Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC

Triple-negative breast cancer (TNBC) is a group of tumors that occurs mainly in young, premenopausal women and accounts for 10-20% of breast cancers. Over the past decade, the incidence of women diagnosed with early-stage TNBC has significantly increased due to the widespread use of screening mammography. Treatment of patients with localized TNBC mainly involves surgery and (neo)adjuvant chemotherapy with or without radiotherapy. However, the benefit of chemotherapy may be controversial in patients with early-stage TNBC defined by small size and absence of lymph node involvement, and with sign

Trial Details

NCT ID
NCT06078384
Phase
PHASE2
Sponsor
UNICANCER
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Pembrolizumab 25 mg/ml
  • Paclitaxel injection
Locations (sample)
  • Amiens, France|49.9,2.3
  • Avignon, France|43.94834,4.80892
  • Bayonne, France|43.49316,-1.473
  • Bordeaux, France|44.84124,-0.58046
  • Bordeaux, France|44.84124,-0.58046

Key Eligibility Criteria

  • Understand, sign, and date the written informed consent form prior to any protocol- specific procedures performed,
  • Men and women aged ≥ 18 years,
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1,
  • Histologically confirmed and radically removed pT1b/c N0M0 TNBC as defined according to AJCC TNM stage-8th version,

For full eligibility, visit ClinicalTrials.gov.

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