Status:
TERMINATED
PET/CT Guided Fulvestrant Therapy for Patients With Recurrent or Metastatic Breast Cancer
Lead Sponsor:
British Columbia Cancer Agency
Conditions:
Breast Cancer
Eligibility:
FEMALE
45+ years
Phase:
NA
Brief Summary
Purpose: To determine whether \[18F\]FES can predict clinical benefit (defined as complete response, partial response and stable disease ≥ 6 months) to fulvestrant (250 mg IM q 28 days) in post-menop...
Detailed Description
The majority of women diagnosed with breast cancer are post-menopausal, of which up to 75% are estrogen (ER) and/or progesterone receptor (PR) positive. Even in pre-menopausal breast cancer over half ...
Eligibility Criteria
Inclusion
- post-menopausal (≥ 60 years old, or age ≥ 45 years with amenorrhea for \> 12 months or follicle stimulating hormone and estrogen levels within post-menopausal range, or prior bilateral oophorectomy)
- hormone receptor positive (ER and/or PgR) disease as determined locally
- WHO performance status 0-2
- life expectancy of ≥ 3 months
- the presence of at least one measurable or evaluable (non-measurable) lesion
- informed consent prior to any study procedures
Exclusion
- life threatening metastatic visceral disease
- brain or leptomeningeal metastases
- prior exposure to fulvestrant
- history of bleeding diathesis or need for long term anti-coagulation
Key Trial Info
Start Date :
November 30 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2018
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT00816582
Start Date
November 30 2010
End Date
July 1 2018
Last Update
November 16 2021
Active Locations (4)
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1
BC Cancer Agency - Southern Interior
Kelowna, British Columbia, Canada, V1Y 5L3
2
BC Cancer Agency - Fraser Valley
Surrey, British Columbia, Canada, V3V 1Z2
3
BC Cancer Agency - Vancouver Centre
Vancouver, British Columbia, Canada, V5Z 4E6
4
BC Cancer Agency - Vancouver Island
Victoria, British Columbia, Canada, V8R 6V5