Status:
COMPLETED
Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients
Lead Sponsor:
Fudan University
Conditions:
Breast Cancer
Eligibility:
FEMALE
50-85 years
Phase:
NA
Brief Summary
The study was designed to evaluate the feasibility and safety of hypofractionated partial breast irradiation after breast-conserving surgery for low-risk breast cancer patients.
Detailed Description
A total dose of 40.05Gy in 15 fractions was delivered to the tumor bed for each eligible breast cancer patients. The endpoints including loco-regional recurrence, cosmetic outcomes, and toxicities, we...
Eligibility Criteria
Inclusion
- Female
- Age≥ 50 years
- Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
- Negative surgical margins
- Pathologically confirmed invasive breast cancer
- A pathological T1N0M0 tumor -IHC: ER+/PR+/HER2-
- Tumor bed is labeled with Titanium clips
- Received adjuvant hormonal treatment
- No adjuvant chemotherapy
- ECOG:0-1
- Written informed consent.
Exclusion
- Age\<50 years
- KPS\<70
- Treated with neoadjuvant chemotherapy
- Treated or being treated with chemotherapy
- With severe comorbidity
- Previous breast cancer or other malignant tumor history
- Previous radiotherapy for breast or thorax
- Medical contraindication for radiotherapy
- Pregnant or nursing
Key Trial Info
Start Date :
April 1 2015
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 15 2019
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT03411174
Start Date
April 1 2015
End Date
July 15 2019
Last Update
May 13 2025
Active Locations (1)
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1
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200032