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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00944918

Enrollment

Registered

2009-07-23

Start date

2008-12-31

Completion date

2011-06-30

Last updated

2011-08-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Progression-free Survival

Keywords

Breast Cancer

Brief 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.

Interventions

DRUGfulvestrant

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

DRUGanastrozole

Tablet, oral, once daily until disease progression.

DRUGexemestane

Tablet, oral, once daily until disease progression.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Progression-free survival	every 3 months during treatment and, at time of discontinuation from treatment

Secondary

Measure	Time frame
Objective complete response (CR) and partial response (PR) rate	every 3 months during treatment and, at time of discontinuation from treatment
Duration of response	every 3 months during treatment and, at time of discontinuation from treatment
Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate	every 3 months during treatment and, at time of discontinuation from treatment

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 23, 2026