Hypofractionated PBI After BCS for Low-risk Breast Cancer Patients

Fudan University

Status: Completed

Conditions: Breast Cancer

Treatments: Radiation: hypofractionated partial breast irradiation

Study type: Interventional

Funder types: Other

Identifiers

NCT03411174

FDRT-BC003

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: Female

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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 criteria

• 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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220 participants in 1 patient group

HF-PBI

Experimental group

Description:

Hypofractionated partial breast irradiation was delivered to the tumor bed areas for low recurrence risk breast cancer patients, with prescription dose 40Gy in 15 fractions in 3 weeks.

Treatment:

Radiation: hypofractionated partial breast irradiation