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New treatment option for Breast Cancer Invasive
Official title COntinue the SaMe Systemic Therapy After Local Ablative Therapy for Oligo Progression in Metastatic Breast Cancer - the COSMO Study
ClinicalTrials.gov ID: NCT05301881
What this study is testing
- What it's testing
- 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).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- 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.
You likely can't join if
- Having received more than two lines of systemic therapy for MBC If a treatment regimen has been de-escalated without adding other therapies, this is...
- Other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated ≥5 years...
- Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection
- Presence of any medical condition that would place the patient at unusual risk, up to the discretion of the clinician
- Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and...
See the full eligibility criteria
- 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...
- 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
- Having received more than two lines of systemic therapy for MBC If a treatment regimen has been de-escalated without adding other therapies, this is seen as one line of therapy. For example...
- Other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated ≥5 years ago with curative intent without the use of chemotherapy or radiation...
- Current pregnancy or breastfeeding. Women of childbearing potential must use adequate contraceptive protection
- Presence of any medical condition that would place the patient at unusual risk, up to the discretion of the clinician
- Presence of any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
The study team makes the final eligibility decision.
Where it's taking place
- Alkmaar, Netherlands
- Amsterdam, Netherlands
- Arnhem, Netherlands
- Deventer, Netherlands
- Goes, Netherlands
- Groningen, Netherlands
- Utrecht, Netherlands
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Alkmaar, Netherlands; Amsterdam, Netherlands; Arnhem, Netherlands; Deventer, Netherlands; Goes, Netherlands; Groningen, Netherlands and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.