Adults with HER2 (Human Epidermal Growth Factor Receptor 2)-positive early breast cancer with residual invasive disease following preoperative chemotherapy and surgery invited to be in a research study

UVA Tracking #
HSR200391
Principal Investigator
Patrick M Dillon
Contact
Olena Glushakova
Contact Email
Contact Phone
434.409.6206
Official Trial Title
A PHASE 3, MULTICENTER, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED STUDY OF TRASTUZUMAB DERUXTECAN (T-DXd) VERSUS TRASTUZUMAB EMTANSINE (T-DM1) IN SUBJECTS WITH HIGH-RISK HER2-POSITIVE PRIMARY BREAST CANCER WHO HAVE RESIDUAL INVASIVE DISEASE IN BREAST OR A
Study Description

The University of Virginia is conducting a clinical research study for adults ages 18 and over, who have HER2 (Human Epidermal Growth Factor Receptor 2)-positive breast cancer. The purpose of this study is to determine if T-DXd would be effective in the treatment of HER2-positive early breast cancer in subjects that have already had treatment prior to breast cancer surgery, specifically for subjects that are considered at high risk for their breast cancer to return. Once it has been confirmed that the study is suitable for you, you will be assigned to receive either T-DXd or the comparator drug (T-DM1). The assignment will be in a 1:1 ratio, with one subject going to the T-DXd group for every one subject going to comparator study treatment group.

After the screening period, if enrolled on this study treatment is given once every 3 weeks for a total of 42 weeks (14 treatments). After treatment there is a follow-up period that could last up to 10 years.

Study-related procedures that are being done beyond your standard of care will be provided at no cost to you or your insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT04622319

Compensation

NA