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

NCT05301881 | Recruiting Phase 2

• 1 other identifier: M21CSM
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 7

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

Outcome Measures

Primary Outcomes (1)

• Number of patients free of progression at 6 months

  progression-free survival at 6 months (PFS-6)

  At 6 months

Secondary Outcomes (7)

• Number of patients free of progression at 6 months per histoligical subtype

  At 6 months

• Number of patients free of progression at 6 months per breast cancer subtype

  At 6 months

• Number of patients free of progression at 6 months per localization of progressive lesion

  At 6 months

• Overall Surival (OS)

  Up to 120 months

• Time to next line of treatment

  Up to 120 months

Study Arms (1)

Surgery, radiotherapy or radiofrequent ablation

OTHER

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.

Procedure: Surgery; Radiation: Radiotherapy; Other: Radiofrequent ablation

Interventions

Surgery PROCEDURE

resection of the oligometastatic lesion(s)

Surgery, radiotherapy or radiofrequent ablation

Radiotherapy RADIATION

radiation of the oligometastatic lesion(s)

Surgery, radiotherapy or radiofrequent ablation

Radiofrequent ablation OTHER

radiofrequent ablation of the oligometastatic lesion(s)

Surgery, radiotherapy or radiofrequent ablation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 ≥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

You may not qualify 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 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

Sponsors & Collaborators

• The Netherlands Cancer Institute: lead
• Maarten van de Weijden Foundation: collaborator

Study Sites (7)

Noordwest Ziekenhuisgroep

Alkmaar, Netherlands

NOT YET RECRUITING

Antoni van Leeuwenhoek

Amsterdam, Netherlands

RECRUITING

Rijnstate

Arnhem, Netherlands

RECRUITING

Deventer ziekenhuis

Deventer, Netherlands

NOT YET RECRUITING

ADRZ

Goes, Netherlands

RECRUITING

Martini ziekenhuis

Groningen, Netherlands

NOT YET RECRUITING

Antonius ziekenhuis

Utrecht, Netherlands

NOT YET RECRUITING

MeSH Terms

Conditions

Neoplasm Metastasis

Interventions

Surgical Procedures, Operative; Radiotherapy

Condition Hierarchy (Ancestors)

Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• G Sonke

  The Netherlands Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

G Sonke, MD

CONTACT

+31-20-512; g.sonke@nki.nl

A Almekinders

CONTACT

c.almekinders@nki.nl

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Lesion(s) will be treated with surgery, radiotherapy or radiofrequent ablation depending on the location. The treatment is standard of care and will be decided in the treating team of the patient.

Study Record Dates

• First Submitted: March 21, 2022
• First Posted: March 31, 2022
• Study Start: April 17, 2023
• Primary Completion (Estimated): April 1, 2035
• Study Completion (Estimated): April 1, 2040
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

NL (7)