Microwave Ablation in the Treatment of Early-stage Unifocal Invasive Breast Cancer

Last updated: February 25, 2024
Sponsor: The First Affiliated Hospital with Nanjing Medical University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Treatment

Microwave Ablation

Clinical Study ID

NCT06288620
MA-EBC-II-024
  • Ages 18-70
  • Female

Study Summary

Microwave Ablative (MWA) therapy, as a minimally invasive thermal therapy, has been attempted to treat breast cancer of small lesions . However, the optimal indications for MWA in the treatment of breast cancer is unknown. This prospective, open-label, single-arm phase II clinical study was conducted to evaluate the efficacy and safety of MWA in the treatment of early-stage unifocal invasive breast cancer, and to explore the immune activating effect.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. female patients aged 18-70 years;
  2. patients with newly diagnosed invasive breast cancer confirmed by core needle biopsy;
  3. the tumor smaller than 2cm in greatest diameter confirmed by US (ultrasonography),breast X-ray and breast MRI (contrast-enhanced magnetic resonance image ) wereperformed at the same time, and the difference of the largest diameter between breastUS and MRI was less than 0.5 cm;
  4. the single tumor without other suspicious lesions (BI-RADS (the Breast ImagingRecording and Data System) score ≥4) evaluated by breast US, X-ray and MRI;
  5. the tumor without adhesion to chest wall, nipple or skin;
  6. patients without distant metastasis;
  7. Karnofsky performance status greater than 70%.

Exclusion

Exclusion Criteria:

  1. multicentric or multifocal breast tumor;
  2. the tumor located on nipple and areola area;
  3. signs of extensive intraductal carcinoma on imaging examination (diffuse malignantcalcification on breast X-ray or segmental distribution, non-mass enhancement, ductalor linear enhancement > 2.5 cm on MRI);
  4. extensive intraductal component in invasive cancer (more than 50% of the tumor volume)confirmed by pathology;
  5. invasive lobular carcinoma, metaplastic carcinoma or carcinoma with sclerosingadenosis;
  6. patients who were pregnant or breastfeeding;
  7. patients with evidence of coagulopathy, chronic liver diseases or renal failure;
  8. patients with previous treatment including chemotherapy, targeted drug therapy, orlocal radiation therapy, etc;
  9. patients with substance abuse, or mental or psychological disorders that may interferewith study compliance;
  10. any condition that is unstable or likely to compromise the patient's safety andcompliance;
  11. patients enrolled in other clinical trials;
  12. diseases or symptoms that other investigators consider unsuitable for participation.

Study Design

Total Participants: 77
Treatment Group(s): 1
Primary Treatment: Microwave Ablation
Phase:
Study Start date:
February 25, 2024
Estimated Completion Date:
May 30, 2025

Connect with a study center

  • the First Affiliated Hospital of Nanjing Medical University

    Nanjing, Jiangsu
    China

    Active - Recruiting

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