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Trial Title:
Pilot Study of Neoadjuvant Chemotherapy Combined With Immunotherapy and Multimodal Thermal Therapy for HER2-negative Breast Cancer
NCT ID:
NCT06636591
Condition:
Breast Cancer Female
HER2-negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Paclitaxel
Albumin-Bound Paclitaxel
Cyclophosphamide
Carboplatin
Epirubicin
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Combination Product
Intervention name:
Device: Multimodal Tumor Thermal Therapy System Drug: Camrelizumab Drug: Nab paclitaxel Drug: Carboplatin Drug: Epirubicin Drug: Cyclophosphamide
Description:
Drugs was given a few days after multimodal thermal therapy
Arm group label:
Multimodal Thermal Therapy & Camrelizumab & Neoadjuvant Chemotherapy
Intervention type:
Combination Product
Intervention name:
Device: Multimodal Tumor Thermal Therapy System Drug: SHR1316 Drug: Nab paclitaxel Drug: Carboplatin
Description:
Drugs was given a few days after multimodal thermal therapy
Arm group label:
Multimodal Thermal Therapy & SHR1316 & Neoadjuvant Chemotherapy
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.
Criteria for 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.
Gender:
Female
Minimum age:
18 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Breast cancer institute of Fudan University Cancer Hospital
Address:
City:
Shanghai
Zip:
200032
Country:
China
Contact:
Last name:
Zhimin Shao, M.D
Phone:
86-21-64175590
Email:
zhimingshao@yahoo.com
Start date:
October 8, 2024
Completion date:
October 7, 2026
Lead sponsor:
Agency:
Fudan University
Agency class:
Other
Source:
Fudan University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06636591
