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Efti in Patients With Hormone Receptor Positive/HER2-neg Breast Cancer

StatusNot Yet Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Start date: May 1, 2026 to Sep 1, 2026v5
  2. Notable Start date: Jan 2, 2026 to May 1, 2026v4
  3. Notable Start date: Nov 1, 2025 to Jan 2, 2026v3
  4. Notable Start date: Sep 2025 to Nov 1, 2025v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this interventional study is to determine pathological complete response (pCR) after neoadjuvant chemotherapy (NAC) and Efti treatment. This is a prospective single arm interventional trial in patients with early-stage HR+/HER2 -ve breast cancer (Stage I-III) who are eligible for neoadjuvant chemotherapy (NAC). Enrolled patients will be treated with single agent efti for 3 weeks and then start NAC in combination with efti. There are 2 standard NAC usually used and will be determined by treating physician prior to starting on this trial.
Trial Details
NCT Number NCT07102940
Lead Sponsor George Washington University
Collaborators: Immutep S.A.S.
Conditions
(from sponsor)
Breast Cancer, HER 2 Negative Breast Cancer, HR Positive/HER-2 Negative Breast Cancer, Stage 1-3
Related terms Breast Neoplasms, Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov