Clinical trial · Interventional
Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer
A Prospective, Open-label, Single-center, Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer
NCT06636591CI-TRIAL-00117257completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer Female | — | UNRESOLVED | — |
| HER2-negative Breast Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin | Combination Product | — | UNRESOLVED |
| Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin | Combination Product | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Triple-negative Breast Cancer with Non-immunomodulatory Subtype
- interventionNames
- Combination Product: Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin
- type
- EXPERIMENTAL
- label
- Hormone Receptor-positive (HR+) and HER2-negative (HER2-)
- interventionNames
- Combination Product: Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin
Primary outcomes (1)
- measure
- Assessment of immune activating response
- timeFrame
- up to 28 weeks
- description
- * Proportion of subjects with immune response to combination therapy detected by biomarkers in peripheral blood samples * Evaluate the infiltration of immune cells in tumor areas and adjacent tissues
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 70 Years
Show eligibility criteria text
Inclusion Criteria: 1. Female，age 18-70 years. 2. Histologically confirmed invasive cancer of the breast, and patients meeting cT2-4N+M0 criteria; 3. TNBC non-immunoregulation subtype or HR+/HER2- status were measured by immunohistochemistry (IHC); 4. At least one measurable lesion according to RECIST 1.1 criteria; 5. Normal organ and marrow function: Hemoglobin (HB) ≥90 g/L (No blood was transfused within 14 days), Absolute neutrophil count ≥ 1500/μL, Platelets ≥ 75,000/μL, Total bilirubin ≤ 1.5 x ULN), aspartate aminotransferase (AST) (SGOT) and alanine aminotransferase (ALT) (SGPT) ≤ 3 x ULN, creatinine \< 1 x ULN, endogenous creatinine clearance \> 50 ml/min (Cockcroft-Gault formula); 6. LVEF ≥55%; 7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1; 8. Non-pregnant and non-lactating, fertile female subjects were required to use a medically approved contraceptive method for the duration of the study treatment and at least 3 months after the last use of the study drug; 9. Ability to understand and willingness to sign a written informed consent. Exclusion Criteria: 1. Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason; 2. Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II); 3. Patients with severe systemic infections or other serious diseases; 4. Patients with known allergy or intolerance to the study drug or its excipients; 5. Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer; 6. Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study; 7. Participated in other trial studies within 30 days before the administration of the first dose of the study drug; 8. Endocrine system disorders; 9. Patients who were judged by the investigator to be unsuitable for this study.
References
Publications (0)
Data not yet available
No reference posted for this study.