Using targeted radiation therapy for breast cancer with metastases

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

This study is testing if a special type of targeted radiation therapy can help people with newly diagnosed breast cancer that has spread to a few other places in the body live longer and feel better compared to standard treatments.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 280 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: Gustave Roussy, Cancer Campus, Grand Paris (other)
• Drugs / interventions: Chemotherapy, radiation
• Locations: 1 site (Villejuif, Val De Marne)
• Trial ID: NCT02089100 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of stereotactic body radiation therapy (SBRT) in patients with de novo oligometastatic breast cancer. It aims to determine the optimal timing and dosage of SBRT when administered at the onset of metastatic disease, compared to standard treatments. The study will evaluate progression-free survival (PFS) to assess whether SBRT can improve outcomes for patients with limited metastatic spread. This is the first randomized trial to explore this approach, potentially redefining treatment standards for metastatic breast cancer.

Who should consider this trial

Good fit: Ideal candidates include adults over 18 with biopsy-proven stage IV breast cancer and limited metastatic lesions.

Not a fit: Patients with extensive metastatic disease or those who have received prior treatment for metastatic relapse may not benefit from this study.

Why it matters

Potential benefit: If successful, this trial could establish SBRT as a key treatment option for patients with oligometastatic breast cancer, improving their survival rates.

How similar studies have performed: Previous studies have suggested the potential of SBRT in treating oligometastatic disease, but this specific approach is novel and untested in a randomized setting.

Eligibility criteria

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

Where this trial is running

Villejuif, Val De Marne

• Gustave Roussy Cancer Campus Grand Paris — Villejuif, Val De Marne, France (RECRUITING)

Study contacts

• Study coordinator: Céline BOURGIER, MD

Conditions: Breast Cancer