Actively Recruiting
COntinue the SaMe Systemic Therapy After Local Ablative Therapy for Oligo Progression in Metastatic Breast Cancer - the COSMO Study
Led by The Netherlands Cancer Institute · Updated on 2025-02-05
118
Participants Needed
7
Research Sites
884 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
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).
CONDITIONS
Official 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
- Diagnosed with 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% or more in size and larger than 15 mm, or showing a 20% or more increase in metabolic activity on FDG-PET-CT
- Receiving systemic treatment such as endocrine, targeted therapy, chemotherapy, or immune-checkpoint blockade
- On systemic therapy for at least six months with stable disease, partial response, or complete response during that time
- Oligoprogression detected on the same imaging type used at the start of systemic therapy
- Imaging showing progression performed within 70 days before local ablative therapy
- Bone metastases classified as progressive if lytic lesion or FDG-uptake increases by 20% or more on FDG-PET-CT
- Oligoprogression confirmed with a FDG-PET-CT scan 5-7 weeks after the initial scan
- Lesions must be suitable for surgery, radiotherapy, or radiofrequency ablation to locally destroy them
- Age 18 years or older
- World Health Organization Performance Status 0 or 1
- Signed written informed consent according to regulations
You will not qualify if you...
- Received more than two lines of systemic therapy for metastatic breast cancer, counting de-escalated regimens as one line
- Other cancers except carcinoma in situ or certain skin cancers unless treated more than 5 years ago without chemotherapy or radiation
- Currently pregnant or breastfeeding; women of childbearing potential must use effective contraception
- Any medical condition posing unusual risk as judged by the clinician
- Any psychological, family, social, or geographic issues that may prevent following the study protocol and follow-up schedule
AI-Screening
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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
CONTACT
A
A Almekinders
CONTACT
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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