one prior treatment for locally advanced unresectable or metastatic breast cancer.
4. Previously received a taxane, trastuzumab, pertuzumab, or T-DM1


Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Treatment will continue until your disease progresses, you can’t tolerate the treatment, or you and/or your doctor decide to stop treatment. After that participants will be contacted by phone every 3 months until the end of the study.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080
knight@ohsu.edu

Sponsor

Cascadian Therapeutics, Inc.

Recruitment End

12/31/2030

Compensation Provided

No


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