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)

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-surgical treatment.

Trial Details

NCT ID
NCT05633654
Phase
PHASE3
Sponsor
Gilead Sciences
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Sacituzumab govitecan-hziy (SG)
  • Pembrolizumab
  • Capecitabine
Locations (sample)
  • Birmingham, Alabama, United States|33.52066,-86.80249
  • Huntsville, Alabama, United States|34.7304,-86.58594
  • Glendale, Arizona, United States|33.53865,-112.18599
  • Phoenix, Arizona, United States|33.44838,-112.07404
  • Prescott Valley, Arizona, United States|34.61002,-112.31572

Key Eligibility 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 growth factor receptor 2 (HE…
  • Adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from sur…
  • Submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue.

For full eligibility, visit ClinicalTrials.gov.

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