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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:
ClinicalTrials.gov Identifier:
NCT00944918
First Posted: July 23, 2009
Last Update Posted: August 29, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
July 22, 2009
July 23, 2009
August 29, 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 ]
Progression-free survival [ Time Frame: Per RECIST schedule ]
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 ]
  • Duration of response [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ]
  • 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 ]
  • Objective complete response (CR) and partial response (PR) rate [ Time Frame: Per RECIST schedule ]
  • Duration of response [ Time Frame: Per RECIST schedule ]
  • Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate [ Time Frame: Per RECIST schedule ]
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
Intervention Model: Parallel Assignment
Masking: Double (Participant, 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
Johnston SR, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im YH, Braybrooke JP, Brunt AM, Cheung KL, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin HJ, Folkerd E, Dowsett M, Bliss JM; SoFEA investigators. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol. 2013 Sep;14(10):989-98. doi: 10.1016/S1470-2045(13)70322-X. Epub 2013 Jul 29.

*   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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
 
NCT00944918
9238UK/0005
No
Not Provided
Not Provided
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