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

NCT ID: NCT05301881

Last Updated: 2025-02-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 118 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-17
• Study Completion Date: 2040-04-01

Brief Summary

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

Breast Cancer Invasive; Metastatic Cancer; Oligoprogressive

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Surgery, radiotherapy or radiofrequent ablation

The oligoprogresive lesion(s) will be treated with Surgery, radiotherapy or radiofrequent ablation depending on the location of the lesion. treatment will be standard of care and will be decided by the treating team of the patient.

Group Type: OTHER

Surgery

Intervention Type: PROCEDURE

resection of the oligometastatic lesion(s)

Radiotherapy

Intervention Type: RADIATION

radiation of the oligometastatic lesion(s)

Radiofrequent ablation

Intervention Type: OTHER

radiofrequent ablation of the oligometastatic lesion(s)

Interventions

Surgery

resection of the oligometastatic lesion(s)

Intervention Type: PROCEDURE

Radiotherapy

radiation of the oligometastatic lesion(s)

Intervention Type: RADIATION

Radiofrequent ablation

radiofrequent ablation of the oligometastatic lesion(s)

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Maarten van de Weijden Foundation

UNKNOWN

Sponsor Role: collaborator

The Netherlands Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

G Sonke

Role: PRINCIPAL_INVESTIGATOR

The Netherlands Cancer Institute

Locations

Noordwest Ziekenhuisgroep

Alkmaar, , Netherlands

Site Status: NOT_YET_RECRUITING

Antoni van Leeuwenhoek

Amsterdam, , Netherlands

Site Status: RECRUITING

Rijnstate

Arnhem, , Netherlands

Site Status: RECRUITING

Deventer ziekenhuis

Deventer, , Netherlands

Site Status: NOT_YET_RECRUITING

ADRZ

Goes, , Netherlands

Site Status: RECRUITING

Martini ziekenhuis

Groningen, , Netherlands

Site Status: NOT_YET_RECRUITING

Antonius ziekenhuis

Utrecht, , Netherlands

Site Status: NOT_YET_RECRUITING

Countries

Netherlands

Central Contacts

G Sonke, MD

Role: CONTACT

g.sonke@nki.nl

+31-20-512 ext. 9111

A Almekinders

Role: CONTACT

c.almekinders@nki.nl

Facility Contacts

S Vrijaldenhoven, MD

Role: primary

G Sonke, MD

Role: primary

g.sonke@nki.nl

A Almekinders, MD

Role: backup

c.almekinders@nki.nl

K J Beelen, MD

Role: primary

info@rijnstate.nl

+31880058888

A Imholz, MD

Role: primary

E van Vliet, MD

Role: primary

researchbureau@adrz.nl

+31881250000

A van der Velden, MD

Role: primary

M Agterof, MD

Role: primary

Other Identifiers

M21CSM

Identifier Type: -

Identifier Source: org_study_id