Can fewer, stronger radiation doses match standard treatment after mastectomy?
NCT ID NCT03856372
First seen Sep 03, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This phase III trial compares two radiation schedules for women with high-risk breast cancer who have had a mastectomy. One group receives hypofractionated radiation, which uses fewer but larger daily doses over a shorter period. The other receives conventional radiation, with smaller doses over a longer period. Researchers want to see if the shorter schedule is just as effective at preventing cancer from returning in the chest or nearby lymph nodes, and whether it causes similar side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Radiation therapy, comparing a shorter course of higher-dose fractions (hypofractionated) with a longer course of standard-dose fractions (conventional)
- What this could lead to
- If shorter radiation courses work as well as standard ones, women with high-risk breast cancer could spend less time in treatment with similar cancer control and fewer side effects.
- What could go wrong
- The trial is large but still experimental. Shorter radiation might not control cancer as well or could cause different side effects, and results are not yet available.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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1,494 people
The number who actually took part.
- Started
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Sep 2018
- Finished
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Aug 2022
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Female * Age18-75 years * Pathologically confirmed invasive breast cancer * Treated with mastectomy and axillary lymph node dissection with more than 10 resected lymph nodes. Immediate or delayed ipsilateral breast cancer reconstruction is accepted * Negative surgical margins * Pathologic T1-2N1 with at least one of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression, or pT3-4, or pN2-3 (four or more positive axillary lymph nodes) * No distant metastases * No supraclavicular or internal mammary nodes metastases * ECOG:0-1 * Adjuvant systemic therapy with chemotherapy, endocrine therapy and anti-HER2 treatment is accepted. * No neoadjuvant chemotherapy * Fit for postoperative radiotherapy. No contraindications to radiotherapy * Signed informed consent Exclusion Criteria: * Concurrent or previous malignancy excluding basal or squamous cell carcinoma of the skin * Previous radiotherapy to the chest wall or regional lymph node areas * Patients with severe non-malignant comorbidity in cardiovascular or respiration system * Patients with medical contraindication for radiotherapy: systemic lupus erythematosus, cirrhosis * pT1-2N1 with none of the following risk factors: \<40 years, Grade 3, lymphovascular invasion positive, ER/PR negative or HER2 overexpression * Patients with supraclavicular or internal mammary nodes metastases * Known definitive clinical or radiologic evidence of metastatic disease * Bilateral breast cancer or historically confirmed contralateral invasive breast cancer * Treated with neoadjuvant chemotherapy * ECOG: 3-4 * Pregnant or lactating * Conditions indicating that the patient cannot go through the radiation therapy or follow up * Unable or unwilling to sign informed consent
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032, China
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Huangpu Branch, Shanghai ninth people's hospital
Shanghai, Shanghai Municipality, China
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Suzhou Municipal hospital
Suzhou, Jiangsu, China
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