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

Breast Cancer Clinical Trial

Official title:

A Pilot Study of Single-Dose Camrelizumab and/or Microwave Ablation in Women With Early-Stage Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04805736
• Other study ID #: MA-BC-?-021
• Status: Completed
• Phase: Phase 2
• Start date: March 25, 2021
• Est. completion date: April 30, 2023

Study information

• Verified date: January 2024
• Source: The First Affiliated Hospital with Nanjing Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: April 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Microwave Ablation
Image-guided microwave ablation 7-10 days prior to surgery

Drug:
• Camrelizumab
Camrelizumab 200 mg was given a few days after microwave ablation

Procedure:
• Breast Surgery
Standard of care breast conserving surgery or radical mastectmoy

Locations

Country	Name	City	State
China	the First Affiliated Hospital of Nanjing Medical University	Nanjing	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
The First Affiliated Hospital with Nanjing Medical University	Jiangsu HengRui Medicine Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Complete ablation rate	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.	1 day
Secondary	Negative predictive value of ultrasound	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	1 day
Secondary	Assessment of Immunogenicity	Proportion of subjects with immune response to synergistic therapy detected by biomarkers in peripheral blood samples	3 months
Secondary	Breast self evaluation	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.	3 months