Microwave Ablation Combined With Camrelizumab in the Treatment of Early Breast Cancer

NCT04805736 | Completed Phase 2

• 1 other identifier: MA-BC-Ⅱ-021
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Ablative therapy, as a local treatment modality for tumors, has an immune activating effect. To explore the synergistic effect of microwave ablation combined with PD-1 inhibitors, this prospective, open-label, multi-cohort, single-center clinical study was conducted. To compare the feasibility and safety of preoperative microwave ablation alone, with or without camrelizumab in patients with early newly diagnosed breast cancer.

Conditions

Breast Cancer

Keywords

Ablation; PD-1; Immunotherapy

Outcome Measures

Primary Outcomes (1)

• Safety of Microwave Ablation Combined With Camrelizumab

  Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0

  3 months

Secondary Outcomes (4)

• Complete ablation rate

  1 day

• Negative predictive value of ultrasound

  1 day

• Assessment of Immunogenicity

  3 months

• Breast self evaluation

  3 months

Study Arms (3)

Microwave Ablation alone

EXPERIMENTAL

Microwave Ablation+ Breast Surgery

Procedure: Microwave Ablation; Procedure: Breast Surgery

Camrelizumab alone

EXPERIMENTAL

Camrelizumab+ Breast Surgery

Drug: Camrelizumab; Procedure: Breast Surgery

Microwave Ablation & Camrelizumab

EXPERIMENTAL

Microwave Ablation + Camrelizumab + Breast Surgery

Procedure: Microwave Ablation; Drug: Camrelizumab; Procedure: Breast Surgery

Interventions

Microwave Ablation PROCEDURE

Image-guided microwave ablation 7-10 days prior to surgery

Microwave Ablation & Camrelizumab; Microwave Ablation alone

Camrelizumab DRUG

Camrelizumab 200 mg was given a few days after microwave ablation

Also known as: SHR-1210

Camrelizumab alone; Microwave Ablation & Camrelizumab

Breast Surgery PROCEDURE

Standard of care breast conserving surgery or radical mastectmoy

Camrelizumab alone; Microwave Ablation & Camrelizumab; Microwave Ablation alone

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female.
• Age 20-65 years.
• Invasive carcinoma confirmed by core biopsy.
• Newly diagnosed breast cancer patients, without adjuvant therapy.
• Imaging findings showed a single breast tumor with a maximum diameter of 3 cm, no distant metastasis, and no invasion of the skin and chest wall.
• Systematic ultrasound is able to visualize lesions.
• Surgical treatment was planned.
• The functional level of major organs must meet the following requirements:
• blood routine: neutrophil (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (Hb) ≥ 90 g/L;
• blood biochemistry: total bilirubin (TBIL) ≤ upper limit of normal (ULN); alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 1.5 × ULN; alkaline phosphatase ≤ 2.5 × ULN; blood urea nitrogen (BUN) and creatinine (Cr) ≤ 1.5 × ULN;
• coagulation: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
• Heart: left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography (ECHO) or multigated acquisition (MUGA).
• Thyroid function: thyroid stimulating hormone (TSH) ≤ ULN; if abnormal, T3 and T4 levels should be investigated, and normal T3 and T4 levels can be included.
• Urinalysis: urine protein \< 2 +, if urine protein ≥ 2 +, 24-hour urine protein quantification must show protein ≤ 1 g.
• Voluntarily participate in this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.

You may not qualify if:

• Tumor involving skin, ulceration, inflammatory breast cancer patients
• Fatty breast cancer.
• Tumors on the deep surface of areolar region
• KPS score \< 70, or ECOG score \> 2
• Patients with a history of concomitant collagen connective tissue disease, or any active autoimmune disease or autoimmune disease.
• Prior radiotherapy or prior use of investigational drugs or other immunosuppressive agents
• Heart, brain, lung, kidney and other vital organ failure, liver and kidney dysfunction;
• Uncorrectable severe coagulopathy
• Patient is pregnant or lactating
• Poor glycemic control in diabetes
• Patients with foreign body implantation around the tumor
• Patients with severe scars on the skin of the treatment area (protruding from the skin surface, width ≥ 1 cm)
• History of chronic immunosuppression, prior immunotherapy, recent vaccination (\< 4 weeks)
• Human immunodeficiency virus (HIV) infection, active hepatitis B (hepatitis B indicates antigen positive and HBV DNA ≥ 500 IU/ml), hepatitis C (hepatitis C antibody positive and HCV-RNA above the lower limit of detection of the analytical method).
• Concurrent medical conditions that, in the judgment of the investigator, would jeopardize the subject's safety, could confound the study results, or affect the subject's completion of this study.

Sponsors & Collaborators

• The First Affiliated Hospital with Nanjing Medical University: lead
• Jiangsu HengRui Medicine Co., Ltd.: collaborator

Study Sites (1)

the First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, China

Location

Related Publications (1)

• Pan H, Yu M, Tang X, Mao X, Liu M, Zhang K, Qian C, Wang J, Xie H, Qiu W, Ding Q, Wang S, Zhou W. Preoperative single-dose camrelizumab and/or microwave ablation in women with early-stage breast cancer: A window-of-opportunity trial. Med. 2024 Apr 12;5(4):291-310.e5. doi: 10.1016/j.medj.2024.01.015. Epub 2024 Feb 27.

  PMID: 38417440 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

camrelizumab; Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mastectomy; Surgical Procedures, Operative

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 10, 2021
• First Posted: March 18, 2021
• Study Start: March 25, 2021
• Primary Completion: April 30, 2023
• Study Completion: April 30, 2023
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

CN (1)