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Brain radiation for breast cancer: prevention study halted early

NCT ID NCT01613482

Prevention Sponsor: Centre Oscar Lambret 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
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 18, 2026 · Updated 2 times

Summary

This study looked at whether giving radiation to the brain could prevent cancer from spreading there in people with HER2-positive breast cancer that had already spread to other organs. Participants were receiving trastuzumab (Herceptin) plus chemotherapy. The study was stopped early because not enough people enrolled, so we don't have clear answers.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

13 people

The number who actually took part.

Started

Jan 2008

Finished

Jan 2012

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 70 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: * Patients with breast cancer, expressing HER2-NEU (score +++ in ICH or ++ and amplification on FISH or CISH, SISH) * Visceral metastasis, only or multiple * First line metastasis treatment by Trastuzumab in association with chemotherapy * Good general conditions: OMS=\<2 or Karnofsky \>=70% * Age \> 18 years and \< 70 years * Life expectancy \>=3 mois * No Trastuzumab since more of 6 months * No cerebral metastasis (MRI) * Efficacy contraception for women with genital capacities * Consent signed by the patient Exclusion Criteria * Contraindication to IRM * Psychiatric decease * Prior cerebral radiotherapy, * Geographical constraint, compromising the fallow of patients * Infectious or other serious pathology, likely to stop the treatment * Positive serology (HIV, hBC, hBS) * Inclusion in an other clinical trial or in the 4 weeks before th inclusion * Pregnant or breastfeeding women

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma breast neoplasm HER2 positive breast carcinoma metastatic neoplasm Neoplasm Metastasis metastatic malignant neoplasm in the brain prevention target

As listed by the trial registrant

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

Breast cancer Metastasis Sur-expressing HER2-neu

Contacts and locations

Locations

  • CHU Dupuytren

    Limoges, 87042, France

  • Centre Alexis Vautrin

    Vandœuvre-lès-Nancy, 54511, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Azuréen de Cancérologie

    Mougins, 06250, France

  • Centre Bourgogne

    Lille, 59000, France

  • Centre Catalan d'Oncologie

    Perpignan, 66000, France

  • Centre Catherine de Sienne

    Nantes, 44202, France

  • Centre Etienne DOLET

    Saint-Nazaire, 44600, France

  • Centre G-François Baclesse

    Caen, 14076, France

  • Centre Hospitalier

    Boulogne-sur-Mer, 62200, France

  • Centre Hospitalier LYON SUD

    Pierre-Bénite, 69495, France

  • Centre Hospitalier de Mulhouse

    Mulhouse, 68100, France

  • Centre Léonard de Vinci

    Dechy, 59187, France

  • Centre Maurice Tubiana

    Caen, 14052, France

  • Centre Médical de Forcilles

    Forcilles-attilly, 77150, France

  • Centre Oscar LAMBRET

    Lille, 59020, France

  • Centre Paul Papin

    Angers, 49933, France

  • Centre René Huguenin

    Saint-Cloud, 92210, France

  • Centre de Cancérologie Paris Nord

    Sarcelles, 95200, France

  • Centre médical Oncogard

    Nîmes, 30907, France

  • Clinique Clinique Clementville

    Montpellier, 34000, France

  • Clinique Hartmann

    Neuilly-sur-Seine, 92200, France

  • Clinique des Ormeaux- Vauban

    Le Havre, 76600, France

  • Hôpital Tenon

    Paris, 75020, France

  • Institut Gustave Roussy

    Villejuif, 94805, France

  • Oncorad Garonne

    Toulouse, 31400, France

More trials for these conditions

Other studies related to the condition(s) this trial covers.