AzTrials
AzTrials

Triple-negative Breast CancerPhase 2ETNANCT06078384

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

A Phase 2 study testing Pembrolizumab 25 mg/ml and Paclitaxel injection in people with Triple-negative Breast Cancer, run by UNICANCER at 44 sites in 2 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Triple-negative Breast Cancer
What is being tested?
Pembrolizumab 25 mg/ml and Paclitaxel injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
354 participants
Where
44 sitesin 2 countries
Study dates
27 Dec 2024to 1 Jan 2032
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Understand, sign, and date the written informed consent form prior to any protocol- specific procedures performed,
  • Men and women aged ≥ 18 years,
  • Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1,
  • Histologically confirmed and radically removed pT1b/c N0M0 TNBC as defined according to AJCC TNM stage-8th version,
  • Histologically documented TNBC (negative HER2, ER, and PgR status). HER2 negativity is defined by local laboratory assessment using in situ hybridization and immunohistochemistry assays as per ASCO/CAP criteria and ER/PgR negativity is defined by local laboratory assessment < 10% using immunohistochemistry assays,
  • Bilateral and/or multifocal primary tumor is allowed and the tumor with the most advanced T stage should be used to asses for eligibility. If multifocal tumor, a pathologic confirmation of TNBC is required for each focus,
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  • Adequately excised breast cancer: subjects must have undergone either breast- conserving surgery or mastectomy/nipple- or skin-sparing mastectomy.
  • For subjects who undergo breast-conserving surgery, the margins of the resected specimen must be histologically free of invasive tumor and ductal carcinoma in situ (DCIS) as determined by the local pathologist. Reresections to ensure no ink on tumor margins are allowed. Subjects with margins positive for lobular carcinoma in situ (LCIS) are eligible without additional resection.
  • For subjects who undergo mastectomy/nipple- or skin-sparing mastectomy, margins must be free of gross residual tumor. It is recommended that subjects should have a negative microscopic margin in accordance with local pathology protocol,
  • Have had sentinel lymph node biopsy (SLNB) and/or axillary lymph node dissection (ALND) for evaluation of pathologic nodal status.
  • Axillary nodal dissection(s) should yield a total of at least six nodes (including the axillary lymph nodes resected at the SLNB plus the lymph nodes collected at the axillary nodal dissection),
  • At least 4 weeks but no more than 12 weeks between definitive breast surgery (or the last surgery with curative intent if additional resection is required for breast cancer) and treatment initiation for cohort 1 and no more than 12 weeks for cohort 2,
  • Centrally assessed TILs score from surgical formalin-fixed paraffin embedded (FFPE) tumor sample, using an H\&E stained diagnostic digital slide, according to the most recent International TILs Working Group guidelines,
  • Cohort 1 will include patients aged > 40 years with 30% ≤ sTILs < 50% and those aged
  • 40 years with 30% ≤ sTILs < 75%
  • Cohort 2 will include patients aged > 40 years with sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75%
  • Women of childbearing potential have a negative serum pregnancy test within 72 hours prior to receiving the first dose of study medication for cohort 1 and within 7 days of inclusion for cohort 2,
  • Women of childbearing potential must agree to use protocol-specified method(s) of contraception for 3 years after patient inclusion. Men subjects who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception during trial treatments and for at least 6 months after the last dose of trial treatments.
  • Females of childbearing potential are those who have not been surgically sterilized or have not been free from menses for > 1 year,
  • Patients affiliated to the social security system (or equivalent)- France only,
  • Patient is willing and able to comply with the protocol for the duration of the trial including undergoing treatment and scheduled visits, and examinations including follow-up.
  • Additional inclusion criteria for subjects of cohort 1:
  • Left ventricular ejection fraction (LVEF) of ≥ 50% as assessed by echocardiogram or cardiac scintigraphy,
  • Demonstrate adequate organ function within 7 days of inclusion
  • Absolute Neutrophil Count (ANC) ≥ 1,500 /µL
  • Platelets ≥ 100,000 /µL
  • Hemoglobin ≥ 9 g/dL
  • Creatinine clearance ≥ 30 mL/min for subject with creatinine levels > 1.5 x institutional upper limit of normal (ULN)
  • Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
  • Albumin ≥ 3.0 g/dL
  • Lactate dehydrogenase (LDH) < 2.5 X ULN
  • International normalized ratio/partial thromboplastin time (INR/PTT) ≤ 1.5 x ULN (unless subject is receiving anticoagulant therapy as long as prothrombin time (PT) or PTT is within therapeutic range of intended use of anticoagulants)
  • Thyroid stimulating hormone (TSH), free T4 (FT4), and free T3 (FT3) within normal ranges
  • Cortisol at 8 AM within normal ranges
  • Lipase and amylase < 3 ULN
  • Fasting plasma glucose ≤ 120 mg/dl or 6.7 mmol/L
  • Troponin within normal range

