Could targeted radiation delay cancer spread in breast cancer patients?
NCT ID NCT02089100
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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154 people
The number who actually took part.
- Started
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Feb 2014
- Expected to finish
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Oct 2034
An estimate. End dates often move.
- 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 years and older
- 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: 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
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CHU la Timone
Marseille, 13385, France
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Centre Antoine Lacassagne
Nice, 06189, France
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Centre Eugène Marquis
Rennes, 35042, France
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Centre François Baclesse
Caen, 14076, France
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Centre Oscar Lambret
Lille, 59020, France
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Centre Paul Strauss
Strasbourg, 67065, France
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Centre de Cancérologie Paris Nord
Sarcelles, 95200, France
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Centre de Radiothérapie de la Robertsau
Strasbourg, 67000, France
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Georges François Leclerc
Dijon, 21079, France
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Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805, France
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Henri Becquerel
Rouen, 76000, France
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Hôpital Bretonneau
Tours, 37000, France
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Hôpital Nord
Marseille, 13015, France
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ICM - Val d'Aurelle
Montpellier, 34298, France
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Institut Paoli Calmettes
Marseille, 13273, France
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Institut Sainte Catherine
Avignon, 84918, France
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Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805, France
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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.
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