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Completed

NCT Number: NCT03583619

Randomized Trial of Accelerated Partial Breast Irradiation

This study is to compare radiation toxicity of accelerated partial breast irradiation (ABPI) with whole breast irradiation (WBI) in low-risk breast cancer.

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Key information

Conditions

Breast Neoplasms Breast Diseases Neoplasm Recurrence, Local Neoplasms Neoplasms by Site Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin and Connective Tissue Diseases

Age range

45 year–75 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Beijing, Beijing Municipality, 100021, China

About this study

This study is a single-center phase II randomized clinical trial to enroll low-risk breast cancer treat with breast-conserving surgery. All eligible patients are randomized to receive either ABPI (40Gy/10fx/2wks) or WBI(43.5Gy/15fx/3wks). Intensity modulated radiation therapy (IMRT) technique is used. Grade 2 or more acute and late toxicities are prospectively evaluated and compared.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

APBI

Radiation

Patients receive radiation to the breast tumor bed to a total dose of 40Gy/10fx/2wks, using intensity-modulated radiation therapy technique.

WBI

Radiation

Patients receive radiation to the whole breast to a total dose of 43.5Gy/15fx/3wks, using intensity-modulated radiation therapy technique.

Primary outcomes

  1. Number o participants with Grade 2 or more toxicity

    Time frame: 5 years

    The evaluated toxicities include the following and are evaluated by CTCAE 3.0 criteria:

    acute skin toxicity,breast swelling, breast pain,radiation pneumonitis, cardiac toxicity, pulmonary fibrosis, cosmetic result

Secondary outcomes

  1. locoregional recurrence

    Time frame: 5 years

    ipsilateral breast and axillary nodal recurrence

  2. overall survival

    Time frame: 5 years

    any death

  3. disease-free survival

    Time frame: 5 years

    any recurrence or death

  4. distant-metastasis survival

    Time frame: 5 years

    distant metastasis

  5. Quality of life measured with BR-23 questionnaire

    Time frame: 2 years

    BR-23 questionnaire

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

A Phase II Randomized Clinical Trial of Accelerated Partial Breast Irradiation Compared With Whole Breast Irradiation With IMRT in Early Breast Cancer

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Jul 11, 2018
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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