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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05301881
Other study ID # M21CSM
Secondary ID
Status Recruiting
Phase Phase 2
First received
Last updated
Start date April 17, 2023
Est. completion date April 1, 2040

Study information

Verified date July 2023
Source The Netherlands Cancer Institute
Contact G Sonke, MD
Phone +31-20-512
Email g.sonke@nki.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


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Study Design


Intervention

Procedure:
Surgery
resection of the oligometastatic lesion(s)
Radiation:
Radiotherapy
radiation of the oligometastatic lesion(s)
Other:
Radiofrequent ablation
radiofrequent ablation of the oligometastatic lesion(s)

Locations

Country Name City State
Netherlands Noordwest Ziekenhuisgroep Alkmaar
Netherlands Antoni van Leeuwenhoek Amsterdam
Netherlands Deventer ziekenhuis Deventer
Netherlands Martini ziekenhuis Groningen
Netherlands Antonius ziekenhuis Utrecht

Sponsors (2)

Lead Sponsor Collaborator
The Netherlands Cancer Institute Maarten van de Weijden Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of patients free of progression at 6 months progression-free survival at 6 months (PFS-6) At 6 months
Secondary 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
Secondary Number of patients free of progression at 6 months per breast cancer subtype PFS-6, stratified by breast cancer subtype
- localization of progressive lesion
At 6 months
Secondary 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
Secondary Overall Surival (OS) Evaluation of overall survival measured from baseline till death due to any cause Up to 120 months
Secondary Time to next line of treatment Time to next line of systemic therapy meeasured from baseline Up to 120 months
Secondary Number of patients who develop "visceral crisis" number of patients who develop "visceral crisis" Up to 120 months
Secondary 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
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