Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer

Chinese Academy of Medical Sciences & Peking Union Medical College

Status

Active, not recruiting

Conditions

Breast Neoplasms

Neoplasm Recurrence, Local

Treatments

Radiation: Accelerated Partial Breast Irradiation

Study type

Interventional

Funder types

Other

Identifiers

NCT03583580

NCC201804006

Details and patient eligibility

About

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.

Full 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.

Enrollment

537 estimated patients

Sex

Female

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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.