NeoAdj. Therapy Comparing Sacituzumab Govitecan (SG) vs. SG+Pembrolizumab in Low-risk, Triple-neg. EBC (ADAPT-TN-III)

TNBC is known for poor prognosis, aggressive patterns of disease, and significant molecular heterogeneity. (Neo)adjuvant chemotherapy (NACT) is standard of care in all node-positive and in node-negative patients with a tumour size \>5 mm according to current National Comprehensive Cancer Network (NCCN) guidelines. However, TNBC patients with lower stage disease do clearly have a better prognosis compared to more advanced stages. Patients with stage I-II node-negative disease have 3-5 year iDFS rates of 80-90% (with majority of relapses within the first three years) as shown in several trials.A

Trial Details

NCT ID
NCT06081244
Phase
PHASE3
Sponsor
West German Study Group
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Sacituzumab govitecan
  • Pembrolizumab
Locations (sample)
  • Baden-Baden, Baden-Wurttemberg, Germany|48.7606,8.23975
  • Böblingen, Baden-Wurttemberg, Germany|48.68212,9.01171
  • Freiburg im Breisgau, Baden-Wurttemberg, Germany|47.9959,7.85222
  • Heilbronn, Baden-Wurttemberg, Germany|49.13995,9.22054
  • Tübingen, Baden-Wurttemberg, Germany|48.52266,9.05222

Key Eligibility Criteria

  • ER + PR negative or low positive (≤10% positive cells in IHC), and HER2 negative (i.e., IHC 0 - 1+ or IHC 2+ with FISH negative) breast cancer
  • All patients, independent from gender
  • ≥18 years at diagnosis
  • Histologically confirmed unilateral, primary invasive carcinoma of the breast Note: bilateral, multicentric, or multifocal carcinoma may be include…

For full eligibility, visit ClinicalTrials.gov.

Check If You May Be Eligible

Trialify translates complex eligibility criteria into plain yes-or-no questions to help you understand if this trial might be right for you.

Find Triple Negative (TNBC) Breast Cancer Trials on Trialify →