Breast CancerPhase 3STEREO-SEINNCT02089100
Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer
A Phase 3 study testing stereotactic body radiation therapy and Systemic treatment in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 18 sites in France.
Trial summary
The previous reported phase I study allows us to prospectively define the optimal total dose in different metastatic locations (88). However, several questions are still unanswered such as the adequate timing of the stereotactic body radiation therapy (SBRT) in oligometastatic disease. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- stereotactic body radiation therapy and Systemic treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- 18 sitesFrance
- Study dates
- 26 Feb 2014to Oct 2034
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy proven breast cancer stage IV AJCC TNM
- Age >18 years
- WHO status≤2
- Hormonal receptors positive breast cancer (IHC)
- The primary tumor was treated or will be treated with curative intent (surgery and/or radiotherapy)"
- No new treatment for metastatic relapse Prior history of adjuvant hormonotherapy or relapse under adjuvant hormonotherapy are not exclusion criteria.
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- It will be accepted patients which would have begun new line of systemic treatment in the case where:
- Hormonotherapy or CDK4/6 inhibitors ≤ 3 months.
- 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.
- 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:
- adequate liver function (liver enzyme <3N, bilirubin<30mg/dl, albumin>2.5g/dl),
- no underlying cirrhosis or hepatitis
- liver metastase size ≤7cm diameter
- not adjacent to stomach or small bowel 9. For abdominal mets:
- 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:
- Triple negative breast cancer
- Prior systemic treatment in metastatic setting (endocrine therapy, chemotherapy, targeted therapies, radionuclide)
- Brain metastases
- In spinal cord mets:
- More than 3 consecutive and contiguous spinal segments involved by tumor
- Neurological examination prior randomization >1 week
- Inability to tolerate treatment (unable to lie flat)
- Treated with radionuclide/systemic chemotherapy within 30 days before SBRT
- Significant or progressive neurological deficit
- More than 25% spinal canal compromise
- Malignant epidural spinal cord compression or cauda equina syndrome
- Spine instabilityor neurological deficit resulting from bony compression of neural structures
- Scleroderma or connective tissue disease as a contraindication to radiotherapy
- Pregnancy or breast feeding period
Who cannot join
None listed.
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
France18 sites
Institut Sainte Catherine
Avignon, 84918
Centre François Baclesse
Caen, 14076
Georges François Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Hôpital Nord
Marseille, 13015
Institut Paoli Calmettes
Marseille, 13273
CHU la Timone
Marseille, 13385
ICM - Val d'Aurelle
Montpellier, 34298
Centre Antoine Lacassagne
Nice, 06189
Centre Eugène Marquis
Rennes, 35042
Henri Becquerel
Rouen, 76000
Institut de cancérologie de l'Ouest René Gauducheau
Saint-Herblain, 44805
Institut de Cancérologie de l'Ouest
Saint-Herblain, 44805
Centre de Cancérologie Paris Nord
Sarcelles, 95200
Centre de Radiothérapie de la Robertsau
Strasbourg, 67000
Centre Paul Strauss
Strasbourg, 67065
Hôpital Bretonneau
Tours, 37000
Gustave Roussy Cancer Campus Grand Paris
Villejuif, Val de Marne, 94805
About this study
Official title: Multicentric Phase III Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Metastatic Breast Cancer in First-line Treatment
The previous reported phase I study allows us to prospectively define the optimal total dose in different metastatic locations (88). However, several questions are still unanswered such as the adequate timing of the stereotactic body radiation therapy (SBRT) in oligometastatic disease. Indeed, there are two different oligometastatic states: "de novo", i.e. occurring at first metastatic presentation without any previous systemic therapy; and "secondary", defined as residual disease after systemic treatment.
The investigators wish to prospectively study the role of metastases SBRT with curative intent in de novo oligometastatic disease.
This clinical trial would be the first randomized study studying SBRT at onset of the metastatic disease. If this trial shows a PFS improvement, it will definitively change the standard of treatment and it will highlight SBRT as a key treatment of metastatic disease. It will confirm the oligometastasis hypothesis as well as the Simon Norton hypothesis (92).