Who cannot join

  • History of invasive malignancy ≤ 3 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer,
  • Having received prior chemotherapy or targeted therapy within the past 12 months,
  • Has a prior history of DCIS and/or LCIS that was treated with any form of systemic, hormonal therapy, or radiotherapy to the ipsilateral breast; subjects who had their DCIS/LCIS treated only with surgery and/or contralateral DCIS treated with radiotherapy are allowed to enter the study,
  • Having received prior therapy with an anti-PD-1, anti-PD-L1, or anti-PD-L2 agents or with an agent directed to another co-inhibitory T-cell receptor (e.g., CTLA-4, OX-40, CD137),
  • Treatment with systemic immunostimulatory agents (including, but not limited to, interferons, interleukin-2) within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to inclusion,
  • Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (in dosing exceeding 10 mg daily of prednisone equivalent) or any other form of immunosuppressive medications (including prednisone, cyclophosphamide, azathioprine, methotrexate, thalidomide, and anti-tumor necrosis factor [anti-TNF] alpha agents) within 7 days prior to inclusion:
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  • Subjects who have received acute, low-dose, systemic immunosuppressant medications (e.g., a one-time dose of dexamethasone for nausea) may be enrolled in the study
  • The use of inhaled corticosteroids and mineralocorticoids is allowed,
  • Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment; subjects with eczema, psoriasis, lichen simplex chronicus, or vitiligo with dermatologic manifestations only are eligible if:
  • Rash must covers <10% of body surface area.
  • Disease is well controlled at baseline and requires only low-potency topical Corticosteroids and no acute exacerbations requiring psoralen plus ultraviolet A radiation, methotrexate, retinoids, biologic agents, oral calcineurin inhibitors, or oral corticosteroids occurred within the previous 12 months,
  • Has a known history of Human Immunodeficiency Virus (HIV),
  • Prior allogeneic stem cell or solid organ transplant,
  • Has a known history of active Bacillus Tuberculosis,
  • Patients with any other disease or illness which requires hospitalisation or is incompatible with the trial treatment are not eligible,
  • Pregnant women or breastfeeding or expecting to conceive within the projected duration of the study, from the inclusion visit until the end of the 3 years follow up. Men subjects who engage in heterosexual intercourse and refuse to use protocol-specified method(s) of contraception during trial treatments and for at least 6 months after the last dose of trial treatments,
  • Patients unable to comply with trial obligations for geographic, social, or physical reasons, or who are unable to understand the purpose and procedures of the trial,
  • Person deprived of their liberty or under protective custody or guardianship,
  • Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial.
  • Additional non-inclusion criteria for subjects of cohort 1:
  • Has cardiac dysfunction as defined by any of the following prior to inclusion:
  • History of NCI-CTCAE v5.0 Grade > 3 symptomatic congestive heart failure or New York Heart Association (NYHA) criteria Class II,
  • Angina pectoris requiring anti-anginal medication, serious cardiac arrhythmia not controlled by adequate medication, severe conduction abnormality, or clinically significant valvular disease,
  • Significant symptoms (≥ Grade 2) relating to left ventricular dysfunction or cardiac ischemia,
  • Has a known hypersensitivity (≥ Grade 3) to the components of the study therapy or its analogs,
  • Has received a live vaccine or live-attenuated vaccine within 30 days of the first dose of study treatment,
  • Concurrent active Hepatitis B virus (HBV; defined as HBsAg positive and/or detectable HBV DNA) and Hepatitis C virus (HCV; defined as anti-HCV Ab positive and detectable HCV RNA) infection,
  • Severe infections within 4 weeks prior to initiation of study treatment, including, hospitalization for complications of infection, bacteremia, or severe pneumonia,
  • Treatment with therapeutic oral or IV antibiotics within 2 weeks prior to initiation of study treatment; subjects receiving prophylactic antibiotics (e.g., for prevention of a urinary tract infection) are eligible,
  • Major surgical procedure other than for diagnosis within 4 weeks prior to initiation of study treatment or anticipation of need for a major surgical procedure during study treatment,
  • Has a history of (non-infectious) pneumonitis/interstitial lung disease that required steroids or has a current pneumonitis/interstitial lung disease,
  • Is currently participating in or has participated in an interventional clinical trial with an investigational compound or device within 4 weeks of the first dose of treatment in this current trial.

Trial locations and contacts

44 sites in 2 countries. Contact the study team or a site near you to ask about taking part.

Telma ROQUE, PhD contact

+33 (0) 1 80 50 12 92

etna@unicancer.fr

Sylvie Mijonnet contact

s-mijonnet@unicancer.fr

44 sites in 2 countries

France30 sites, 29 recruiting

  • CHU Amiens Picardie_Site Sud

    Amiens, 80054

    Aurélie MOREIRA, MD

    Aurélie MOREIRA, MD

    Recruiting

  • Institut Sainte Catherine

    Avignon, 84918

    Julien GRENIER

    Julien GRENIER, MD

    Recruiting

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109

    Thomas GRELLETY, MD

    Thomas GRELLETY, MD

    Recruiting

  • Institut Bergonié

    Bordeaux, 33000

    Maxime BRUNET, MD

    Maxime BRUNET, MD

    Not yet recruiting

  • Polyclinique Bordeaux Nord Aquitaine

    Bordeaux, 33077

    Nadine DOHOLLOU, MD

    Nadine DOHOLLOU, MD

    Recruiting

  • Centre François Baclesse

    Caen, 14000

    George EMILE, MD

    George EMILE, MD

    Recruiting

  • Pôle Santé Republique

    Clermont-Ferrand, 63000

    Lionel Moreau, MD

    Lionel MOREAU, MD

    Recruiting

  • Centre Jean Perrin

    Clermont-Ferrand, 63011

    Marie-Ange MOURET-REYNIER, MD

    Marie-Ange MOURET-REYNIER, MD

    Recruiting

  • Centre Georges-François Leclerc

    Dijon, 21000

    Isabelle DESMOULINS

    Isabelle DESMOULINS

    Not yet recruiting

  • Hôpital Franco-Britannique-Fondation Cognacq-Jay

    Levallois-Perret, 92300

    Nathalie PEREZ-STAUB, MD

    Nathalie PEREZ-STAUB, MD

    Not yet recruiting

  • CHU de Limoges

    Limoges, 87042

    Elise DELUCHE, MD

    Elise DELUCHE, MD

    Recruiting

  • Centre Léon Bérard

    Lyon, 69008

    Olivier TREDAN, MD

    Olivier TREDAN, MD

    Recruiting

  • Hopital Privé Jean Mermoz

    Lyon, 69008

    Olfa DERBEL, MD

    Olfa DERBEL, MD

    Recruiting

  • Institut Paoli-Calmettes

    Marseille, 13009

    Frédéric VIRET, MD

    Frédéric VIRET, MD

    Recruiting

  • Institut régional du Cancer de Montpellier

    Montpellier, 34298

    Véronique D'HONDT, MD

    Véronique D'HONDT, MD

    Not yet recruiting

  • Hôpital privé du confluent

    Nantes, 44200

    Dorothée CHOCTEAU-BOUJU, MD

    Dorothée CHOCTEAU-BOUJU, MD

    Recruiting

  • Centre Antoine Lacassagne

    Nice, 61000

    Jean-Marc FERRERO

    Jean-Marc FERRERO

    Recruiting

  • CHU de Nîmes

    Nîmes, 30029

    Frédéric FITENI, MD

    Frédéric FITENI, MD

    Recruiting

  • Centre Hospitalier de Pau

    Pau, 64046

    Kévin BOURCIER, MD

    Kévin BOURCIER, MD

    Recruiting

  • Hôpital Privé des côtes d'Armor

    Plérin, 22190

    Jérôme MARTIN-BABAU, MD

    Jérôme MARTIN-BABAU, MD

    Not yet recruiting

  • Hôpital NOVO

    Pontoise, 95300

    Rolande NGUEFACK

    Rolande NGUEFACK, MD

    Recruiting

  • Centre Hospitalier de Cornouaille

    Quimper, 29107

    Mathilde BUREAU

    Mathilde BUREAU, MD

    Recruiting

  • Clinique La Croix du Sud

    Quint-Fonsegrives, 31130

