COntinue the SaMe Systemic Therapy After Local Ablative Therapy for Oligo Progression in Metastatic Breast Cancer - the COSMO Study

Status: Recruiting
Location: See all (7) locations...
Intervention Type: Procedure, Other, Radiation
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically confirmed invasive breast cancer

• Metastatic breast cancer

• Oligoprogression defined as one or two distant metastatic lesions, limited to one organ, or the primary tumor or locoregional lymph nodes, increasing ≥20% in size and be larger than 15 mm or if metabolic activity increases (with 20% in SUVmax) on FDG-PET-CT.

• Systemic treatment can be either endocrine, targeted, chemotherapy or immune-checkpoint blockade

• Patients should be on systemic therapy for at least six months. Status should be stable disease or partial or complete response for at least 6 months.

• Oligoprogression has to be detected with radiological imaging comparing the lesion on the same type of imaging modality as has been used at the start of systemic therapy.

• The radiological imaging that shows progression must be performed within 70days prior to LAT.

• Bone metastases are classified as progressive if the lytic component of the lesion increases by ≥20% or the FDG-uptake increases by ≥20% on FDG-PET-CT

• Oligo-progression has to be confirmed with a FDG-PET-CT-scan 5-7 weeks after the initial scan that showed oligoprogression.

• Lesion(s) must be amenable to resection, radiotherapy or radiofrequency ablation with the intent of local obliteration

• Age ≥18

• World Health Organization (WHO) Performance Status 0 or 1

• Signed written informed consent before patient registration according to ICH/GCP, and national/local regulations

Locations
Other Locations
Netherlands
Noordwest Ziekenhuisgroep
NOT_YET_RECRUITING
Alkmaar
Antoni van Leeuwenhoek
RECRUITING
Amsterdam
Rijnstate
RECRUITING
Arnhem
Deventer ziekenhuis
NOT_YET_RECRUITING
Deventer
ADRZ
RECRUITING
Goes
Martini ziekenhuis
NOT_YET_RECRUITING
Groningen
Antonius ziekenhuis
NOT_YET_RECRUITING
Utrecht
Contact Information
Primary
G Sonke, MD
g.sonke@nki.nl
+31-20-512
Backup
A Almekinders
c.almekinders@nki.nl
Time Frame
Start Date: 2023-04-17
Estimated Completion Date: 2040-04-01
Participants
Target number of participants: 118
Treatments
Other: Surgery, radiotherapy or radiofrequent ablation
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.
Related Therapeutic Areas
Sponsors
Collaborators: Maarten van de Weijden Foundation
Leads: The Netherlands Cancer Institute

This content was sourced from clinicaltrials.gov

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