Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer

A Multicenter Phase Ⅱ Prospective Clinical Trial of Accelerated Partial Breast Irradiation With IMRT After Breast-conserving Surgery in Early Breast Cancer

This study is to evaluate the efficacy and toxicity of accelerated partial breast irradiation (ABPI) with intensity modulated radiation therapy (IMRT) in low-risk breast cancer treat with breast-conserving surgery.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Neoplasms; Neoplasm Recurrence, Local
• Intervention / Treatment: Radiation: Accelerated Partial Breast Irradiation

Detailed Description

This study is a national multicenter phase II prospective clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients will receive ABPI to a total dose of 40Gy, in 10 fractions, 4Gy/fx/day, within 2 weeks. Intensity modulated radiation therapy (IMRT) technique is used. During Follow up, the locoregional recurrence,survival,acute and late adverse events,and quality of life will be prospectively evaluated.

• Study Type: Interventional
• Enrollment (Estimated): 537
• 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: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Accelerated Partial Breast Irradiation; Accelerated partial breast irradiation (APBI) to the region of tumour bed	Radiation: Accelerated Partial Breast Irradiation; Patients are irradiated to the region of tumour bed using intensity modulated radiation therapy (IMRT)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
locoregional control rate	ipsilateral breast and axilla nodal relapse rate	5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
overall survival	any death	5 years
disease-free survival	any recurrence or death	5 years
distant-metastasis survival	distant metastasis	5 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
acute and late adverse events assessed by CTCAE v4.0	acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result	5 years
quality of life measured with BR-23 questionnaire	BR-23 questionnaire	2 years
the incidence of second malignancy	pathologically diagnosis of contralateral breast cancer and other malignant tumors after radiotherapy	5 year

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

Study record dates

Study Major Dates

• Study Start (Actual): July 19, 2018
• Primary Completion (Estimated): July 1, 2030
• Study Completion (Estimated): July 1, 2031

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): May 19, 2026
• Last Update Submitted That Met QC Criteria: May 17, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: phase II; intensity-modulated radiation therapy; Breast conserving surgery; Accelerate partial breast irradiation
• 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: NCC201804006

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

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