NCT00272740

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

Trial Health

85
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
93

participants targeted

Target at P50-P75 for phase_2

Geographic Reach
2 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2000

Completed
5.8 years until next milestone

First Submitted

Initial submission to the registry

January 4, 2006

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 9, 2006

Completed
Last Updated

February 9, 2007

Status Verified

February 1, 2007

First QC Date

January 4, 2006

Last Update Submit

February 8, 2007

Conditions

Breast Neoplasms

Keywords

breast cancerfulvestrantFaslodexhormonotherapyaromatase inhibitor failureAdvanced breast cancer

Outcome Measures

Primary Outcomes (1)

  • Clinical Benefit Rate

Secondary Outcomes (6)

  • Duration of clinical benefit

  • Time to progression

  • Duration of response

  • Time to treatment failure

  • Safety and tolerability

  • +1 more secondary outcomes

Interventions

FulvestrantDRUG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Research Site

Leuven, Belgium

Location

Research Site

Aarau, Switzerland

Location

Research Site

Bern, Switzerland

Location

Research Site

Geneva, Switzerland

Location

Research Site

Lausanne, Switzerland

Location

Research Site

Mendrisio, Switzerland

Location

Research Site

Milano, Switzerland

Location

Research Site

Sankt Gallen, Switzerland

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • AstraZeneca Switzerland Medical Director, MD

    AstraZeneca

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

January 4, 2006

First Posted

January 9, 2006

Study Start

March 1, 2000

Last Updated

February 9, 2007

Record last verified: 2007-02

Locations

BE(1)CH(7)