Combining radiotherapy and systemic therapy for newly diagnosed metastatic breast cancer
Official title: Preoperative Radiotherapy and Systemic Therapy Following Surgery in 'de Novo' Metastatic Breast Cancer (Protocol MF22-01; Intervention Systemic Treatment METastasis-ISTMET)
Run by Ankara Oncology Research and Training Hospital · NCT05334459 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years to 80 Years |
| Sex | Women only |
| Enrollment | 40 (estimated) |
| Sponsor | Ankara Oncology Research and Training Hospital Research network |
| Drugs / interventions | radiation, immunotherapy |
| Locations | 1 site (Ankara) |
| Status | Recruiting |
| Started | March 1, 2022 |
| Main results expected | March 1, 2023 |
| Study ends | March 31, 2028 |
| Registry record updated | April 26, 2022 |
| Trial ID | NCT05334459 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a 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.
✕Probably not a fit
Patients with primary tumors that cannot be completely resected or those with poor physical condition may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: Previous studies have shown promising results with similar multimodal approaches in improving overall survival for metastatic breast cancer patients.
Who can join: the full rules
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 it's running
-
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
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
PRT13722 in advanced HR+/HER2- breast cancer
This early study tests PRT13722, by itself and with standard therapies, to see if it is safe and has any signs of activity in adults with HR+/HER2- breast cancer who have progressed on prior treatments.
-
Personalized treatment after endocrine therapy failure in metastatic breast cancer
The study tests whether using a patient’s fresh tumor sample to try different drugs outside the body can help pick the next therapy for hormone receptor-positive, HER2-negative metastatic breast cancer that progressed on endocrine therapy.
-
SSGJ-612 plus a HER2-targeted ADC in HR-positive, HER2-low metastatic breast cancer
This phase II study tests whether adding SSGJ-612 to a HER2-targeted antibody-drug conjugate helps people with HR-positive, HER2-low or ultralow metastatic breast cancer.
-
SMP-656 in HER2-positive advanced breast cancer after ADC therapy
This trial tests whether SMP-656 given by IV every 3 weeks can help people with HER2-positive locally advanced or metastatic breast cancer who progressed after a HER2-targeted antibody-drug conjugate.
-
Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure
This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.
-
T-DXd–based therapy followed by targeted HER2 blockade and endocrine therapy in first-line HER2+ / HR+ metastatic breast cancer
This trial tests a sequence of therapies starting with T-DXd plus pertuzumab, then a maintenance phase with dual HER2 blockade, endocrine therapy, and CDK4/6 inhibitor, with a retreatment option of T-DXd if disease progresses.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.