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Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer

Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer

Non Recruiting
45-75 years
Female
Phase N/A

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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.

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.

Eligibility

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 details
    Breast Neoplasms
    Neoplasm Recurrence
    Local

NCT03583580

Chinese Academy of Medical Sciences

20 August 2025

FAQs

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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