IRB #

STUDY00019830

Title

A Randomized Phase II Study to Evaluate Efficacy of T-DM1 with or without Palbociclib in the Treatment of Patients with Metastatic HER2 Positive Breast Cancer

Principal Investigator

Zahi Mitri

Study Purpose

The purpose of this study is to see if combination treatment of T-DM1 with palbociclib is better than T-DM1 alone for metastatic HER2-positive breast cancer.

Medical Condition(s)

Metastatic HER2-positive Breast Cancer

Eligibility Criteria

Male of female 18 years or older
Recurrent or metastatic HER2-positive breast cancer
Previously treated with pertuzumab (neoadjuvant or metastatic setting)
No more than 2 lines of therapy in the metastatic disease setting

Age Range

18 - 101

Healthy Volunteers Needed

No

Duration of Participation

You will receive the study drug for as long as your cancer does not get worse or you do not have bad side effects. After you finish study drug the investigator and/or study team will continue to watch you for side effects and follow your condition either with clinic visits or phone calls. This follow-up period will last until study completion.

Minors Included

No

Contact

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

Sponsor

The University of Arizona Cancer Center

Recruitment End

08/01/2022

Compensation Provided

No


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