Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Breast Cancer

Breast Cancer Clinical Trial

— STEREO-SEIN  

Official title:

Multicentric Phase III Trial of Superiority of Stereotactic Body Radiation Therapy in Patients With Metastatic Breast Cancer in First-line Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02089100
• Other study ID #: 2013-A00142-43
• Secondary ID: 2013/1957
• Status: Recruiting
• Phase: Phase 3
• Start date: February 2014
• Est. completion date: February 2023

Study information

• Verified date: July 2018
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: Céline BOURGIER, MD
• Phone: 04 67 61 25 19
• Email: celine.bourgier[@]icm.unicancer.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: February 2023
• Est. primary completion date: February 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

6. The primary tumor has to have been treated with curative intent (surgery and /or radiotherapy) 7. No prior treatment for metastatic relapse

It will be accpeted patients which would have begun a treatment in the case where:

• Hormonotherapy </= 1 month

• Chemotherapy </= 1 cycle 8. a. Metastatic lesions out of previous radiation field 8. b. Equal or less than 5 metastatic lesions (measurable or not) 8. c. In case of measurable lesions, each </=10 cm or </=500 mL 9. 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 10. For abdominal mets:

1. Adequate renal function with a creatinine clearance (Cockroft formula) > 60ml/min

11. Absence of any psychological, familial, sociological or geographical condition with a potential to hamper compliance with the study protocol and follow-up schedule 12. Life expectancy > 3 months 13. Affiliated to Health Insurance regimen 14. Written and signed consent form

Exclusion Criteria:

1. Triple negative breast cancer 3. Prior systemic treatment in metastatic setting (endocrine therapy, chemotherapy, targeted therapies, radionuclide) 4. Brain metastases 5. In spinal cord mets:

1. More than 3 consecutive and contagious 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 instability or neurological deficit resulting from bony compression of neural structures 6. Scleroderma or connective tissue disease as a contraindication to radiotherapy 7. Pregnancy or breast feeding period

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Radiation:
• stereotactic body radiation therapy

• Systemic treatment

Locations

Country	Name	City	State
France	Gustave Roussy Cancer Campus Grand Paris	Villejuif	Val De Marne

Sponsors (1)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	evaluated with a minimal follow-up of 3 years in all patients
Secondary	Cumulative rate of local failure	assessed with RECIST1.1 criteria	evaluated with a minimum follow-up of 3 years in all patients.
Secondary	Overall survival		evaluated with a minimum follow-up of 3 years in all patients