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A Randomized, Double-Blind, Phase III Trial in First-Line HER2-Positive Metastatic Breast Cancer

University of North Carolina at Chapel Hill


To study how well certain chemotherapy drugs will work in conjunction with Immunotherapy drugs in treating patients with breast cancer that has spread to other parts of the body.


Cancer, Elderly, Men's Health, Older Adults, Women's Health


Drug or Biologic



18 - 99 years


Study Population

Female and Male Patients with breast cancer that has spread to other areas of the body.


Jayadev Manikkam umakanthan

UNC Hospitals - UNCPN

For questions, contact:

Kerry Finch, RN, CCRP
(252) 962-4150
Visit Website

Recruitment Period End

December 31, 2020


Primary Location
UNC Cancer Care at Nash
Danny Talbott Cancer Center, 2460 Curtis Ellis Dr, Rocky Mount, NC 27804, USA

Study Qualifications

Gender Any

Age Range 18 - 99 years

Participant qualification(s) Confirmation of metastatic disease Must have measurable disease based on RECIST 1.1 Tumor specimen, at time of diagnosis, must be determined to be HER2-positive and have testing for ER and PgR testing. Must have imaging of the chest/abdomen/pelvis.

Not eligible if: Known leptomeningeal carcinomatosis Metastatic disease limited to the CNS History of systemic anti-cancer therapy Uncontrolled hypertension History or active cardiac disease that would prevent the use of the drugs included in the treatment. Known history or risk of autoimmune disease. Active hepatitis B virus or hepatitis C virus

Number of Visits

    » 50 + In person visit(s)

    You will be seen in person for screening, consent, all of infusion treaments and lab work. Scheduled imaging as required by study.

    » 0 Remote visit(s)

Participation Period

9 years


By clicking I am interested, your contact information will be sent to the researcher/study coordinator for this study. The coordinator will respond by email with additional information on how to proceed.