CMP-001 and Pre-operative Stereotactic Body Radiation Therapy (SBRT) in Early Stage Triple Negative Breast Cancer (TNBC)
Status:
Recruiting
Trial end date:
2025-12-01
Target enrollment:
Participant gender:
Summary
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).