OncoMatch/Clinical Trials/NCT06078384
Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC
Is NCT06078384 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Pembrolizumab 25 mg/ml and Paclitaxel for triple-negative breast cancer.
Treatment: Pembrolizumab 25 mg/ml · Paclitaxel — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Triple-Negative Breast Cancer
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative (HER2 negativity is defined by local laboratory assessment using in situ hybridization and immunohistochemistry assays as per ASCO/CAP criteria)
HER2 negativity is defined by local laboratory assessment using in situ hybridization and immunohistochemistry assays as per ASCO/CAP criteria
Required: ESR1 negative (ER negativity is defined by local laboratory assessment < 10% using immunohistochemistry assays)
ER/PgR negativity is defined by local laboratory assessment < 10% using immunohistochemistry assays
Required: PR (PGR) negative (PgR negativity is defined by local laboratory assessment < 10% using immunohistochemistry assays)
ER/PgR negativity is defined by local laboratory assessment < 10% using immunohistochemistry assays
Disease stage
Required: Stage PT1B, PT1C (AJCC TNM stage-8th version)
Histologically confirmed and radically removed pT1b/c N0M0 TNBC as defined according to AJCC TNM stage-8th version
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: chemotherapy
Exception: within the past 12 months
Having received prior chemotherapy or targeted therapy within the past 12 months
Cannot have received: targeted therapy
Exception: within the past 12 months
Having received prior chemotherapy or targeted therapy within the past 12 months
Cannot have received: anti-PD-1 therapy
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)
Cannot have received: systemic immunostimulatory agents (interferons, interleukin-2)
Exception: within 4 weeks or 5 half-lives of the drug, whichever is longer, prior to inclusion
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
Cannot have received: systemic, hormonal therapy or radiotherapy to the ipsilateral breast for DCIS/LCIS
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
Lab requirements
Blood counts
ANC ≥ 1,500 /µL; Platelets ≥ 100,000 /µL; Hemoglobin ≥ 9 g/dL; INR/PTT ≤ 1.5 x ULN (unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants)
Kidney function
Creatinine clearance ≥ 30 mL/min for subject with creatinine levels > 1.5 x institutional ULN
Liver function
Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST and ALT ≤ 2.5 x ULN; Albumin ≥ 3.0 g/dL; Lipase and amylase < 3 ULN
Cardiac function
LVEF ≥ 50% as assessed by echocardiogram or cardiac scintigraphy; Troponin within normal range
Left ventricular ejection fraction (LVEF) of ≥ 50% as assessed by echocardiogram or cardiac scintigraphy; Adequate organ function: 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 ULN; Total bilirubin ≤ 1.5 x ULN or direct bilirubin ≤ ULN for subjects with total bilirubin levels > 1.5 ULN; AST and ALT ≤ 2.5 x ULN; Albumin ≥ 3.0 g/dL; LDH < 2.5 X ULN; INR/PTT ≤ 1.5 x ULN (unless subject is receiving anticoagulant therapy as long as PT or PTT is within therapeutic range of intended use of anticoagulants); TSH, FT4, and 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
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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