IRB #

STUDY00019200

Title

A PHASE 3, MULTICENTER, RANDOMIZED,
OPEN-LABEL, ACTIVE-CONTROLLED TRIAL OF
DS-8201A, AN ANTI-HER2-ANTIBODY DRUG
CONJUGATE (ADC), VERSUS TREATMENT OF
PHYSICIAN’S CHOICE FOR HER2LOW,
UNRESECTABLE AND/OR METASTATIC BREAST
CANCER SUBJECTS

Principal Investigator

Zahi Mitri

Study Purpose

The purpose of this study is to determine if the experimental drug, DS-8201a, would be effective in the treatment of HER2-low expressing breast cancer and compare it to other standard treatments.

Medical Condition(s)

HER2-Low Unresectable and/or Metastatic Breast Cancer

Eligibility Criteria

Men or Women 18 years and older
HER2-Low Expressing Breast Cancer that is Unresectable or Metastatic
Has been treated with at least 1 and at most 2 prior lines of chemotherapy in the metastatic setting
If hormone receptor positive, has been treated with a CDK 4/6 inhibitor in the metastatic setting

Age Range

18 - 100

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 40 days after you have stopped treatment and every three months after that. This follow-up period can last for many years.

Minors Included

No

Contact

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

Sponsor

Recruitment End

11/05/2030

Compensation Provided

No


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