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

Metastatic Cancer Clinical Trial

— COSMO  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05301881
• Other study ID #: M21CSM
• Status: Recruiting
• Phase: Phase 2
• Start date: April 17, 2023
• Est. completion date: April 1, 2040

Study information

• Verified date: July 2023
• Source: The Netherlands Cancer Institute
• Contact: G Sonke, MD
• Phone: +31-20-512
• Email: g.sonke[@]nki.nl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 118
• Est. completion date: April 1, 2040
• Est. primary completion date: April 1, 2035
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Histologically confirmed invasive breast cancer

• MBC according to TNM-staging

• 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

• Oligoprogression should occur during first- or second-line systemic therapy

• 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 49 (+/- 3) days prior to registration.

• 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 6 weeks (42 days) after the first screening scan.

• 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

Related Conditions & MeSH terms

• Breast Cancer Invasive
• Breast Neoplasms
• Metastatic Cancer
• Oligoprogressive

Intervention

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)

Locations

Country	Name	City	State
Netherlands	Noordwest Ziekenhuisgroep	Alkmaar
Netherlands	Antoni van Leeuwenhoek	Amsterdam
Netherlands	Deventer ziekenhuis	Deventer
Netherlands	Martini ziekenhuis	Groningen
Netherlands	Antonius ziekenhuis	Utrecht

Sponsors (2)

Lead Sponsor	Collaborator
The Netherlands Cancer Institute	Maarten van de Weijden Foundation

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients free of progression at 6 months	progression-free survival at 6 months (PFS-6)	At 6 months
Secondary	Number of patients free of progression at 6 months per histoligical subtype	PFS-6 for breast cancer subtypes: ER+/HER2- vs. HER2+ vs. TN	At 6 months
Secondary	Number of patients free of progression at 6 months per breast cancer subtype	PFS-6, stratified by breast cancer subtype; - localization of progressive lesion	At 6 months
Secondary	Number of patients free of progression at 6 months per localization of progressive lesion	PFS at 6 months separately for localization of progressive lesion: locoregional vs. cranial vs. visceral vs. bone	At 6 months
Secondary	Overall Surival (OS)	Evaluation of overall survival measured from baseline till death due to any cause	Up to 120 months
Secondary	Time to next line of treatment	Time to next line of systemic therapy meeasured from baseline	Up to 120 months
Secondary	Number of patients who develop "visceral crisis"	number of patients who develop "visceral crisis"	Up to 120 months
Secondary	Number of patients who develop complications after local ablative treatment	Assess the number of patients who develop complications after local ablative treatment	Up to 120 months