Randomized Trial of Accelerated Partial Breast Irradiation

Not Applicable

Completed

• Conditions: Breast Neoplasms; Neoplasm Recurrence, Local
• Interventions: Radiation: WBI; Radiation: APBI

• Registration Number: NCT03583619
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2017-07-19
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-07-11
• Status Verified: 2018-12
• Primary Completion: 2019-01-11
• Study Completion: 2020-03-23
• Last Update Submitted: 2020-03-23
• Last Update Posted: 2020-03-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Number o participants with Grade 2 or more toxicity	5 years	The evaluated toxicities include the following and are evaluated by CTCAE 3.0 criteria: acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result

Secondary Outcome Measures

Name	Time	Method
locoregional recurrence	5 years	ipsilateral breast and axillary nodal recurrence
disease-free survival	5 years	any recurrence or death
Quality of life measured with BR-23 questionnaire	2 years	BR-23 questionnaire
distant-metastasis survival	5 years	distant metastasis
overall survival	5 years	any death

Trial Locations

Locations (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences; 🇨🇳 Beijing, Beijing, China