Randomized Trial of Accelerated Partial Breast Irradiation

A Phase II Randomized Clinical Trial of Accelerated Partial Breast Irradiation Compared With Whole Breast Irradiation With IMRT in Early Breast Cancer

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

Study Overview

• Status: Completed
• Conditions: Breast Neoplasms; Neoplasm Recurrence, Local
• Intervention / Treatment: Radiation: APBI; Radiation: WBI

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 Type: Interventional
• Enrollment (Actual): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Radiation: APBI; Patients receive radiation to the breast tumor bed to a total dose of 40Gy/10fx/2wks, using intensity-modulated radiation therapy technique.
Active Comparator: 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.	Radiation: WBI; Patients receive radiation to the whole breast to a total dose of 43.5Gy/15fx/3wks, using intensity-modulated radiation therapy technique.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number o participants with Grade 2 or more toxicity	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	5 years

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
• Investigators: Principal Investigator: Shulian Wang, M.D., National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

Publications and helpful links

General Publications

• Song YC, Sun GY, Fang H, Tang Y, Song YW, Hu C, Qi SN, Chen B, Jing H, Tang Y, Jin J, Liu YP, Lu NN, Li YX, Wang SL. Quality of Life After Partial or Whole-Breast Irradiation in Breast-Conserving Therapy for Low-Risk Breast Cancer: 1-Year Results of a Phase 2 Randomized Controlled Trial. Front Oncol. 2021 Sep 15;11:738318. doi: 10.3389/fonc.2021.738318. eCollection 2021.

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2017
• Primary Completion (Actual): January 11, 2019
• Study Completion (Actual): March 23, 2020

Study Registration Dates

• First Submitted: June 19, 2018
• First Submitted That Met QC Criteria: June 28, 2018
• First Posted (Actual): July 11, 2018

Study Record Updates

• Last Update Posted (Actual): January 26, 2026
• Last Update Submitted That Met QC Criteria: January 22, 2026
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms by Site; Neoplasms; Neoplastic Processes; Skin Diseases; Breast Diseases; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Breast Neoplasms; Neoplasm Recurrence, Local
• Other Study ID Numbers: NCC-000498

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No