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

NCT06078384 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 354

Last updated 2025-11-17

No results posted yet for this study

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.

Conditions

  • Triple-negative Breast Cancer

Interventions

DRUG

Pembrolizumab 25 mg/ml

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.

DRUG

Paclitaxel injection

Injectable solution for IV administration. Dose of 80 mg/m² weekly.

Sponsors & Collaborators

  • MSD France

    collaborator INDUSTRY

  • SOLTI Breast Cancer Research Group

    collaborator OTHER

  • Gustave Roussy, Cancer Campus, Grand Paris

    collaborator OTHER

  • Vall Hebron Insitut Recerca

    collaborator NETWORK

  • UNICANCER

    lead OTHER

Principal Investigators

  • Elie Rassy, MD · Gustave Roussy, Villejuif, France

  • Barbara Pistilli, MD · Gustave Roussy, Villejuif, France

  • Mafalda Oliveira, MD · HOSPITAL VALL D'HEBRÓN, Barcelona, Spain

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-27
Primary Completion
2032-01-01
Completion
2032-01-01

Countries

  • France
  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06078384 on ClinicalTrials.gov