A phase I/II clinical trial of radical radiotherapy using carbon-ion beams with standard adjuvant therapy for early breast cancer

Phase 1

Recruiting

• Conditions: Breast cancer; D001943

• Registration Number: JPRN-jRCTs032180154
• Lead Sponsor: Karasawa Kumiko

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-02-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 30

Inclusion Criteria

1. Pathologically proven invasive ductal carcinoma or ductal carcinoma in situ.
2. Tumor size <=20 mm on MRI.
3. No massive LVSI or EIC.
4. No lymphenode metastasis (>2 mm). Sentinel lymph node biopsy is performed prior this study.
5. No distant metastasis.
6. Performance status (ECOG) of 0 to 2.
7. 20 years old or older.
8. A life expectancy of at least 6 months.
9. Written informed consent.

Exclusion Criteria

1. Severe complication (e.g. uncontroled lung disease, heart disease, infection, or psychiatric disease).
2. Previous treatment history including surgery, chemotherapy, endocrine therapy, molecular-targeted agents for breast cancer in same side.
3. Active other malignancy
4. The distanse between skin surface and tumor (including EIC) <=5 mm.
5. Previous radiation therapy for breast cancer in same side.
6. Eligible patients for Breast cancer I or Breast cancer III.
7. Pregnancy, pregnancy potential.
8. Ptinents who are considered inappropriate by the attending physician due to medical, psychological or other factors.

Study & Design

• Study Type: Interventional
• Study Design: Not specified