AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 2Ages 18 Years - anyAllThe Netherlands Cancer Institute
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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 percutaneous ablation.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Histologically confirmed invasive breast cancer * Metastatic breast cancer * o Oligoprogression is defined as an increase of โ‰ฅ20% in size or, in case of FDG-PET-CT, metabolic activity (โ‰ฅ20% in SUVmax) involving a maximum of two lesions. These lesions may consist of: 1 or 2 distant metastatic lesions limited to 1 organ, the primary tumor or locoregional lymph nodes. * 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. * Lesion(s) must be amenable to resection, radiotherapy or percutaneous ablation with the intent of local obliteration. * The radiological imaging that shows progression must be performed within 70 days prior to LAT. * Bone metastases are classified as progressive if the lytic component of the lesion increases by โ‰ฅ20% or the FDG-uptake increases by โ‰ฅ20% on FDG-PET-CT * Lymph nodes should be larger than 15 mm upon first detection of oligoprogression to be classified as progressive. * Oligo-progression has to be confirmed with a FDG-PET-CT-scan 5-7 weeks after the initial scan that showed oligoprogression. * Age โ‰ฅ18 * World Health Organization (WHO) Performance Status 0 or 1 * Signed written informed consent before patient registration according to ICH/GCP, and national/local regulations Exclusion Criteria: * 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: Pertuzumab/trastuzumab+docetaxel followed by pertuzumab/trastuzumab will be viewed as one line of systemic therapy. * Other malignancy except carcinoma in situ and basal-cell and squamous cell carcinoma of the skin, unless the other malignancy was treated โ‰ฅ5 years ago with curative intent without the use of chemotherapy or radiation therapy * 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
๐Ÿ’Š

What it tests

  • Surgery
  • Radiotherapy
  • Radiofrequent ablation
๐Ÿ“

Where

7 sites
Noordwest Ziekenhuisgroep
Alkmaar, Netherlands
Antoni van Leeuwenhoek
Amsterdam, Netherlands
Rijnstate
Arnhem, Netherlands
Deventer ziekenhuis
Deventer, Netherlands
ADRZ
Goes, Netherlands
Martini ziekenhuis
Groningen, Netherlands
Antonius ziekenhuis
Utrecht, Netherlands
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy