Can fewer, stronger radiation doses match standard treatment after mastectomy?

NCT ID NCT03856372

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

1,494 people

The number who actually took part.

Started

Sep 2018

Finished

Aug 2022

Lead sponsor

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

18 to 75 years

Sex

Female participants only

Healthy volunteers

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

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

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032, China

  • Huangpu Branch, Shanghai ninth people's hospital

    Shanghai, Shanghai Municipality, China

  • Suzhou Municipal hospital

    Suzhou, Jiangsu, China

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