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NCT Number: NCT03583580

Accelerated Partial Breast Irradiation With IMRT in Early Breast Cancer

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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 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.

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

Accelerated Partial Breast Irradiation

Radiation

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

Primary outcomes

  1. locoregional control rate

    Time frame: 5 years

    ipsilateral breast and axilla nodal relapse rate

Secondary outcomes

  1. overall survival

    Time frame: 5 years

    any death

  2. disease-free survival

    Time frame: 5 years

    any recurrence or death

  3. distant-metastasis survival

    Time frame: 5 years

    distant metastasis

Other outcomes

  1. acute and late adverse events assessed by CTCAE v4.0

    Time frame: 5 years

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

  2. quality of life measured with BR-23 questionnaire

    Time frame: 2 years

    BR-23 questionnaire

  3. the incidence of second malignancy

    Time frame: 5 year

    pathologically diagnosis of contralateral breast cancer and other malignant tumors after radiotherapy

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

A Multicenter Phase Ⅱ Prospective Clinical Trial of Accelerated Partial Breast Irradiation With IMRT After Breast-conserving Surgery in Early Breast Cancer

Important dates

Study start
2018
Primary completion
2030
Study completion
2031
First posted
Jul 11, 2018
Registry last updated
May 19, 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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