Status:
UNKNOWN
Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study
Lead Sponsor:
East and North Hertfordshire NHS Trust
Conditions:
Metastatic Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
This trial is a feasibility study prior to a planned phase III trial. Currently, assessing response to treatment of metastatic breast cancer in the bone is limited by the technical problems associated...
Detailed Description
Patients are eligible for RESPECT if they have bone-only metastatic breast cancer (MBC), as established by standard CT and bone scintigraphy, and are starting a new line of systemic therapy. This can ...
Eligibility Criteria
Inclusion
- Histological diagnosis of breast cancer
- Single or multiple bone metastases (no extraosseous or non-bony metastatic disease permitted)
- Due to start a new line of either hormone therapy or chemotherapy (use of bisphosphonates / denosumab or targeted agents e.g. trastuzumab in addition to hormone therapy / chemotherapy permitted)
- Aged 18 and over
- Life expectancy of over 6 months
- No current active malignancy other than breast cancer
- Written informed consent must be given according to GCP, and national/local regulations
Exclusion
- Radical treatment to sole site of metastatic disease e.g. Cyberknife to solitary bone metastasis
- Absolute contraindication to MRI studies, CT scans or bone scans
- Pregnancy
- Psychological, familial, sociological or geographical conditions that would hamper compliance with the study protocol; such conditions should be discussed with the patient before registration in the trial before patient registration.
Key Trial Info
Start Date :
April 21 2016
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2018
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03266744
Start Date
April 21 2016
End Date
May 1 2018
Last Update
August 30 2017
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