    Withdrawn

  • Institut Godinot

    Reims, 51100

    Christelle JOUANNAUD, MD

    Christelle JOUANNAUD, MD

    Recruiting

  • Centre Eugène Marquis

    Rennes, 35000

    Fanny LE DU, MD

    Fanny LE DU, MD

    Recruiting

  • CHU de Saint Etienne

    Saint-Etienne, 42055

    Alicia QUILEZ-CUTILLAS, MD

    Alicia QUILEZ-CUTILLAS, MD

    Recruiting

  • Institut Claudius Regaud

    Toulouse, 31059

    Florence DALENC, MD

    Florence DALENC

    Recruiting

  • CHU Bretonneau

    Tours, 37000

    Marie-Agnès BY, MD

    Marie-Agnès BY, MD

    Recruiting

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54519

    Anne KIEFFER, MD

    Anne KIEFFER, MD

    Recruiting

  • Gustave Roussy

    Villejuif, 94805

    Elie Rassy, MD

    Elie Rassy, MD

    Recruiting

Other trials in France

Spain14 sites, 14 recruiting

  • Hospital General Universitario Dr.Balmis

    Alicante

    José PONCE, MD, +34 965 933 513, joseponcelorenzo@hotmail.com

    José PONCE, MD

    Not yet recruiting

  • Ico Badalona

    Badalona, 08916

    Margeli VILA

    Margeli VILA, MD

    Not yet recruiting

  • Hospital Vall D'Hebrón

    Barcelona, 08035

    Mafalda OLIVEIRA, MD

    Mafalda OLIVEIRA, MD

    Not yet recruiting

  • Hospital Clinico Universitario Virgen de La Arrixaca

    El Palmar, 30120

    Pilar SANCHEZ HENAREJOS, MD

    Pilar SANCHEZ HENAREJOS, MD

    Not yet recruiting

  • Hospital Universitario Clinico San Cecilio

    Granada, 18016

    Maria Isabel BLANCAS, MD

    Maria Isabel BLANCAS, MD

    Not yet recruiting

  • Ico Hospitalet

    L'Hospitalet de Llobregat, 08908

    Sonia PERNAS, MD

    Sonia PERNAS, MD

    Recruiting

  • Complejo Asistencial Universitario de Leon

    León, 24071

    Maria MARTINEZ GARCIA, MD

    Maria MARTINEZ GARCIA, MD

    Not yet recruiting

  • Hu Arnau de Vilanova Lleida

    Lleida, 25198

    Serafin MORALES

    Serafin MORALES, MD

    Not yet recruiting

  • Hospital Ramon Y Cajal

    Madrid, 28034

    Elena LÓPEZ FLORES

    Elena LÓPEZ FLORES, MD

    Not yet recruiting

  • Hospital 12 de Octubre

    Madrid, 28041

    Manuel ALVA BIANCHI, MD

    Manuel ALVA BIANCHI, MD

    Not yet recruiting

  • Hospital Universitari Son Espases

    Palma de Mallorca, 07120

    Antonia PERELLÓ, MD

    Antonia PERELLÓ, MD

    Not yet recruiting

  • Hospital Sant Joan de Reus

    Reus, 43204

    Alba COCHS

    Alba COCHS, MD

    Not yet recruiting

  • Hospital Universitario Virgen Del Rocio

    Seville, 41013

    Monica CEJUELA

    Monica CEJUELA, MD

    Not yet recruiting

  • Hospital Clínico Valencia

    Valencia, 46010

    Juan Miguel CEJALVO

    Juan Miguel CEJALVO, MD

    Not yet recruiting

Other trials in Spain

About this study

Official title: Adjuvant Pembrolizumab and Chemotherapy or Surveillance in Early Triple Negative breAst Cancer With High Stromal Tumor-infiltrating Lymphocytes (TILs) Score

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.

Read the detailed description

(Neo)adjuvant chemotherapy in breast cancer is associated to long-term persistent QoL deterioration in patients with early breast cancer, with a greater negative impact in patients that were premenopausal at diagnosis. Because triple negative breast cancer (TNBC), which accounts for 10-20% of breast cancers, presents a poorer prognosis as compared to the other subtypes, international guidelines endorse the use of adjuvant chemotherapy from TNBC tumors measuring > 5 mm. Nevertheless, a number of retrospective studies have reported excellent prognosis for patients with small, lymph node-negative and high TILs TNBC, even without chemotherapy, with 5-year overall survival (OS) of 98%. Findings from multiple data sets consistently demonstrated that TILs represent a robust prognostic and predictive biomarker in early-stage TNBC, being now the first biological prognostic marker for TNBC included in several international guidelines for early-stage disease, such as 2019 St Gallen consensus conference and European Society for Medical Oncology (ESMO) Guidelines for early-stage breast cancer.

In clinical practice, oncologists have taken different approaches in patients with stage I TNBC. While some have de-escalated anthracyclines, other did not held back on the standard chemotherapy options with anthracyclines, taxanes, and cyclophosphamide. Based on unpublished data from the TNBC pooled analysis with sTILs on 2211 patients not treated by systematic therapy, performed at Gustave Roussy, the 5-year distant disease free-survival (DDFS) is 87%, 91%, and 93% for those with stage I and sTILs ≥ 30%, 50%, and 75%, respectively. Given these compelling findings from historical observations, it is reasonable to anticipate that the absolute benefit of chemotherapy would be modest among these patients as their tumors generally exhibit a favorable prognosis, resulting in reduced benefits with the use of adjuvant chemotherapy.

ETNA is a phase II, multicenter, biomarker-driven study that is designed to characterize the clinical course of patients with stage I TNBC and sTILs ≥ 30%.

ETNA includes patients with stage I and sTILs ≥ 30% TNBC in 2 cohorts:

  • Cohort 1 will include patients age > 40 years with 30% ≤ sTILs < 50% and those aged ≤ 40 years with 30% ≤ sTILs < 75%. Patients will receive 9 cycles of adjuvant pembrolizumab 200 mg every three weeks for 9 cycles and Paclitaxel 80 mg/m² weekly for 12 cycles.
  • Cohort 2 will include patients aged > 40 years with sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75% who will undergo standard surveillance (no adjuvant systemic treatments).
Being tested
Pembrolizumab 25 mg/ml, Paclitaxel injection
Keywords
Breast cancer, De-escalation, Immunotherapy, Chemotherapy
Medical subject headings
Triple Negative Breast Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pembrolizumab 25 mg/mlDrug

    Also called keytruda

    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.

  • Paclitaxel injectionDrug

    Also called Taxol

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

Study groups in NCT06078384
Study groupRoleWhat they receive
Cohort 1-Pembrolizumab plus PaclitaxelExperimentalPembrolizumab will be administered at a fixed dose of 200 mg every 3 weeks (Q3W), with a total of 9 cycles and Paclitaxel 80 mg/m² weekly for 12 cycles
Receives: Drug: Pembrolizumab 25 mg/ml; Drug: Paclitaxel injection
Cohort 2-ObservationNo interventionNo treatment will be administered, patients will undergo standard surveillance every 6 months according to local practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Distant disease-free survival (DDFS)

    Distant disease-free survival is defined as the delay between date of inclusion and distant tumor relapse, second cancer, or death from any cause, whichever occurs first.

    Measured: 5 year

Secondary outcomes (8)

  1. Invasive disease-free survival (IDFS)

    Invasive disease-free survival is defined as the delay between date of inclusion and invasive breast tumor recurrence, distant recurrence, second cancer, or death from any cause, whichever occurs first.

