Randomized Trial of Accelerated Partial Breast Irradiation

Chinese Academy of Medical Sciences & Peking Union Medical College

Status: Completed

Conditions: Breast Neoplasms; Neoplasm Recurrence, Local

Treatments: Radiation: APBI; Radiation: WBI

Study type: Interventional

Funder types: Other

Identifiers

NCT03583619

NCC-000498

Details and patient eligibility

About

This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.

Full description

This study is a single-center phase II randomized clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients are randomized to receive either ABPI (40Gy/10fx/2wks) or WBI(43.5Gy/15fx/3wks). Intensity modulated radiation therapy (IMRT) technique is used. Grade 2 or more acute and late toxicities are prospectively evaluated and compared.

Enrollment: 140 patients

Sex: Female

Ages: 45 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Life Expectation: > 5 years
• Enrollment date no more than 12 weeks after breast-conserving surgery or no more than 8 weeks after adjuvant chemotherapy
• Histologically confirmed diagnosis of invasive ductal carcinoma (grade 1-2), or mucinous carcinoma, or papillary carcinoma, or tubular carcinoma, or medullary carcinoma: primary tumor ≤ 3.0cm in maximum diameter and pN0; or histologically confirmed DCIS: primary tumor ≤ 2.5cm in maximum diameter, low-medium grade
• Unifocal tumour (confirmed by diagnostic MRI)
• No lymphovascular invasion
• ER positive (defined as medium-strongly nuclear staining in >1% of the cancer cells)
• Negative radial resection margins of >= 2 mm
• Surgical clips placed in the tumor bed
• Written informed consent.

Exclusion criteria

• Stage Ⅱ-Ⅲ
• Multifocal tumors
• Histologically confirmed diagnosis of invasive ductal carcinoma (grade 3), - - - invasive micropapillary carcinoma, carcinoma of lobular in situ, invasive - - - lobular carcinoma
• Paget's disease of the nipple
• Underwent oncoplastic surgery of ipsilateral breast
• Underwent neoadjuvant chemotherapy or hormonal therapy
• Previous or simultaneous contralateral breast cancer
• Undergone ipsilateral chest wall radiotherapy
• Active collagen vascular disease.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

APBI

Experimental group

Description:

Patients receive accelerated partial breast irradiation to tumour bed to a total dose of 40Gy, 4.0Gy per fraction, 5 fractions a week, within 2 weeks.

Treatment:

Radiation: APBI

WBI

Active Comparator group

Description:

Patients receive whole breast irradiation to a total dose of 43.5Gy, at 2.9Gy per fraction, 5 fractions a week, within 3 weeks.

Treatment:

Radiation: WBI