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Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00944918
First received: July 22, 2009
Last updated: August 26, 2011
Last verified: August 2011

July 22, 2009
August 26, 2011
December 2008
June 2011   (final data collection date for primary outcome measure)
Progression-free survival [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ] [ Designated as safety issue: No ]
Progression-free survival [ Time Frame: Per RECIST schedule ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00944918 on ClinicalTrials.gov Archive Site
  • Objective complete response (CR) and partial response (PR) rate [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ] [ Designated as safety issue: No ]
  • Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ] [ Designated as safety issue: No ]
  • Objective complete response (CR) and partial response (PR) rate [ Time Frame: Per RECIST schedule ] [ Designated as safety issue: No ]
  • Duration of response [ Time Frame: Per RECIST schedule ] [ Designated as safety issue: No ]
  • Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate [ Time Frame: Per RECIST schedule ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)
A Partially-blind Phase III Randomised Trial of Fulvestrant (Faslodex) With or Without Concomitant Anastrozole (Arimidex) Compared With Exemestane in Postmenopausal Women With ER+ve Locally Advanced/Metastatic Breast Cancer Following Progression on Non-steroidal Aromatase Inhibitors

A partially-blind, randomised, multicentre phase III trial of Faslodex plus concomitant Arimidex versus Faslodex plus Arimidex-Placebo versus exemestane in postmenopausal locally advanced / metastatic breast cancer patients who have progressed on NSAIs. Randomisation to Faslodex ± Arimidex / Arimidex-Placebo or exemestane will be open (1:1:1). For Faslodex treated patients the randomisation to Arimidex or Arimidex-Placebo will be double-blind.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Progression-free Survival
  • Drug: fulvestrant
    Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
    Other Name: Faslodex
  • Drug: anastrozole
    Tablet, oral, once daily until disease progression.
    Other Name: Arimidex
  • Drug: exemestane
    Tablet, oral, once daily until disease progression.
    Other Name: Aromasin
  • Experimental: 1
    fulvestrant and anastrozole
    Interventions:
    • Drug: fulvestrant
    • Drug: anastrozole
  • Experimental: 2
    fulvestrant and placebo
    Intervention: Drug: fulvestrant
  • Active Comparator: 3
    exemestane alone
    Intervention: Drug: exemestane
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
June 2011
June 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Histologically or cytologically confirmed adenocarcinoma of the breast.
  • Metastatic disease must be measurable or evaluable
  • Relapsed or progressed during prior treatment with single-agent NSAI, meeting either of the following criteria:
  • NSAI given as adjuvant therapy that lasted ≥ 12 months OR
  • Achieved an objective CR, PR, or SD that that lasted ≥ 6 months after prior 1st-line
  • Female postmenopausal patients

Exclusion Criteria:

  • Hormone receptor status1. ER -ve and PgR NK2. ER-ve and PgR -ve3. ER NK
  • Prescribed Tamoxifen for metastatic disease
  • Rapidly progressive visceral disease
  • Patients with malignancies within the last 5 years.
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00944918
9238UK/0005
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Young-Huck Im Professor(Samsung Medical Center)
AstraZeneca
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP