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

Progression-free Survival Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00944918
• Other study ID #: 9238UK/0005
• Status: Completed
• Phase: Phase 3
• First received: July 22, 2009
• Last updated: August 26, 2011
• Start date: December 2008
• Est. completion date: June 2011

Study information

• Verified date: August 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Disease Progression
• Progression-free Survival

Intervention

Drug:
• fulvestrant
Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
• anastrozole
Tablet, oral, once daily until disease progression.
• exemestane
Tablet, oral, once daily until disease progression.

Locations

Country	Name	City	State
Korea, Republic of	Research Site	Ilsan
Korea, Republic of	Research Site	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression-free survival		every 3 months during treatment and, at time of discontinuation from treatment	No
Secondary	Objective complete response (CR) and partial response (PR) rate		every 3 months during treatment and, at time of discontinuation from treatment	No
Secondary	Duration of response		every 3 months during treatment and, at time of discontinuation from treatment	No
Secondary	Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate		every 3 months during treatment and, at time of discontinuation from treatment	No