A pilot study to assess the safety and feasibility of stereotactic ablative body radiosurgery combined with MK-3475 in patients with oligometastases from breast cancer.

Peter MacCallum Cancer Centre0 sites15 target enrollmentNovember 11, 2014

Overview

No summary available.

Registry

who.int

Start Date

November 11, 2014

End Date

TBD

Last Updated

6 years ago

Study Type

Interventional

Sex

All

Sponsor

Peter MacCallum Cancer Centre

•1\. Be willing and able to provide written informed consent/assent for the trial.
•2\. Be 18 years of age on day of signing informed consent.
•3\. Have histologically or cytologically confirmed breast cancer. Oligometastatic lesions do not need to be biopsied but they must be strongly suspected to represent metastatic disease.
•4\. CT scan (Chest, Abdo \+ Pelvis), Whole Body Bone scan, and FDG\-PET scan evidence of 1 to 5 metastases within 8 weeks of study registration.
•Note: At least 1 of the 5 metastases must be deemed suitable for SABR treatment.
•5\. Be willing to provide tissue from a newly obtained core or excisional biopsy of a tumour lesion. Newly\-obtained is defined as a specimen obtained up to 6 weeks (42 days) prior to initiation of treatment on Day 1\. Participants for whom newly\-obtained samples cannot be provided (e.g. inaccessible or participant safety concern) may submit an archived specimen only upon agreement from the study P.I’s.
•6\. Have a performance status of 0\-2 on the ECOG Performance Scale.
•7\. Demonstrate adequate organ function.
•8\. Life expectancy \> 12 months.
•9\. Be willing and able to comply with all study requirements, including treatment, attending assessments and follow\-up.

•1\. Previous high dose radiotherapy (BED \> 20Gy) to an area to be treated which includes vertebral bodies.
•2\. Evidence of brain metastases.
•3\. Intention to treat with any chemotherapy agent within \+/\- 3 weeks of study treatment.
•4\. Evidence of Spinal Cord Compression.
•5\. Spinal Instability Neoplastic Score greater than or equal to 7 unless lesion reviewed by a neurosurgical service and considered stable. A dose of 28Gy in 2 fractions can be considered after review at SABR chart round.
•6\. Surgical fixation of bone lesion required for stability.
•7\. Lytic metastases in a long bone (femur or humerus) that erodes the cortex.
•8\. Is currently participating and receiving study therapy or has participated in a study of an investigational agent and is planned to receive study therapy or used an investigational device within 4 weeks of study treatment.
•9\. Has a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy or any other form of immunosuppressive therapy at time of study registration.
•10\. Has a plan to receive or did receive a prior anti\-cancer monoclonal antibody (mAb) within 4 weeks prior to study treatment or has not recovered from adverse events (i.e. AEs not at \= Grade 1 or at baseline values) due to agents administered more than 4 weeks earlier.