    Measured: From inclusion up to 5 year

  2. Distant recurrence-free survival (DRFS)

    Distant recurrence-free survival is defined as the delay between date of inclusion and distant recurrence of breast cancer or death from any cause, whichever occurs first.

    Measured: From inclusion up to 5 year

  3. Overall survival (OS)

    The overall survival is the length of time from inclusion that patients enrolled in the study are still alive.

    Measured: From inclusion to death from any cause, up to 5 year

  4. Incidence of Adverse Events

    The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders.

    Measured: Throughout study completion, up to 5 year

  5. Quality of life questionnaire - Core 30 (QLQ-C30)

    Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials.

    The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease.

    All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level.

    Measured: At baseline, every 3 weeks for 6 months then every 6 months up to 5 years

  6. Quality of Life Questionnaire - Breast cancer module (QLQ-BR23)

    This EORTC breast cancer specific questionnaire is intended to supplement the QLQ-C30.

    The QLQ-BR23 contains 23 items incorporating five multi-item scales to assess systemic therapy side effects, arm symptoms, breast symptoms, body image and sexual functioning. In addition, single items assess sexual enjoyment, hair loss and future perspective. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale. For all items but sexual functioning and sexual enjoyment, higher scores indicate more severe symptoms.

    Measured: At baseline, every 3 weeks for 6 months then every 6 months up to 5 years

  7. Quality of Life Questionnaire - Cancer-related fatigue (QLQ-FA12)

    This EORTC cancer related fatigue questionnaire is intended to supplement the QLQ-C30.

    The QLQ-FA12 contains 12 items organized in three subscales: physical fatigue (5 items), emotional fatigue (3 items), and cognitive fatigue (2 items). The remaining two items serve as global indicators for interference of fatigue with daily activities and social sequelae of fatigue. All items are rated on a four-point Likert-type scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), and are linearly transformed to a 0-100 scale with higher scores indicating greater degree of fatigue.

    Measured: At baseline, every 3 weeks for 6 months then every 6 months up to 5 years

  8. Hospital anxiety and depression scale (HADS)

    The HADS is a 14 items questionnaire: 7 items related to anxiety and 7 items related to depression scored on a scale. Scores for items in each subscale of the HADS are summed to produce an anxiety score (HADS-A) or a depression score (HADS-D), or can be added to produce a total score corresponding to emotional distress (HADS-T). Each item is rated on a 4-point Likert scale (1 = "not at all", 2 = "a little", 3 = "quite a bit", and 4 = "very much"), for a total score ranging from 0-21 for each subscale. The entire scale (emotional distress) range from 0 to 42, with higher scores indicating more distress.

    Measured: At baseline, every 3 weeks for 6 months then every 6 months up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Oct 2023
  2. Study start27 Dec 2024
  3. Primary completion1 Jan 2032 (estimated)
  4. Study completion1 Jan 2032 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Model description
Cohort of patients with T1b/c N0 M0 TNBC aged \> 40 years with 30% ≤ sTILs \< 50% and those aged ≤ 40 years with 30% ≤ sTILs \< 75%: Pembrolizumab will be administered at a fixed dose of 200 mg every 3 weeks (Q3W), with a total of 9 cycles and Paclitaxel 80 mg/m² weekly for 12 cycles at adjuvant phase of the treatment; Cohort of patients with T1b/c N0 M0 TNBC aged \> 40 years and sTILs ≥ 50% and those aged ≤ 40 years with sTILs ≥ 75%: No treatment will be administered. These patients will undergo standard surveillance every 6 months according to local practice.
Masking
None (open label)
Enrolment
354 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06078384
Sponsor's protocol ID
UC-BCG-2213
Other IDs
2023-504620-26-00, 2023
Acronym
ETNA
Status last verified
Jul 2026
First submitted
5 Oct 2023
Last updated
24 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab 25 mg/ml and Paclitaxel injection in people with Triple-negative Breast Cancer, run by UNICANCER at 44 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 38 inclusion and 32 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 24 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in France, Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Telma ROQUE, PhD (+33 (0) 1 80 50 12 92, etna@unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Distant disease-free survival (DDFS) (time frame: 5 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06078384.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2026.

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