Combining radiotherapy and systemic therapy for newly diagnosed metastatic breast cancer
Preoperative Radiotherapy and Systemic Therapy Following Surgery in 'de Novo' Metastatic Breast Cancer (Protocol MF22-01; Intervention Systemic Treatment METastasis-ISTMET)
This study is testing whether combining local radiation treatment with other therapies can help people with newly diagnosed metastatic breast cancer live longer, especially those with cancer that has spread only to the bones.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 80 Years |
| Sex | Female |
| Sponsor | Ankara Oncology Research and Training Hospital Research network |
| Drugs / interventions | radiation, immunotherapy |
| Locations | 1 site (Ankara) |
| Trial ID | NCT05334459 on ClinicalTrials.gov |
What this trial studies
This observational study focuses on patients with de novo metastatic breast cancer (dnMBC) who are candidates for locoregional treatment (LRT) followed by systemic therapy. It aims to evaluate the impact of a multimodal approach on overall survival, particularly for patients with bone-only metastases. The study involves a multidisciplinary tumor board to assess treatment decisions based on patient-related factors and tumor biology. By analyzing outcomes from patients who undergo LRT, the study seeks to provide insights into the potential benefits of this combined treatment strategy.
Who should consider this trial
Good fit: Ideal candidates include patients with a primary breast tumor that can be completely surgically resected and who are in good physical condition for treatment.
Not a fit: Patients with primary tumors that cannot be completely resected or those with poor physical condition may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could improve overall survival rates for patients with de novo metastatic breast cancer.
How similar studies have performed: Previous studies have shown promising results with similar multimodal approaches in improving overall survival for metastatic breast cancer patients.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Primary breast tumor amenable for complete surgical resection, patients in good physical condition for receiving protocol driven locoregional and systemic treatments and receiving radiotherapy. Exclusion Criteria: * Primary tumor not amenable for complete resection; primary tumor with extended infection, bleeding, or necrosis; patients with poor physical condition which prevents the patient from receiving protocol driven locoregional and systemic treatment; synchronous primary cancer at the contralateral breast; clinically involved contralateral axillary nodes; patients not suitable for adequate follow-up, and failure to give informed consent. Pregnancy and lactation.
Where this trial is running
Ankara
- Lutfi Dogan — Ankara, Turkey (Türkiye) (Recruiting)
Study contacts
- Principal investigator: Serdar Ozbas, Prof — Endocrine and Breast Surgeon-Ankara
- Study coordinator: Lutfi Dogan, Prof
- Email: lutfidogan1@yahoo.com
- Phone: +905057134549
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.