RecruitingNot ApplicableNCT06636591

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


Sponsor

Fudan University

Enrollment

14 participants

Start Date

Nov 18, 2024

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This pilot study tests a combination of chemotherapy, immunotherapy, and heat therapy (thermal therapy) given before surgery in women with HER2-negative breast cancer. Researchers want to see if adding heat treatment to standard chemotherapy and immunotherapy improves outcomes before surgery. **You may be eligible if...** - You are a woman between 18 and 70 years old - You have been diagnosed with invasive HER2-negative breast cancer (either triple-negative or hormone receptor positive) - Your cancer is locally advanced (stage cT2–4N+M0) - You have not received any prior chemotherapy, radiation, or hormonal therapy for this cancer - Your heart, blood counts, and organ function are within acceptable ranges **You may NOT be eligible if...** - You have previously received any anti-cancer treatment - You have a serious heart condition (NYHA Grade II or above) - You have severe infections or other serious illnesses - You are pregnant or breastfeeding - You have had another cancer in the past 5 years (except certain cured skin or cervical cancers) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

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

Drugs was given a few days after multimodal thermal therapy

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

Drugs was given a few days after multimodal thermal therapy


Locations(1)

Breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

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NCT06636591


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