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Recruiting NCT05301881

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

Phase II Interventional Breast Cancer Invasive Metastatic Cancer Oligoprogressive

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Surgery, Radiotherapy, Radiofrequent ablation.
Who it may be relevant to
Registry conditions: Breast Cancer Invasive, Metastatic Cancer, Oligoprogressive. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Netherlands
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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).

Interventions

  • Procedure Surgery
    resection of the oligometastatic lesion(s)
  • Radiation Radiotherapy
    radiation of the oligometastatic lesion(s)
  • Other Radiofrequent ablation
    radiofrequent ablation of the oligometastatic lesion(s)

Primary outcome measures

  • Number of patients free of progression at 6 months [Time frame: At 6 months]
Secondary outcome measures (7)
  • Number of patients free of progression at 6 months per histoligical subtype [Time frame: At 6 months]
  • Number of patients free of progression at 6 months per breast cancer subtype [Time frame: At 6 months]
  • Number of patients free of progression at 6 months per localization of progressive lesion [Time frame: At 6 months]
  • Overall Surival (OS) [Time frame: Up to 120 months]
  • Time to next line of treatment [Time frame: Up to 120 months]
  • Number of patients who develop "visceral crisis" [Time frame: Up to 120 months]
  • Number of patients who develop complications after local ablative treatment [Time frame: Up to 120 months]

Eligibility criteria

Inclusion 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 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

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 ≥5 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

Netherlands · 7 centers
  • Noordwest Ziekenhuisgroep — Alkmaar
  • Antoni van Leeuwenhoek — Amsterdam
  • Rijnstate — Arnhem
  • Deventer ziekenhuis — Deventer
  • ADRZ — Goes
  • Martini ziekenhuis — Groningen
  • Antonius ziekenhuis — Utrecht

Identifiers

NCT: NCT05301881 · M21CSM

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