Breast Cancer Invasive, Metastatic Cancer, Oligoprogressive
Conditions
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 percutaneous ablation.
Interventions
PROCEDURESurgery
resection of the oligometastatic lesion(s)
RADIATIONRadiotherapy
radiation of the oligometastatic lesion(s)
OTHERRadiofrequent ablation
radiofrequent ablation of the oligometastatic lesion(s)
Sponsors
The Netherlands Cancer Institute
Maarten van de Weijden Foundation
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically confirmed invasive breast cancer * Metastatic breast cancer * o Oligoprogression is defined as an increase of ≥20% in size or, in case of FDG-PET-CT, metabolic activity (≥20% in SUVmax) involving a maximum of two lesions. These lesions may consist of: 1 or 2 distant metastatic lesions limited to 1 organ, the primary tumor or locoregional lymph nodes. * 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. * Lesion(s) must be amenable to resection, radiotherapy or percutaneous ablation with the intent of local obliteration. * The radiological imaging that shows progression must be performed within 70 days 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 * Lymph nodes should be larger than 15 mm upon first detection of oligoprogression to be classified as progressive. * Oligo-progression has to be confirmed with a FDG-PET-CT-scan 5-7 weeks after the initial scan that showed oligoprogression. * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients free of progression at 6 months | At 6 months | progression-free survival at 6 months (PFS-6) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of patients free of progression at 6 months per histoligical subtype | At 6 months | PFS-6 for breast cancer subtypes: ER+/HER2- vs. HER2+ vs. TN |
| Number of patients free of progression at 6 months per breast cancer subtype | At 6 months | PFS-6, stratified by breast cancer subtype \- localization of progressive lesion |
| Number of patients free of progression at 6 months per localization of progressive lesion | At 6 months | PFS at 6 months separately for localization of progressive lesion: locoregional vs. cranial vs. visceral vs. bone |
| Overall Surival (OS) | Up to 120 months | Evaluation of overall survival measured from baseline till death due to any cause |
| Time to next line of treatment | Up to 120 months | Time to next line of systemic therapy meeasured from baseline |
| Number of patients who develop "visceral crisis" | Up to 120 months | number of patients who develop "visceral crisis" |
| Number of patients who develop complications after local ablative treatment | Up to 120 months | Assess the number of patients who develop complications after local ablative treatment |
Countries
Netherlands
Contacts
CONTACTG Sonke, MD
CONTACTRobin van den Borg, MD
PRINCIPAL_INVESTIGATORG Sonke
The Netherlands Cancer Institute
Outcome results
None listed