Combining chemotherapy, immunotherapy, and 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

This study is testing a new treatment approach that combines chemotherapy, immunotherapy, and heat therapy to see if it helps people with operable HER2-negative breast cancer.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 14 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06636591 on ClinicalTrials.gov

What this trial studies

This pilot study aims to evaluate the effectiveness of combining neoadjuvant chemotherapy with immunotherapy and multimodal thermal therapy in patients with operable HER2-negative breast cancer. Participants will be divided into groups based on molecular typing and subtyping, receiving treatments that include cryoablation and radiofrequency heating to enhance immune responses against the tumor. The study seeks to assess the potential immunologic effects of this combination therapy and its ability to induce systemic anti-tumor immunity. Data collected will inform future clinical studies.

Who should consider this trial

Good fit: Ideal candidates are females aged 18-70 with histologically confirmed invasive HER2-negative breast cancer and specific measurable lesions.

Not a fit: Patients with HER2-positive breast cancer or those with significant comorbidities affecting treatment tolerance may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could improve treatment outcomes for patients with HER2-negative breast cancer by enhancing immune responses and tumor destruction.

How similar studies have performed: While the combination of therapies is innovative, similar approaches in other studies have shown promise in enhancing immune responses in cancer treatment.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality

• Breast cancer institute of Fudan University Cancer Hospital — Shanghai, Shanghai Municipality, China (Recruiting)

Study contacts

• Study coordinator: Zhimin Shao, M.D

Conditions Breast Cancer Female; HER2-negative Breast Cancer