- Conditions
- Breast Cancer
- Being tested
- stereotactic body radiation therapy, Systemic treatment
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
stereotactic body radiation therapyRadiation
Systemic treatmentRadiation
| Study group | Role | What they receive |
|---|---|---|
| stereotactic body radiation therapy | Experimental | The SBRT of all metastases should start in maximum 4 weeks after randomization. Beginning of systemic treatment will take place before 2 and 7 days after SBRT completion. All metastases lesions should be treated every 48h. Receives: Radiation: stereotactic body radiation therapy; Radiation: Systemic treatment |
| no specific treatment | Active comparator | no specific treatment to the oligometastatic sites except for palliation (pain, compression, hemorrhage) Receives: Radiation: Systemic treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression Free Survival (PFS)
events: local recurrence, distant progression of the target metastases, any new metastasis, death of any cause The definition of progression is based on RECIST1.1 criteria. Progression is assessed locally, in any metastasis present at the time of randomization or in any newly diagnosed metastasis.
Measured: evaluated with a minimal follow-up of 5 years in all patients
Secondary outcomes (2)
Cumulative rate of local failure
assessed with RECIST1.1 criteria
Measured: evaluated with a minimum follow-up of 5 years in all patients.
Overall survival
Measured: evaluated with a minimum follow-up of 5 years in all patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2014 (estimated)
- Study start26 Feb 2014
- Primary completionOct 2033 (estimated)
- Study completionOct 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Gustave Roussy, Cancer Campus, Grand ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 154 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guillaume LOUVEL, MD, Principal investigator, Gustave Roussy, Cancer Campus, Grand Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02089100
- Sponsor's protocol ID
- 2013-A00142-43
- Other IDs
- 2013/1957
- Acronym
- STEREO-SEIN
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2014
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentric Phase III Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Metastatic Breast Cancer in First-line Treatment
- ClinicalTrials.gov ID
- NCT02089100
- Acronym / sponsor ID
- STEREO-SEIN / 2013-A00142-43
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 154 participants (actual)
- Lead sponsor
- Gustave Roussy, Cancer Campus, Grand ParisUniversity, hospital or other
- Study start
- 26 Feb 2014 (actual)
- Primary completion
- Oct 2033 (estimated)
- Study completion
- Oct 2034 (estimated)
- First posted
- 17 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The previous reported phase I study allows us to prospectively define the optimal total dose in different metastatic locations (88). However, several questions are still unanswered such as the adequate timing of the stereotactic body radiation therapy (SBRT) in oligometastatic disease. Indeed, there are two different oligometastatic states: "de novo", i.e. occurring at first metastatic presentation without any previous systemic therapy; and "secondary", defined as residual disease after systemic treatment.
The investigators wish to prospectively study the role of metastases SBRT with curative intent in de novo oligometastatic disease.
This clinical trial would be the first randomized study studying SBRT at onset of the metastatic disease. If this trial shows a PFS improvement, it will definitively change the standard of treatment and it will highlight SBRT as a key treatment of metastatic disease. It will confirm the oligometastasis hypothesis as well as the Simon Norton hypothesis (92).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| stereotactic body radiation therapy | Experimental | Radiation: stereotactic body radiation therapy, Radiation: Systemic treatmentThe SBRT of all metastases should start in maximum 4 weeks after randomization. Beginning of systemic treatment will take place before 2 and 7 days after SBRT completion. All metastases lesions should be treated every 48h. |
| no specific treatment | Active comparator | Radiation: Systemic treatmentno specific treatment to the oligometastatic sites except for palliation (pain, compression, hemorrhage) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Biopsy proven breast cancer stage IV AJCC TNM
- Age >18 years
- WHO status≤2
- Hormonal receptors positive breast cancer (IHC)
- The primary tumor was treated or will be treated with curative intent (surgery and/or radiotherapy)"
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| stereotactic body radiation therapy | Radiation | stereotactic body radiation therapy |
| Systemic treatment | Radiation | no specific treatment, stereotactic body radiation therapy |
Primary outcome
Progression Free Survival (PFS)
Time frame: evaluated with a minimal follow-up of 5 years in all patients
events: local recurrence, distant progression of the target metastases, any new metastasis, death of any cause The definition of progression is based on RECIST1.1 criteria. Progression is assessed locally, in any metastasis present at the time of randomization or in any newly diagnosed metastasis.
2 secondary outcomes
Cumulative rate of local failure
Time frame: evaluated with a minimum follow-up of 5 years in all patients.
Overall survival
Time frame: evaluated with a minimum follow-up of 5 years in all patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Guillaume LOUVEL, MD principal investigator
Gustave Roussy, Cancer Campus, Grand Paris
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing stereotactic body radiation therapy and Systemic treatment in people with Breast Cancer, run by Gustave Roussy, Cancer Campus, Grand Paris at 18 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 30 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression Free Survival (PFS) (time frame: evaluated with a minimal follow-up of 5 years in all patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.