Diagnostic device trial for patients with metastatic breast cancer

Study ID: EA1183

Using FDG-PET/CT to assess response of bone-dominant metastatic breast cancer: FEATURE Study

This phase 2 trial studies how well a medical device called FDG-PET/CT works in assessing the treatment response of patients diagnosed with breast cancer that has spread to the bones or mostly to the bones (bone-dominant metastatic breast cancer). Diagnostic procedures such as FDG-PET/CT may work better in measuring breast cancer activity before and after treatment compared to other standard imaging tests.

Trial participants receive FDG intravenous solution and undergo PET/CT scan over 15 to 30 minutes within 21 days before start of standard treatment, and then again at 12 weeks after start of standard treatment.

The primary objective of this non-randomized phase II study is to evaluate the performance of fludeoxyglucose F-18 (FDG)-PET/CT response criteria as a binary predictor of progression-free survival in patients with bone-dominant MBC treated with systemic therapy.

Trial participants receive FDG intravenous solution and undergo PET/CT scan over 15 to 30 minutes within 21 days before start of standard treatment, and then again at 12 weeks after start of standard treatment.

Inclusion Snapshot

  • Must have been diagnosed with metastatic breast cancer that is hormone-receptor positive and with known HER2 status and whose cancer has spread only or predominantly to the bones
  • Must be able to undergo FDG-PET imaging
  • Must be undergoing a systemic therapy such as endocrine therapy, chemotherapy or an HER2-targeted treatment
  • Other inclusion and exclusion criteria apply

Contact Information

Lankenau Institute for Medical Research trial