Hypofractionated Whole-breast Irradiation With Simultaneously Integrated Boost For Early-Stage Breast Cancer After Breast-conserving Surgery (HF-WBI-SIB)

Fudan University

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Radiation: hypofractionated whole breast irradiation with simultaneously integrated boost

Study type: Interventional

Funder types: Other

Identifiers

NCT02617043

FDRT-BC001

Details and patient eligibility

About

The study was designed to evaluate the feasibility and safety of hypofractionated whole-breast irradiation with simultaneously integrated boost for early-stage breast cancer after breast conserving surgery in Chinese population.

Enrollment: 200 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Female
• 18-60 years old
• Treated with breast conversing surgery and sentinel lymph node biopsy or axillary lymph node dissection
• Pathologically confirmed invasive breast cancer
• A pathological T1-2N0M0 tumor
• Tumor bed is labeled with Titanium clips
• Negative surgical margins
• Written informed consent.

Exclusion criteria

• KPS<70
• Treated with neoadjuvant chemotherapy
• Sentinel lymph nodes only containing isolated tumour cells (<0.2 mm)
• 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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200 participants in 1 patient group

HF-WBI

Experimental group

Description:

Hypofractionated whole breast irradiation for early breast cancer with prescription dose 40Gy in 15 fractions in 3 weeks. Tumor bed is simultaneously integrated boosted to 48Gy.

Treatment:

Radiation: hypofractionated whole breast irradiation with simultaneously integrated boost