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

NCT06636591 | Recruiting

• 1 other identifier: MTT-BC-002
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer Female; HER2-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Assessment of immune activating response

  * 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

  up to 28 weeks

Secondary Outcomes (1)

• CTCAE scale (V4.0)

  up to 28 weeks

Study Arms (2)

Triple-negative Breast Cancer with Non-immunomodulatory Subtype

EXPERIMENTAL

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

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

EXPERIMENTAL

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

Interventions

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

Drugs was given a few days after multimodal thermal therapy

Triple-negative Breast Cancer with Non-immunomodulatory Subtype

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

Drugs was given a few days after multimodal thermal therapy

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female，age 18-70 years.
• Histologically confirmed invasive cancer of the breast, and patients meeting cT2-4N+M0 criteria;
• TNBC non-immunoregulation subtype or HR+/HER2- status were measured by immunohistochemistry (IHC);
• At least one measurable lesion according to RECIST 1.1 criteria;
• 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);
• LVEF ≥55%;
• Eastern Cooperative Oncology Group (ECOG) performance status 0-1;
• 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;
• Ability to understand and willingness to sign a written informed consent.

You may not qualify if:

• Previous cytotoxic chemotherapy, endocrine therapy, biological therapy or radiotherapy for any reason;
• Patients with New York Heart Association (NYHA) grade II or above heart disease (including grade II);
• Patients with severe systemic infections or other serious diseases;
• Patients with known allergy or intolerance to the study drug or its excipients;
• Other malignant tumors in the past 5 years, except cured cervical carcinoma in situ and non-melanoma skin cancer;
• Pregnant or lactating patients of childbearing age who refused to take appropriate contraceptive measures during the course of the study;
• Participated in other trial studies within 30 days before the administration of the first dose of the study drug;
• Endocrine system disorders;
• Patients who were judged by the investigator to be unsuitable for this study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Central Study Contacts

Zhimin Shao, M.D

CONTACT

: +86-021-64175590; zhimingshao@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 29, 2024
• First Posted: October 10, 2024
• Study Start: November 18, 2024
• Primary Completion: February 7, 2025
• Study Completion (Estimated): October 7, 2026
• Last Updated: November 15, 2024

Record last verified: 2024-11

Locations

CN (1)