This multicenter phase II study evaluates a de-escalation strategy of neoadjuvant chemo-immunotherapy in patients with stage II early triple-negative breast cancer and tumor-infiltrating lymphocytes (TILs) ≥ 30%. Patients will receive 12 weeks of neoadjuvant treatment with carboplatin, paclitaxel, and pembrolizumab.
The primary objective is to assess the efficacy of this treatment strategy by evaluating the proportion of patients with no suspected residual tumor on breast MRI and biopsy after 12 weeks of neoadjuvant therapy, confirmed by pathological examination of the surgerey sample.
Male or female aged 18 years or older.
Signed informed consent for study participation.
Histologically and/or cytologically confirmed invasive triple-negative breast adenocarcinoma (ER and PR < 10%, HER2-negative), documented on all tumor samples.
Stage II disease: T2-T3N0M0 or T1-T2N1M0.
Metastatic disease at diagnosis.
Relapse of a previous breast cancer.
Bilateral breast cancer.
Invasive breast adenocarcinoma with ER and PR > 10% and/or HER2-positive disease.
Single group
Pembrolizumab
DrugPembrolizumab administered in combination with carboplatin and paclitaxel as neoadjuvant treatment ( 12 weeks) for stage II early triple-negative breast cancer.
Proportion of Patients Without Residual Tumor After 12 Weeks of Neoadjuvant Treatment
Proportion of patients with no suspected residual tumor on breast MRI and biopsy after 12 weeks of neoadjuvant treatment, confirmed by pathological examination at surgery.
Event-Free Survival (EFS)
Event-free survival.
Overall Survival (OS)
Overall survival.
Residual Cancer Burden (RCB)
Residual Cancer Burden (RCB) will be calculated as a continuous index combining pathological measurements of the primary tumor (size and cellularity) and nodal metastases (number and size), according to the method described by Symmans et al. RCB-0 is defined as pathological complete response (pCR; ypT0/Tis ypN0). RCB-1 corresponds to minimal residual disease, RCB-2 to moderate residual disease, and RCB-3 to extensive residual disease.
Treatment-Related Toxicity
Toxicity related to chemotherapy and immunotherapy will be assessed according to the occurrence and severity of adverse events of interest associated with chemotherapy and pembrolizumab treatment.Incidence of Adverse Events
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
