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Reduction of Neoadjuvant Treatment in Early Triple-Negative Breast Cancer

Study acronym: DECREASE
StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Study First Submitted
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.
Trial Details
NCT Number NCT07857486
Lead Sponsor Institut Paoli-Calmettes
Conditions
(from sponsor)		 Early Triple-Negative Breast Cancer
Related terms Triple Negative Breast Neoplasms
Enrollment 84 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov