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Could targeted radiation delay cancer spread in breast cancer patients?

NCT ID NCT02089100

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a highly focused type of radiation called stereotactic body radiation therapy (SBRT) can delay cancer progression in women with metastatic breast cancer who are starting their first treatment. About 154 participants will receive either standard therapy alone or standard therapy plus SBRT to their tumors. The goal is to see if adding SBRT helps keep the cancer from growing or spreading longer.

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

154 people

The number who actually took part.

Started

Feb 2014

Expected to finish

Oct 2034

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 years and older

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: 1. Biopsy proven breast cancer stage IV AJCC TNM 2. Age \>18 years 3. WHO status≤2 4. Hormonal receptors positive breast cancer (IHC) 5. The primary tumor was treated or will be treated with curative intent (surgery and/or radiotherapy)" 6. No new treatment for metastatic relapse Prior history of adjuvant hormonotherapy or relapse under adjuvant hormonotherapy are not exclusion criteria. It will be accepted patients which would have begun new line of systemic treatment in the case where: 1. Hormonotherapy or CDK4/6 inhibitors ≤ 3 months. 2. Chemotherapy or immunotherapy ≤ 2 cycles. If SBRT arm: The treatment (except hormonotherapy by aromatase inhibitor and/or LHRH agonist) must be interrupted during the completion of radiotherapy. a. Metastatic lesions out of previous radiation field b. Equal or less than 5 metastatic lesions (measurable or not) c. In case of measurable lesions, each ≤10 cm or ≤500 mL 8. For liver mets: 1. adequate liver function (liver enzyme \<3N, bilirubin\<30mg/dl, albumin\>2.5g/dl), 2. no underlying cirrhosis or hepatitis 3. liver metastase size ≤7cm diameter 4. not adjacent to stomach or small bowel 9. For abdominal mets: a. Adequate renal function with a creatinine clearance (Cockroft formula) \> 60ml/min 10. Absence of any psychological, familial, sociological or geographical condition with a potential to hamper compliance with the study protocol and follow-up schedule 11. Life expectancy \> 3 months 12. Affiliated to Health Insurance regimen 13. Written and signed consent form Non-inclusion Criteria: 1. Triple negative breast cancer 2. Prior systemic treatment in metastatic setting (endocrine therapy, chemotherapy, targeted therapies, radionuclide) 3. Brain metastases 4. In spinal cord mets: 1. More than 3 consecutive and contiguous spinal segments involved by tumor 2. Neurological examination prior randomization \>1 week 3. Inability to tolerate treatment (unable to lie flat) 4. Treated with radionuclide/systemic chemotherapy within 30 days before SBRT 5. Significant or progressive neurological deficit 6. More than 25% spinal canal compromise 7. Malignant epidural spinal cord compression or cauda equina syndrome 8. Spine instabilityor neurological deficit resulting from bony compression of neural structures 5. Scleroderma or connective tissue disease as a contraindication to radiotherapy 6. Pregnancy or breast feeding period

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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

  • CHU la Timone

    Marseille, 13385, France

  • Centre Antoine Lacassagne

    Nice, 06189, France

  • Centre Eugène Marquis

    Rennes, 35042, France

  • Centre François Baclesse

    Caen, 14076, France

  • Centre Oscar Lambret

    Lille, 59020, France

  • Centre Paul Strauss

    Strasbourg, 67065, France

  • Centre de Cancérologie Paris Nord

    Sarcelles, 95200, France

  • Centre de Radiothérapie de la Robertsau

    Strasbourg, 67000, France

  • Georges François Leclerc

    Dijon, 21079, France

  • Gustave Roussy Cancer Campus Grand Paris

    Villejuif, Val de Marne, 94805, France

  • Henri Becquerel

    Rouen, 76000, France

  • Hôpital Bretonneau

    Tours, 37000, France

  • Hôpital Nord

    Marseille, 13015, France

  • ICM - Val d'Aurelle

    Montpellier, 34298, France

  • Institut Paoli Calmettes

    Marseille, 13273, France

  • Institut Sainte Catherine

    Avignon, 84918, France

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, 44805, France

  • Institut de cancérologie de l'Ouest René Gauducheau

    Saint-Herblain, 44805, France

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