Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer

NCT ID: NCT06636591

Last Updated: 2024-11-15

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 14 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-18
• Study Completion Date: 2026-10-07

Brief Summary

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.

Detailed Description

Local tumor destruction with non-surgical ablation (NSA, cryoablation or radiofrequency) induces inflammation and releases antigens that can activate tumor-specific immune responses.

Pre-clinically, we demonstrated that multimodal thermal therapy (MTT) as an integrated treatment modality of cryotherapy and radiofrequency heating, can effectively activate systemic and long-lasting antitumor immunity.

In this pilot study, patients with operable HER2-negative breast cancer were designed to receive a combination of MTT, immunotherapy and neoadjuvant chemotherapy. Potential favorable intra-tumoral and systemic immunologic effects were assessed with the combination, revealing the possibility for induced and synergistic anti-tumor immunity with this strategy.

Conditions

Breast Cancer Female; HER2-negative Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Triple-negative Breast Cancer with Non-immunomodulatory Subtype

Group Type: EXPERIMENTAL

Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin

Intervention Type: COMBINATION_PRODUCT

Drugs was given a few days after multimodal thermal therapy

Hormone Receptor-positive (HR+) and HER2-negative (HER2-)

Group Type: EXPERIMENTAL

Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin

Intervention Type: COMBINATION_PRODUCT

Drugs was given a few days after multimodal thermal therapy

Interventions

Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin

Drugs was given a few days after multimodal thermal therapy

Intervention Type: COMBINATION_PRODUCT

Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Goserelin

Drugs was given a few days after multimodal thermal therapy

Intervention Type: COMBINATION_PRODUCT

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Fudan University

OTHER

Sponsor Role: lead

Responsible Party

Zhimin Shao

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Zhimin Shao, M.D

Role: CONTACT

zhimingshao@yahoo.com

: +86-021-64175590 ext. 88807

Facility Contacts

Zhimin Shao, M.D

Role: primary

zhimingshao@yahoo.com

86-21-64175590

Other Identifiers

MTT-BC-002

Identifier Type: -

Identifier Source: org_study_id