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.
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
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
Single group
Surgery
Procedure/Surgeryresection of the oligometastatic lesion(s)
Radiotherapy
Radiationradiation of the oligometastatic lesion(s)
Radiofrequent ablation
Other interventionradiofrequent ablation of the oligometastatic lesion(s)
Number of patients free of progression at 6 months
progression-free survival at 6 months (PFS-6)
Number of patients free of progression at 6 months per histoligical subtype
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
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
PFS at 6 months separately for localization of progressive lesion: locoregional vs. cranial vs. visceral vs. bone
Overall Surival (OS)
Evaluation of overall survival measured from baseline till death due to any cause
Click on the lead sponsor to view all of their trials.
The Netherlands Cancer Institute
Lead sponsor
Maarten van de Weijden Foundation
Collaborator
