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Completed

NCT Number: NCT00944918

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

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.

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Key information

Conditions

Progression-Free Survival Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Research Site, Ilsan, South Korea

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Fulvestrant

Drug

Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.

Other names: Faslodex

Anastrozole

Drug

Tablet, oral, once daily until disease progression.

Other names: Arimidex

Exemestane

Drug

Tablet, oral, once daily until disease progression.

Other names: Aromasin

Primary outcomes

  1. Progression-free survival

    Time frame: every 3 months during treatment and, at time of discontinuation from treatment

Secondary outcomes

  1. Objective complete response (CR) and partial response (PR) rate

    Time frame: every 3 months during treatment and, at time of discontinuation from treatment

  2. Duration of response

    Time frame: every 3 months during treatment and, at time of discontinuation from treatment

  3. 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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Jul 23, 2009
Registry last updated
Aug 29, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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