Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Maarten van de Weijden Foundation | UNKNOWN |
Not provided
Not provided
Not provided
Patients with oligoprogression of metastatic breast cancer during palliative treatment that is amenable to local therapy will be included. The local ablative therapy (LAT) may consist of stereotactic ablative radiotherapy (SABR), also known as stereotactic body radiation therapy, surgery or radiofrequency ablation (RFA).
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery, radiotherapy or radiofrequent ablation | Other | The oligoprogresive lesion(s) will be treated with Surgery, radiotherapy or radiofrequent ablation depending on the location of the lesion. treatment will be standard of care and will be decided by the treating team of the patient. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | resection of the oligometastatic lesion(s) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients free of progression at 6 months | progression-free survival at 6 months (PFS-6) | At 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients free of progression at 6 months per histoligical subtype | PFS-6 for breast cancer subtypes: ER+/HER2- vs. HER2+ vs. TN | At 6 months |
| Number of patients free of progression at 6 months per breast cancer subtype |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| G Sonke, MD | Contact | +31-20-512 | 9111 | g.sonke@nki.nl |
| A Almekinders | Contact | c.almekinders@nki.nl |
| Name | Affiliation | Role |
|---|---|---|
| G Sonke | The Netherlands Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Noordwest Ziekenhuisgroep | Not yet recruiting | Alkmaar | Netherlands |
to be determined
Not provided
Not provided
Not provided
Not provided
Not provided
Lesion(s) will be treated with surgery, radiotherapy or radiofrequent ablation depending on the location. The treatment is standard of care and will be decided in the treating team of the patient.
Not provided
Not provided
Not provided
Not provided
| Radiotherapy | Radiation | radiation of the oligometastatic lesion(s) |
|
| Radiofrequent ablation | Other | radiofrequent ablation of the oligometastatic lesion(s) |
|
PFS-6, stratified by breast cancer subtype
- localization of progressive lesion
| At 6 months |
| Number of patients free of progression at 6 months per localization of progressive lesion | PFS at 6 months separately for localization of progressive lesion: locoregional vs. cranial vs. visceral vs. bone | At 6 months |
| Overall Surival (OS) | Evaluation of overall survival measured from baseline till death due to any cause | Up to 120 months |
| Time to next line of treatment | Time to next line of systemic therapy meeasured from baseline | Up to 120 months |
| Number of patients who develop "visceral crisis" | number of patients who develop "visceral crisis" | Up to 120 months |
| Number of patients who develop complications after local ablative treatment | Assess the number of patients who develop complications after local ablative treatment | Up to 120 months |
| Antoni van Leeuwenhoek | Recruiting | Amsterdam | Netherlands |
|
| Rijnstate | Recruiting | Arnhem | Netherlands |
|
| Deventer ziekenhuis | Not yet recruiting | Deventer | Netherlands |
|
| ADRZ | Recruiting | Goes | Netherlands |
|
| Martini ziekenhuis | Not yet recruiting | Groningen | Netherlands |
|
| Antonius ziekenhuis | Not yet recruiting | Utrecht | Netherlands |
|
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| ID | Term |
|---|---|
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
| D011878 | Radiotherapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
Not provided
Not provided