Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer

Not Applicable

• Conditions: Breast Neoplasms; Neoplasm Recurrence, Local
• Interventions: Radiation: Accelerated Partial Breast Irradiation

• Registration Number: NCT03583580
• Lead Sponsor: Chinese Academy of Medical Sciences

Brief Summary

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.

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 Timeline

• Study Start: 2017-06-19
• Study First Submitted: 2018-06-19
• Study First Submitted QC: 2018-06-28
• Study First Posted: 2018-07-11
• Primary Completion: 2021-12-30
• Status Verified: 2022-01
• Last Update Submitted: 2022-01-06
• Last Update Posted: 2022-01-11
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 537

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: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Accelerated Partial Breast Irradiation	Accelerated Partial Breast Irradiation	Accelerated partial breast irradiation (APBI) to the region of tumour bed

Primary Outcome Measures

Name	Time	Method
locoregional control rate	5 years	ipsilateral breast and axilla nodal relapse rate

Secondary Outcome Measures

Name	Time	Method
distant-metastasis survival	5 years	distant metastasis
overall survival	5 years	any death
disease-free survival	5 years	any recurrence or death

Trial Locations

Locations (1)

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