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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Surgery
  • Radiotherapy
  • Radiofrequent ablation

Treatment groups

118 Participants
are divided into 1 treatment group

Sponsors and collaborators

The Netherlands Cancer Institute

Lead sponsor

Maarten van de Weijden Foundation

Collaborator