Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
N/A
N/A
Female
Advanced Breast Cancer, Metastatic Breast Cancer
Trial Information
Phase II Study to Evaluate the Efficacy and Tolerability of Fulvestrant 250mg, 250mg (Plus 250mg Loading Regimen) and 500mg in Postmenopausal Women With ER +ve Advanced Breast Cancer Progressing or Relapsing After Previous Endocrine Therapy
Inclusion Criteria:
- Breast Cancer has continued to grow after having received treatment with an
anti-estrogen hormonal treatment such as tamoxifen or an aromatase inhibitor
- Requiring hormonal treatment
- Postmenopausal women defined as a woman who has stopped having menstrual periods
Exclusion Criteria:
- Treatment with more than one previous regimen of systemic anticancer therapy other
than endocrine therapy for advanced breast cancer
- Treatment with more than one previous regimen of endocrine therapy for advanced
breast cancer
- An existing serious disease, illness, or condition that will prevent participation or
compliance with study procedures
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Outcome Measure:
Objective Response Rate (ORR)
Outcome Description:
An objective response (OR) is defined as a patient having a best overall response of either complete response (CR) or partial response (PR). A patient has best overall response of CR if she had overall response of CR or PR on one visit and met the confirmation criteria per RECIST. ORR is defined as percentage of patients with objective response. Each patient with measurable disease at baseline was assessed for OR from the sequence of Response Evaluation Criteria in Solid Tumors (RECIST) scan data up to data cut-off. RECIST scans were performed every 12 weeks (+/- 2weeks) from randomization
Outcome Time Frame:
baseline and every 12 weeks (+/- 2weeks) from randomization data up to data cut-off (19th march 2008)
Safety Issue:
No
Principal Investigator
AstraZeneca Japan Medical Director, MD
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
Japan: Pharmaceuticals and Medical Devices Agency
Study ID:
D6997C00004
NCT ID:
NCT00305448
Start Date:
March 2006
Completion Date:
February 2012
Related Keywords:
- Advanced Breast Cancer
- Metastatic Breast Cancer
- oncology
- cancer
- breast cancer
- Breast Neoplasms
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