At a glance
ClinicalIndex Comparison Record- ✓Men and women aged ≥18 years
- ✓ECOG performance status 0 or 1
- ✓Histologically confirmed pT1b/c N0M0 TNBC (negative HER2, ER, PgR)
- ✓HER2 negativity by ISH/IHC per ASCO/CAP criteria; ER/PgR negativity <10% by IHC
- ✕History of invasive malignancy ≤3 years prior except adequately treated basal/squamous cell skin cancer
- ✕Prior chemotherapy or targeted therapy within past 12 months
- ✕Prior DCIS/LCIS treated with systemic, hormonal therapy, or radiotherapy to ipsilateral breast
- ✕Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, or other co-inhibitory T-cell receptor agents (CTLA-4, OX-40, CD137)
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Adjuvant Pembrolizumab and Chemotherapy or Surveillance in Early Triple Negative breAst Cancer With High Stromal Tumor-infiltrating Lymphocytes (TILs) Score
In Brief
A Phase 2 clinical trial evaluating Pembrolizumab 25 mg/ml and Paclitaxel injection for Triple-negative Breast Cancer. Currently recruiting, targeting 354 participants across 44 sites in 2 countries.
Detailed 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.
Study Details
Timeline
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.