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CMP-001 and Pre-operative Stereotactic Body Radiation Therapy (SBRT) in Early Stage Triple Negative Breast Cancer (TNBC)

StatusActive, Not Recruiting
PhasePhase 2
Started
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Record status
This record was last updated February 27, 2025 (before its estimated December 2025 completion). Its status may not reflect the trial's current state.

Record History

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  1. Primary completion date: Sep 2023 to Dec 2025v3 Show 7 more changesShow less
    • Trial status: Recruiting to Active, Not Recruiting
    • Study completion date: Dec 2025 to Dec 2027
    • Start date: Apr 8, 2021 to Apr 7, 2021
    • Eligibility criteria shortened, about 60 words
    • Secondary endpoints: 10 to 11
    • Study description expanded, about 9 words
    • Site details revised
  2. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Apr 2021 to Apr 8, 2021
    • Eligibility criteria revised
    • Study description revised
    • Site details revised
  3. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
This is an open-label, randomized, window-of-opportunity phase 2 clinical study evaluating the biological activity of preoperative Stereotactic Body RadioTherapy (SBRT) alone (Arm 1), and combined with subcutaneous (SC) followed by intra-tumoral (IT) administrations of CMP-001 (Arm 2), in subjects with early stage TNBC. Safety and efficacy of the treatments are also examined. The main hypothesis that the study treatment induces an increase in stromal tumor infiltrating lymphocytes (sTILs) will be explored in each arm separately. The study is designed as a randomized selection study, with randomization used to address patient selection bias while each arm is run as an independent study. No formal statistical comparison between the two arms is planned. 40 patients will be equally (1:1) randomized in this study (20 per arm), stratified into two groups according to primary treatment strategy (upfront surgery versus neoadjuvant chemotherapy).
Trial Details
NCT Number NCT04807192
Lead Sponsor Centre Hospitalier Universitaire Vaudois
Conditions
(from sponsor)		 Triple Negative Breast Cancer
Related terms Triple Negative Breast Neoplasms
Enrollment 40 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov