Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Podpisanie świadomej zgody na uczestnictwo w badaniu przed rozpoczęciem procedur badawczych
- •Wiek 18 lat lub więcej
- •Dobry stan ogólny (w skali ECOG: 0 lub 1)
- •Potwierdzony histologicznie rak piersi o charakterze potrójelnie negatywnym (brak HER2, receptorów estrogenowych i progesteronowych), całkowicie usunięty chirurgicznie, na wczesnym etapie (pT1b/c N0M0)
- •Odpowiednio wycięty nowotwór: zabiegi oszczędzające pierś lub mastektomia z zachowaniem piersi/brodawki lub skóry, ze światłem bez guza
- •Biopsja węzła wartownika lub usunięcie węzłów chłonnych pachwinowych (co najmniej 6 węzłów)
- •Rozpoczęcie leczenia w terminie 4-12 tygodni (lub do 12 tygodni dla drugiej grupy) po operacji piersi
- •Wynik analizy komórek odpornościowych w guzie na poziomie 30-50% (lub wyżej w zależności od wieku i grupy)
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Last updated (source)
- July 24, 2026
- Sex
- No restrictions
Therapies / drugs in trial
Locations (44)
CHU Amiens Picardie_Site Sud
Amiens, France
Institut Sainte Catherine
Avignon, France
Centre Hospitalier de la Côte Basque
Bayonne, France
Institut Bergonié
Bordeaux, France
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, France
Centre François Baclesse
Caen, France
Pôle Santé Republique
Clermont-Ferrand, France
Centre Jean Perrin
Clermont-Ferrand, France
Centre Georges-François Leclerc
Dijon, France
Hôpital Franco-Britannique-Fondation Cognacq-Jay
Levallois-Perret, France
CHU de Limoges
Limoges, France
Centre Léon Bérard
Lyon, France
Hopital Privé Jean Mermoz
Lyon, France
Institut Paoli-Calmettes
Marseille, France
Institut régional du Cancer de Montpellier
Montpellier, France
Hôpital privé du confluent
Nantes, France
Centre Antoine Lacassagne
Nice, France
CHU de Nîmes
Nîmes, France
Centre Hospitalier de Pau
Pau, France
Hôpital Privé des côtes d'Armor
Plérin, France
Hôpital NOVO
Pontoise, France
Centre Hospitalier de Cornouaille
Quimper, France
Clinique La Croix du Sud
Quint-Fonsegrives, France
Institut Godinot
Reims, France
Centre Eugène Marquis
Rennes, France
CHU de Saint Etienne
Saint-Etienne, France
Institut Claudius Regaud
Toulouse, France
CHU Bretonneau
Tours, France
Centre Alexis Vautrin
Vandœuvre-lès-Nancy, France
Gustave Roussy
Villejuif, France
Hospital General Universitario Dr.Balmis
Alicante, Spain
Ico Badalona
Badalona, Spain
Hospital Vall D'Hebrón
Barcelona, Spain
Hospital Clinico Universitario Virgen de La Arrixaca
El Palmar, Spain
Hospital Universitario Clinico San Cecilio
Granada, Spain
Ico Hospitalet
L'Hospitalet de Llobregat, Spain
Complejo Asistencial Universitario de Leon
León, Spain
Hu Arnau de Vilanova Lleida
Lleida, Spain
Hospital Ramon Y Cajal
Madrid, Spain
Hospital 12 de Octubre
Madrid, Spain
Hospital Universitari Son Espases
Palma de Mallorca, Spain
Hospital Sant Joan de Reus
Reus, Spain
Hospital Universitario Virgen Del Rocio
Seville, Spain
Hospital Clínico Valencia
Valencia, Spain
Trial contact
Telma ROQUE, PhD
Sylvie Mijonnet
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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