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Breast CancerPhase 3NCT01413269

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

A Phase 3 study testing radiotherapy in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 4 sites in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
radiotherapy
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
720 participants
Where
4 sitesChina
Study dates
Jun 2010to Sep 2018
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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

Who cannot join

  • 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
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  • active collagen vascular disease
  • prior neoadjuvant hormone therapy
  • immediate ipsilateral breast reconstruction

Trial locations and contacts

4 sites in 1 country.

China4 sites

  • Beijing hospital

    Beijing, Beijing Municipality, 100730

  • Cancer Hospital, Chinese Academy of Medical Sciences

    Beijing, 100021

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Zhongshan Hospital Fudan University

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: Phase 3 Open-labeled Randomized Clinical Study of Comparing Hypofractionated and Conventional Radiotherapy for Breast Cancer Patients 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.

Conditions
Breast Cancer
Being tested
radiotherapy
Keywords
breast cancer patients, breast conservation surgery, hypofractionated radiotherapy
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • radiotherapyRadiation

    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.

Study groups in NCT01413269
Study groupRoleWhat they receive
hypofractionation radiotherapyExperimentalirradiation 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.
Receives: Radiation: radiotherapy
conventional fractionation radiotherapyActive comparatorirradiation 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.
Receives: Radiation: radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. in-breast recurrence rate

    evidence of ipsilateral breast local recurrence confirmed by histology

    Measured: 5 year

Secondary outcomes (5)

  1. regional node recurrence rate

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

    Measured: 5 year

  2. disease-free survival

    locoregional relapse, distant relapse, death

    Measured: 5 year

  3. overall survival

    any death

    Measured: 5 year

  4. acute toxicity

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

    Measured: 6 months

  5. late complication

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

    Measured: 3 -10 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2011 (estimated)
  2. Study startJun 2010
  3. Primary completionSep 2015
  4. Study completionSep 2018

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
720 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01413269
Sponsor's protocol ID
CH-BC-013
Status last verified
Oct 2018
First submitted
9 Aug 2011
Last updated
12 Jan 2026
Results posted
No
Data monitoring committee
Yes

Publications

  • Wang SL, Fang H, Hu C, Song YW, Wang WH, Jin J, Liu YP, Ren H, Liu J, Li GF, Du XH, Tang Y, Jing H, Ma YC, Huang Z, Chen B, Tang Y, Li N, Lu NN, Qi SN, Yang Y, Sun GY, Liu XF, Li YX. Hypofractionated Versus Conventional Fractionated Radiotherapy After Breast-Conserving Surgery in the Modern Treatment Era: A Multicenter, Randomized Controlled Trial From China. J Clin Oncol. 2020 Nov 1;38(31):3604-3614. doi: 10.1200/JCO.20.01024. Epub 2020 Aug 11.

    PubMed 32780661

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing radiotherapy in people with Breast Cancer, run by Cancer Institute and Hospital, Chinese Academy of Medical Sciences at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

in-breast recurrence rate (time frame: 5 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01413269, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2026.

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