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NCT Number: NCT01413269

Randomized Study of Hypofractionated and Conventional Fractionation Radiotherapy After Breast Conservative Surgery

Early-stage breast cancer patients treated with breast conservative surgery are enrolled in this study if they meet defined criteria. Patients are randomized into two groups: conventional fractionation radiotherapy and hypofractionated radiotherapy.The hypothesis is that conventional fractionation radiotherapy and hypofractionated radiotherapy have similar efficacy and toxicity.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Beijing hospital, Beijing, Beijing Municipality, China

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • KPS>=60
  • histology confirmed invasive breast cancer
  • received breast conservative surgery(wide local excision and axilla dissection, or axillary sentinel node biopsy if sentinel node is negative)
  • surgical margins negative
  • primary tumor ≤5cm in the largest diameter
  • no internal mammary node or supraclavicular node metastases or distant metastasis
  • can tolerate chemotherapy,hormone therapy (if needed) and radiotherapy
  • for patients not need chemotherapy，enrollment date is required no more than 8 weeks from surgery date
  • for patients with chemotherapy first,enrollment date is required no more than 8 weeks from the last date of chemotherapy
  • patients signed written inform consent form

Exclusion criteria

  • ductal carcinoma in situ
  • prior neoadjuvant chemotherapy
  • prior breast cancer history
  • bilateral breast cancer
  • pregnant or during lactation
  • prior or concomitant malignant tumor excluded skin cancer(not malignant melanoma) and cervix carcinoma in situ
  • active collagen vascular disease
  • prior neoadjuvant hormone therapy
  • immediate ipsilateral breast reconstruction

Treatment and study plan

Radiotherapy

Radiation

one group receives radiation to the whole breast to a total dose of 43.5Gy,at 2.9Gy per fraction, 5 fractions a week, followed by tumor bed boost of 8.7Gy, at 2.9Gy per fraction 5 fractions a week.

the other group receives radiation to the whole breast to a total dose of 50Gy,at 2.0Gy per fraction, 5 fractions a week, followed by tumor bed boost of 10Gy, at 2.0Gy per fraction 5 fractions a week.

Primary outcomes

  1. in-breast recurrence rate

    Time frame: 5 year

    evidence of ipsilateral breast local recurrence confirmed by histology

Secondary outcomes

  1. regional node recurrence rate

    Time frame: 5 year

    ipsilateral axillary node, internal mammary node and supraclavicular node recurrence confirmed by physical examination, image evaluation or histology.

  2. disease-free survival

    Time frame: 5 year

    locoregional relapse, distant relapse, death

  3. overall survival

    Time frame: 5 year

    any death

  4. acute toxicity

    Time frame: 6 months

    radiation dermatitis and radiation pneumonitis evaluated and graded by CTC3.0 criteria

  5. late complication

    Time frame: 3 -10 year

    breast cosmetic effect, ischemic heart disease, rib fracture, arm edema and shoulder joint dysfunction

Sponsors and collaborators

Lead sponsor

Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Other

Registry information

Official study title

Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients After Breast Conservative Surgery

Important dates

Study start
2010
Primary completion
2015
Study completion
2018
First posted
Aug 10, 2011
Registry last updated
Jan 12, 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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