Sacituzumab Govitecan-hziy and Pembrolizumab for Triple Negative Breast Cancer

Study of Sacituzumab Govitecan-hziy 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 (ASCENT-05/AFT-65 OptimICE-RD/GBG 119/NSABP B-63)

Recruiting Phase 3 Interventional Study
Triple Negative Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo. Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
1,514 (estimated)
Sponsor
Gilead Sciences · Industry
Who this trial is looking for

This trial is looking for adults with triple negative breast cancer that remains after surgery and treatment. Participants will receive an experimental treatment combining two medications after recovery from surgery.

Are You a Good Fit for This Trial?

You may be able to join if

  • I am over 18 years old
  • I have triple negative breast cancer after surgery
  • I have recovered from my surgery
  • I have had the right kind of radiotherapy
  • I have adequate organ function
  • I can provide tissue samples from my treatment
  • I have an ECOG performance status of 0-1

You may not be able to join if

  • I have stage IV breast cancer
  • I have a history of another invasive breast cancer
  • I have had treatment with specific T-cell receptor agents
  • I have evidence of disease recurring after treatment
  • I have received certain types of prior cancer treatment
  • I have a BRCA gene mutation
  • I had a heart attack or serious heart issue in the last 6 months
  • I have a serious infection needing treatment

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial
The goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (SG) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (TPC) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgica…
Trial Locations
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Eligibility Criteria
Key Inclusion Criteria: * Age \> 18 years, with residual invasive triple negative breast cancer (TNBC) in the breast or lymph nodes after neoadjuvant therapy and surgery: * TNBC criteria for the study is defined as estrogen receptor (ER) and progesterone receptor (PR) ≤ 10%, human epidermal grow…
Contacts

Gilead Clinical Study Information Center

1-833-445-3230 (GILEAD-0)

GileadClinicalTrials@gilead.com

CONTACT