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.
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,
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),
Parallel
Pembrolizumab 25 mg/ml
DrugPembrolizumab 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 injection
DrugInjectable solution for IV administration. Dose of 80 mg/m² weekly.
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.
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.
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.
Overall survival (OS)
The overall survival is the length of time from inclusion that patients enrolled in the study are still alive.
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.
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UNICANCER
Lead sponsor
MSD France
Collaborator
SOLTI Breast Cancer Research Group
Collaborator
Gustave Roussy, Cancer Campus, Grand Paris
Collaborator
Vall Hebron Insitut Recerca
Collaborator
