TIL-Driven De-escalated Chemotherapy in Stage I-II TNBC

This is a phase II clinical study testing a more personalized and lighter chemotherapy approach for women with stage I or II triple-negative breast cancer. The treatment is adjusted based on signs from the immune system (called tumor-infiltrating lymphocytes, or TILs) and imaging results during treatment. Patients with stage I triple-negative breast cancer (regardless of TIL levels) and those with stage II disease and high TILs (50% or more) will receive a combination of two chemotherapy drugs (carboplatin and a taxane) for four cycles. If imaging shows the tumor has completely disappeared a

Trial Details

NCT ID
NCT07074106
Phase
PHASE2
Sponsor
D'Or Institute for Research and Education
Status
RECRUITING
Cancer Type
Triple Negative (TNBC) Breast Cancer
Interventions
  • Carboplatin and a Taxane
Locations (sample)
  • Brasília, Brazil|-15.77972,-47.92972
  • Curitiba, Brazil|-25.42778,-49.27306
  • Rio de Janeiro, Brazil|-22.90642,-43.18223
  • Salvador, Brazil|-12.97563,-38.49096
  • São Paulo, Brazil|-23.5475,-46.63611

Key Eligibility Criteria

  • Histologically confirmed primary invasive breast carcinoma.
  • One of the following conditions:
  • Clinical stage T1c N0 M0 with any level of TILs; or
  • Clinical stage T2 N0 M0 with TILs ≥ 50%.

For full eligibility, visit ClinicalTrials.gov.

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