Clinical trial NCT05301881: COntinue the SaMe Systemic Therapy After Local Ablative Therapy for Oligo Progression in Metastatic Breast Cancer - the COSMO Study
Official title: COntinue the SaMe Systemic Therapy After Local Ablative Therapy for Oligo Progression in Metastatic Breast Cancer - the COSMO Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Breast Cancer Invasive
Metastatic Cancer
Oligoprogressive
Lead sponsor: The Netherlands Cancer Institute
Sponsor class: OTHER
Collaborators: name: Maarten van de Weijden Foundation
First posted: 2022-03-31
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: 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.
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Number of patients free of progression at 6 months
timeFrame: At 6 months
Secondary outcomes:
measure: Number of patients free of progression at 6 months per histoligical subtype
timeFrame: At 6 months
measure: Number of patients free of progression at 6 months per breast cancer subtype
timeFrame: At 6 months
measure: Number of patients free of progression at 6 months per localization of progressive lesion
timeFrame: At 6 months
measure: Overall Surival (OS)
timeFrame: Up to 120 months
measure: Time to next line of treatment
timeFrame: Up to 120 months
measure: Number of patients who develop "visceral crisis"
timeFrame: Up to 120 months
measure: Number of patients who develop complications after local ablative treatment
timeFrame: Up to 120 months
Other outcomes:
Locations:
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Amsterdam
country: Netherlands
facility: Antoni van Leeuwenhoek
city: Arnhem
country: Netherlands
facility: Rijnstate
city: Deventer
country: Netherlands
facility: Deventer ziekenhuis
city: Goes
country: Netherlands
facility: ADRZ
city: Groningen
country: Netherlands
facility: Martini ziekenhuis
city: Utrecht
country: Netherlands
facility: Antonius ziekenhuis
Study officials:
affiliation: The Netherlands Cancer Institute
name: G Sonke
role: PRINCIPAL_INVESTIGATOR
References: