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Extra radiation boost may cut recurrence risk in early breast cancer

NCT ID NCT00907868

Disease control Sponsor: Institut du Cancer de Montpellier - Val d'Aurelle Source: ClinicalTrials.gov ↗

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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at women with a very early form of breast cancer called ductal carcinoma in situ (DCIS). After surgery to remove the cancer, all women get radiation to the whole breast. Half also get an extra, stronger dose of radiation right where the cancer was. The goal is to see if the extra dose lowers the chance of the cancer coming back. Over 2,000 women took part in this phase III trial.

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
What this could lead to
If successful, this could show that a radiation boost lowers the chance of breast cancer coming back after surgery for early-stage DCIS.
What could go wrong
This is a large, late-stage trial, but the benefit of a boost may be small and could increase side effects. Results may not apply to all patients.

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

2,004 people

The number who actually took part.

Started

Nov 2008

Expected to finish

Oct 2029

An estimate. End dates often move.

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 120 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.

DISEASE CHARACTERISTICS: * Histologically confirmed ductal carcinoma in situ of the breast * No invasive component * No clinically palpable lymph node or presence of tumor cells in the sentinel lymph node (if done) * No local recurrence of a primary breast cancer * No multicentric or multifocal tumors not suitable for conservative surgery R0 with a margin ≥ 1 mm * Has undergone bilateral mammography within 6 months before randomization PATIENT CHARACTERISTICS: * ECOG performance status 0-2 * Life expectancy \> 5 years * Not pregnant * Available for long-term follow up * No history of in situ carcinoma in the contralateral breast * No history of another cancer except for basal cell carcinoma of the skin or carcinoma in situ of the cervix * No uncontrolled cardiac, renal, or pulmonary disease * No uncontrolled systemic disease (e.g., lupus erythematosus or scleroderma) * No HIV positivity * Affiliated with the social health system * No psychological, familial, sociological, or geographical situations that preclude compliance with study treatment and follow up PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No concurrent participation in another therapeutic trial (participation in epidemiologic studies is allowed)

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm ductal breast carcinoma in situ

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle

    Montpellier, 34298, France

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