Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC
Adjuvant Pembrolizumab and Chemotherapy or Surveillance in Early Triple Negative breAst Cancer With High Stromal Tumor-infiltrating Lymphocytes (TILs) Score
UNICANCER
354 participants
Dec 27, 2024
INTERVENTIONAL
Conditions
Summary
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 significant tumor lymphocyte infiltration. The ETNA study is a phase II trial designed to evaluate a chemotherapy de-escalation strategy in patients with TNBC T1b/c N0M0 and stromal TILs (sTILs) ≥ 30%. ETNA comprises two cohorts defined according to the level of TILs and the age of patients. Patients aged \> 40 years with 30% ≤ sTILs \< 50% and those aged ≤ 40 years with 30% ≤ sTILs \< 75% will be included in the cohort 1 and will receive adjuvant pembrolizumab 200 mg every three weeks for 9 cycles and Paclitaxel 80 mg/m² weekly for 12 cycles. Patients aged \> 40 years with sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75% will be included in cohort 2 and will not receive adjuvant treatment, they will undergo standard surveillance every six months.
Eligibility
Plain Language Summary
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Interventions
Pembrolizumab drug product is a sterile-filtered liquid and is aseptically filled into single-use vials. The vials contain 4 mL of sterile solution for IV infusion.
Injectable solution for IV administration. Dose of 80 mg/m² weekly.
Locations(44)
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NCT06078384