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

Phase 3

Recruiting

• Conditions: Breast Cancer
• Interventions: Radiation: stereotactic body radiation therapy; Radiation: Systemic treatment

• Registration Number: NCT02089100
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Study First Submitted: 2014-03-13
• Study First Submitted QC: 2014-03-14
• Study First Posted: 2014-03-17
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-13
• Last Update Posted: 2024-08-15
• Primary Completion: 2025-06
• Study Completion: 2026-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 280

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 prior treatment for metastatic relapse. It will be accepted patients which would have begun a treatment in the case where:

   1. Hormonotherapy </= 1 month
   2. Chemotherapy </= 1 cycle

   The treatment must be stopped after signature of the consent form.

7. 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 instability or 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
stereotactic body radiation therapy	Systemic treatment	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.
stereotactic body radiation therapy	stereotactic body radiation therapy	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.
no specific treatment	Systemic treatment	no specific treatment to the oligometastatic sites except for palliation (pain, compression, hemorrhage)

Primary Outcome Measures

Name	Time	Method
Progression Free Survival (PFS)	evaluated with a minimal follow-up of 3 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.

Secondary Outcome Measures

Name	Time	Method
Cumulative rate of local failure	evaluated with a minimum follow-up of 3 years in all patients.	assessed with RECIST1.1 criteria
Overall survival	evaluated with a minimum follow-up of 3 years in all patients

Trial Locations

Locations (1)

Gustave Roussy Cancer Campus Grand Paris; 🇫🇷 Villejuif, Val De Marne, France