Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer

N/AActive Not RecruitingNCT03583580

Cancer Institute and Hospital, Chinese Academy of Medical Sciences537 enrolled

Overview

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.

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

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

537

Conditions

Breast Neoplasms Neoplasm Recurrence, Local

Interventions

Accelerated Partial Breast IrradiationRADIATION

Patients are irradiated to the region of tumour bed using intensity modulated radiation therapy (IMRT)

Eligibility

Sex: FEMALEMin age: 45 YearsMax age: 75 Years

Medical Language ↔ Plain English

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.

Locations (1)

National Cancer Center/Cancer Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Outcomes

Primary Outcomes

locoregional control rate

ipsilateral breast and axilla nodal relapse rate

Time frame: 5 years

Secondary Outcomes

overall survival

any death

Time frame: 5 years

disease-free survival

any recurrence or death

Time frame: 5 years

distant-metastasis survival

distant metastasis

Time frame: 5 years

Data from ClinicalTrials.gov

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