NCT02257775TerminatedNot Applicable
Evolution of Resistance to Systemic Therapies in Patients With Breast Cancer
Institute of Cancer Research, United Kingdom1 site in 1 country5 target enrollmentStarted: May 11, 2015Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 5
- Locations
- 1
- Primary Endpoint
- Progression rate of liver metastases
Study Overview
Brief Summary
The objective of this study is to apply Whole-body DW imaging alongside the routine management of patients requiring systemic therapy for metastatic breast cancer to compare the time to progression of individual liver metastases within and between patients following stable disease or partial response to palliative systemic therapy for breast cancer.
Study Design
- Study Type
- Observational
- Observational Model
- Case Only
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age over 18 years.
- •First metastatic breast cancer relapse after treatment for early stage disease
- •A minimum of 10 evaluable lesions in the liver on routine x-ray CT imaging
- •Patient prescribed cytotoxic, endocrine or biological therapies
- •Patient physically and psychologically fit enough to consider sequential WB-- - DWI imaging alongside their standard disease monitoring
- •Written informed consent
Exclusion Criteria
- •Diagnosis of other cancer within the last 5 years, other than resected non-melanoma skin cancer or cervical intraepithelial neoplasia
- •Diagnosis of brain metastases.
- •Contraindication to magnetic resonance MR imaging
Outcomes
Primary Outcomes
Progression rate of liver metastases
Time Frame: 3 months
Patients will be monitored by routine CT scans after 3 cycles of cytotoxic/biological therapy or after 3 months of endocrine therapy
Secondary Outcomes
- Progression rate of skeletal metastases(3 months)
- Patient acceptability of WB-DWI assessed from questionnaires provided between WB-DWI scans and quantified using a 5-point Likert scale(3 months)
- Global and local lesion Apparent Diffusion Coefficient (ADC) distributions of WB-DWI scans within individual patient(3 months)
- Comparison of patient acceptability to whole-body CT(3 months)
Investigators
Study Sites (1)
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