Continuing systemic therapy after local treatment for metastatic breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on patients with oligoprogression of metastatic breast cancer who are undergoing palliative treatment. It evaluates the effectiveness of continuing systemic therapy after local ablative therapies such as stereotactic ablative radiotherapy, surgery, or radiofrequency ablation. Patients must have stable disease or a partial/complete response to systemic therapy for at least six months before oligoprogression is detected. The goal is to determine if ongoing systemic treatment can improve outcomes for these patients.

Why it matters

Who can join: the full rules

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

Where it's running

• Noordwest Ziekenhuisgroep
  Alkmaar, Netherlands Recruiting
• Antoni van Leeuwenhoek
  Amsterdam, Netherlands Recruiting
• Rijnstate
  Arnhem, Netherlands Recruiting
• Deventer ziekenhuis
  Deventer, Netherlands Recruiting
• Adrz
  Goes, Netherlands Recruiting
• Martini ziekenhuis
  Groningen, Netherlands Recruiting

Study contacts

• Principal investigator: G Sonke — The Netherlands Cancer Institute
• Study coordinator: G Sonke, MD
• Email: g.sonke@nki.nl
• Phone: +31-20-512

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.