Actively Recruiting
Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer
Led by Fudan University · Updated on 2024-11-15
14
Participants Needed
1
Research Sites
98 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Female, age 18-70 years
- Histologically confirmed invasive breast cancer meeting cT2-4N+M0 criteria
- Triple-negative breast cancer non-immunoregulation subtype or hormone receptor positive/HER2-negative status by immunohistochemistry
- At least one measurable lesion according to RECIST 1.1 criteria
- Normal organ and marrow function with specified lab value thresholds
- Left ventricular ejection fraction (LVEF) of 55% or higher
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Non-pregnant and non-lactating; fertile females must use approved contraception during treatment and for 3 months after
- Ability to understand and sign informed consent
You will not qualify if you...
- Previous cytotoxic chemotherapy, endocrine therapy, biological therapy, or radiotherapy
- New York Heart Association grade II or higher heart disease
- Severe systemic infections or other serious diseases
- Known allergy or intolerance to study drugs or excipients
- Other malignant tumors within past 5 years except cured cervical carcinoma in situ and non-melanoma skin cancer
- Pregnant or lactating and not using appropriate contraception during the study
- Participation in other clinical trials within 30 days before first dose
- Endocrine system disorders
- Investigator judgment of unsuitability for study
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Breast cancer institute of Fudan University Cancer Hospital
Shanghai, Shanghai Municipality, China, 200032
Actively Recruiting
Research Team
Z
Zhimin Shao, M.D
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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