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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
History of Changes
  Purpose

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.


Condition Intervention Phase
Progression-free Survival
 Drug: fulvestrant
Drug: anastrozole
Drug: exemestane
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: every 3 months during treatment and, at time of discontinuation from treatment ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 25
Study Start Date: December 2008
Study Completion Date: June 2011
Primary Completion Date: June 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
fulvestrant and anastrozole
 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
Experimental: 2
fulvestrant and placebo
 Drug: fulvestrant
Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
Other Name: Faslodex
Active Comparator: 3
exemestane alone
 Drug: exemestane
Tablet, oral, once daily until disease progression.
Other Name: Aromasin

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00944918

Locations
Korea, Republic of
Research Site
Ilsan, Korea, Republic of
Research Site
Seoul, Korea, Republic of
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Young-Huck Im Professor(Samsung Medical Center)
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00944918     History of Changes
Other Study ID Numbers: 9238UK/0005
Study First Received: July 22, 2009
Last Updated: August 26, 2011
Health Authority: Korea: Food and Drug Administration

Keywords provided by AstraZeneca:
Breast Cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Fulvestrant
Anastrozole
Aromatase Inhibitors
Antineoplastic Agents
 Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal

ClinicalTrials.gov processed this record on May 22, 2013