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Clinical Trials/NCT00272740
NCT00272740
Completed
Phase 2

An Open, Multicenter Phase II Trial Evaluating the Antitumour Efficacy of Faslodex® (Fulvestrant) in Postmenopausal Women With Advanced Breast Cancer Failing Non-Steroidal or Steroidal Aromatase Inhibitors

AstraZeneca1 site in 1 country93 target enrollmentMarch 2000
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ConditionsBreast Neoplasms
DrugsFulvestrant

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Breast Neoplasms
Sponsor
AstraZeneca
Enrollment
93
Locations
1
Primary Endpoint
Clinical Benefit Rate
Status
Completed
Last Updated
19 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSitesSimilar Trials

Overview

Brief Summary

The primary objective of the study is to assess the activity of fulvestrant in postmenopausal women with advanced breast cancer failing treatment with non-steroidal or steroidal aromatase inhibitors by estimating the Clinical Benefit Rate

Registry
clinicaltrials.gov
Start Date
March 2000
End Date
TBD
Last Updated
19 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Eligibility Criteria

Inclusion Criteria

  • •Histological/cytological confirmation of breast cancer
  • •progression under treatment with an aromatase inhibitor
  • •At least one measurable or non-measurable lesion

Exclusion Criteria

  • •Prior treatment for breast cancer with more than 2 different hormonal agents
  • •More than 1 chemotherapy for advanced disease
  • •Presence of life-threatening metastatic visceral disease

Outcomes

Primary Outcomes

Clinical Benefit Rate

Secondary Outcomes

  • Time to progression
  • Duration of clinical benefit
  • Duration of response
  • Time to treatment failure
  • Safety and tolerability
  • 6. clinical benefit rate according to HER2/neu status

Study Sites (1)

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