ASCENT-05 for Triple Negative Breast Cancer with Residual Disease after Surgery

What is the Purpose of this Study?

We are doing this study to find out if a study drug called sacituzumab govitecan can improve outcomes for patients with high risk, early triple negative breast cancer (TNBC). We want to know if giving this drug in combination with pembrolizumab will work better than pembrolizumab on its own or better than pembrolizumab + capecitabine.

What is the Condition Being Studied?

High-Risk, Early Triple-Negative Breast Cancer (TNBC) Without Mutations in the BRCA1 or BRCA2 Genes

Who Can Participate in the Study?

Adults ages 18+ who:

  • Are diagnosed with high-risk, early TNBC
  • Have already received surgery and neoadjuvant therapy (chemotherapy, radiation therapy, immunotherapy, hormone therapy, or targeted therapy)
  • Do not have mutations in the BRCA1 or BRCA2 genes

For more information about who can join this study, please contact the study team at sam.womack@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join this study, you will get a random assignment (like a coin flip) to 1 of 2 groups:

  • Group A: if you are in this group, you will get the study drug in combination with pembrolizumab
  • Group B: if you are in this group, the study doctor will choose 1 of 2 options that they feel is most appropriate for you

If you are in Group A, you will get your study regimen over the course of 8 time periods called cycles. Each cycle lasts for 21 days. You will get a 10 mg/kg dose of the study drug on the 1st and 8th day of each cycle, and you will get a 200 mg dose of pembrolizumab on the 1st day of each cycle.

If you are in Group B, you will get your study regimen over the course of 8 time periods called cycles. Each cycle lasts for 21 days. The study doctor will decide whether you will get pembrolizumab alone or in combination with capecitabine. If you get pembrolizumab alone, you will get a 200 mg dose on the first day of each cycle. If you get pembrolizumab + capecitabine, you will get a 200 mg dose of pembrolizumab on the first day of each cycle and you will also take capecitabine by mouth twice a day for the first 14 days of each cycle.

Study Details

Full Title
A Randomized, Open-label, Phase 3 Study of Adjuvant Sacituzumab Govitecan and Pembrolizumab Versus Treatment of Physician?s Choice in Patients with Triple Negative Breast Cancer Who Have Residual Invasive Disease After Surgery and Neoadjuvant Therapy
Principal Investigator
Professor of Medicine
Protocol Number
IRB: PRO00114654
NCT: NCT05633654
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
OPEN TO ACCRUAL
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