Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer
- Sponsor
- Fudan University
- Study ID
- NCT06636591
- Status
- Recruiting
Conditions
- Breast Cancer Female
- HER2-negative Breast Cancer
Eligibility Criteria
- Sex
- FEMALE
- Age
- 18 Years - 70 Years
- Healthy Volunteers
- Not accepted
Interventions
- Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin — COMBINATION_PRODUCTDrugs was given a few days after multimodal thermal therapy
- Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin — COMBINATION_PRODUCTDrugs was given a few days after multimodal thermal therapy
Study Details
In this study, breast cancer (BC) patients eligible for inclusion will be divided into two groups according to molecular typing and subtyping, which combined immunotherapy and multimodal thermal therapy with conventional neoadjuvant chemotherapy, to explore methods of immune induction for BC, enhance the efficacy of immunotherapy, and accumulate data for subsequent stages of clinical study.
Key Dates
- Start date
- Nov 18, 2024
- Status verified
- Nov 2024
- Primary completion
- Feb 7, 2025
- Completion
- Oct 7, 2026
Study Design
- Enrollment
- 14 participants (estimated)
- Allocation
- NON_RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- TREATMENT
Arms
- Experimental: Triple-negative Breast Cancer with Non-immunomodulatory Subtype
- Experimental: Hormone Receptor-positive (HR+) and HER2-negative (HER2-)
Primary Outcome Measure
Assessment of immune activating response [ Time Frame: up to 28 weeks ]
Central Contacts
- Zhimin Shao, M.D: +86-021-64175590
Related Studies
- I-SPY TRIAL: Neoadjuvant and Personalized Adaptive Novel Agents to Treat Breast CancerPHASE2 · Recruiting · QuantumLeap Healthcare Collaborative · Birmingham, Alabama
- Effects of Chemotherapy on Cognitive Function in Breast Cancer Patients & Non-Cancer Control Subjects With Optional Sub-Study Research Brain MRIRecruiting · University of Rochester · Rochester, New York
- GammaPod Registry and Quality of Life NomogramRecruiting · University of Maryland, Baltimore · Bel Air, Maryland
- SHARON: A Clinical Trial for Metastatic Cancer Using Chemotherapy and Patients' Own Stem CellsPHASE1 · Recruiting · General Oncology, Inc. · Boston, Massachusetts