Actively Recruiting
Continue the Same Systemic Therapy After Local Ablative Therapy for Oligoprogression in Metastatic Breast Cancer - the COSMO Study
Led by The Netherlands Cancer Institute · Updated on 2025-02-05
118
Participants Needed
7
Research Sites
261 weeks
Total Duration
On this page
Sponsors
T
The Netherlands Cancer Institute
Lead Sponsor
M
Maarten van de Weijden Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying patients with metastatic breast cancer who experience oligoprogression during palliative treatment that can be treated locally. This phase 2 study focuses on evaluating local ablative therapies such as surgery, stereotactic ablative radiotherapy (SABR), and radiofrequency ablation (RFA) to treat progressing lesions while continuing systemic therapy. The aim is to understand how these local treatments affect disease progression and patient outcomes. The local ablative therapy will target one or two progressing metastatic lesions, which may be located in one organ, the primary tumor, or locoregional lymph nodes. Treatment options include surgery, radiotherapy, or radiofrequency ablation, chosen based on the lesion's location and standard care decisions by the treating medical team. Systemic therapy with endocrine, targeted, chemotherapy, or immune-checkpoint blockade will be ongoing for at least six months before and during this local treatment. Participants will be monitored for disease progression, with the primary outcome measuring the number of patients free from progression at 6 months. Evaluations include imaging scans, such as FDG-PET-CT, to confirm oligoprogression and assess treatment response. Secondary outcomes include progression by breast cancer subtype, overall survival up to 120 months, time to next treatment, and complications after local ablative therapy. The study involves informed consent, regular follow-ups, and safety monitoring throughout the trial period.
CONDITIONS
Brief Title
COntinue the SaMe Systemic Therapy After Local Ablative Therapy for Oligo Progression in Metastatic Breast Cancer - the COSMO Study
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed invasive breast cancer
- Metastatic breast cancer
- Oligoprogression defined as one or two distant metastatic lesions limited to one organ or locoregional sites, increasing 620% in size and larger than 15 mm or increased metabolic activity on FDG-PET-CT
- On systemic therapy (endocrine, targeted, chemotherapy, or immune-checkpoint blockade) for at least six months with stable disease or better
- Oligoprogression confirmed by imaging within 70 days prior to local ablative therapy and confirmed again 5-7 weeks later by FDG-PET-CT
- Lesions amenable to surgery, radiotherapy, or radiofrequency ablation
- Age 18 years or older
- WHO Performance Status 0 or 1
- Signed informed consent according to regulations
You will not qualify if you...
- More than two lines of systemic therapy for metastatic breast cancer received
- Other malignancy except certain skin cancers or carcinoma in situ unless treated over 5 years ago without chemotherapy or radiation
- Current pregnancy or breastfeeding; women of childbearing potential must use contraception
- Any medical condition placing patient at unusual risk as judged by clinician
- Any psychological, familial, sociological, or geographical condition that may impair compliance with study protocol and follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Duration varies depending on treatment
Participants receive local ablative therapy including surgery, radiotherapy, or radiofrequent ablation of the oligometastatic lesion(s) as determined by the treating team.
1 to 3 visits depending on treatment type
Duration - Ongoing as per standard of care
Participants continue their systemic therapy for metastatic breast cancer after local ablative treatment.
Visit schedule according to routine clinical care
Duration - Up to 120 months
Participants are monitored for disease progression, survival, and complications after local ablative treatment and during continued systemic therapy.
Regular follow-up visits as per study schedule
Trial Site Locations
Total: 7 locations
1
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Not Yet Recruiting
2
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Actively Recruiting
3
Rijnstate
Arnhem, Netherlands
Actively Recruiting
4
Deventer ziekenhuis
Deventer, Netherlands
Not Yet Recruiting
5
ADRZ
Goes, Netherlands
Actively Recruiting
6
Martini ziekenhuis
Groningen, Netherlands
Not Yet Recruiting
7
Antonius ziekenhuis
Utrecht, Netherlands
Not Yet Recruiting
Research Team
G
G Sonke, MD
A
A Almekinders
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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