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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Procedure: Microwave Ablation; Drug: Camrelizumab; Procedure: Breast Surgery

• Registration Number: NCT04805736
• Lead Sponsor: The First Affiliated Hospital with Nanjing Medical University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-03-10
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-18
• Study Start: 2021-03-25
• Primary Completion: 2023-04-30
• Study Completion: 2023-04-30
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-03
• Last Update Posted: 2024-01-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

1. Female.

2. Age 20-65 years.

3. Invasive carcinoma confirmed by core biopsy.

4. Newly diagnosed breast cancer patients, without adjuvant therapy.

5. 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.

6. Systematic ultrasound is able to visualize lesions.

7. Surgical treatment was planned.

8. The functional level of major organs must meet the following requirements:

   1. blood routine: neutrophil (ANC) ≥ 1.5 × 109/L; platelet count (PLT) ≥ 90 × 109/L; hemoglobin (Hb) ≥ 90 g/L;
   2. 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;
   3. coagulation: international normalized ratio (INR) or prothrombin time (PT) ≤ 1.5 × ULN; activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
   4. Heart: left ventricular ejection fraction (LVEF) ≥ 50% as assessed by echocardiography (ECHO) or multigated acquisition (MUGA).
   5. 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.
   6. Urinalysis: urine protein < 2 +, if urine protein ≥ 2 +, 24-hour urine protein quantification must show protein ≤ 1 g.

9. Voluntarily participate in this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.

Exclusion Criteria

1. Tumor involving skin, ulceration, inflammatory breast cancer patients
2. Fatty breast cancer.
3. Tumors on the deep surface of areolar region
4. KPS score < 70, or ECOG score > 2
5. Patients with a history of concomitant collagen connective tissue disease, or any active autoimmune disease or autoimmune disease.
6. Prior radiotherapy or prior use of investigational drugs or other immunosuppressive agents
7. Heart, brain, lung, kidney and other vital organ failure, liver and kidney dysfunction;
8. Uncorrectable severe coagulopathy
9. Patient is pregnant or lactating
10. Poor glycemic control in diabetes
11. Patients with foreign body implantation around the tumor
12. Patients with severe scars on the skin of the treatment area (protruding from the skin surface, width ≥ 1 cm)
13. History of chronic immunosuppression, prior immunotherapy, recent vaccination (< 4 weeks)
14. 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).
15. 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Microwave Ablation alone	Microwave Ablation	Microwave Ablation+ Breast Surgery
Microwave Ablation alone	Breast Surgery	Microwave Ablation+ Breast Surgery
Camrelizumab alone	Breast Surgery	Camrelizumab+ Breast Surgery
Microwave Ablation & Camrelizumab	Microwave Ablation	Microwave Ablation + Camrelizumab + Breast Surgery
Microwave Ablation & Camrelizumab	Breast Surgery	Microwave Ablation + Camrelizumab + Breast Surgery
Camrelizumab alone	Camrelizumab	Camrelizumab+ Breast Surgery
Microwave Ablation & Camrelizumab	Camrelizumab	Microwave Ablation + Camrelizumab + Breast Surgery

Primary Outcome Measures

Name	Time	Method
Safety of Microwave Ablation Combined With Camrelizumab	3 months	Safety measured by occurrence of study related adverse effects defined by NCI CTCAE 5.0

Secondary Outcome Measures

Name	Time	Method
Breast self evaluation	3 months	Breast self evaluation for patients will be assessed by Functional Assessment of Cancer Therapy - Breast (FACT-B) scale scores.The FACT-B consists of 44 self-report items and assesses the specific breast cancer-related quality of life on 4 general and 1 breast-cancer specific subscale. A higher score indicates a higher cancer-related quality of life.
Complete ablation rate	1 day	The proportion of patients with complete ablation was calculated for all patients. Complete ablation was defined as: tissue section at the ablation margin that was negative by histochemical staining.
Negative predictive value of ultrasound	1 day	Preoperative ultrasonography was performed. The negative predictive value of ultrasound was calculated by comparing the pathology report. Negative predictive value = number of patients with negative pathology and negative ultrasound/number of patients with negative ultrasound
Assessment of Immunogenicity	3 months	Proportion of subjects with immune response to synergistic therapy detected by biomarkers in peripheral blood samples

Trial Locations

Locations (1)

the First Affiliated Hospital of Nanjing Medical University; 🇨🇳 Nanjing, Jiangsu, China