Hypofractionated Partial Breast Irradiation After Breast-conserving Surgery for Low-risk Breast Cancer Patients

Fudan University1 site in 1 country220 target enrollmentApril 2015

ConditionsBreast Cancer

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Breast Cancer
Sponsor: Fudan University
Enrollment: 220
Locations: 1
Primary Endpoint: The change of breast cosmetic outcome
Status: Completed
Last Updated: 11 months ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials Related News

Overview

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, were evaluated after treatment.

Registry

clinicaltrials.gov

Start Date

April 2015

End Date

July 15, 2019

Last Updated

11 months ago

Study Type

Interventional

Study Design

Single Group

Sex

Female

Investigators

Sponsor

Fudan University

Responsible Party

Principal Investigator

Jinli Ma

Associate Professor of department of radiation oncology

Fudan University

Eligibility Criteria

Inclusion Criteria

•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
•Written informed consent.

Exclusion Criteria

•Age\<50 years
•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

Outcomes

Primary Outcomes

The change of breast cosmetic outcome

Time Frame: Baseline, and three years after the completion of radiation therapy

The breast cosmetic outcome was measured by Harvard 4 scale (poor, moderate, good, excellent) evaluation system

Secondary Outcomes

Disease free survival(5 years)
Ipsilateral breast tumor recurrence rate(5 years)
Late complications(3 years)
Acute radiation-induced toxicity assessed by CTCAE v4.0(3weeks, 5weeks,1 and 3 months after treatment beginning)
Local-regional recurrence(5 years)
Overall survival(5 years)