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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


Phase 3
18 Years
N/A
Not Enrolling
Female
Progression-free Survival

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Trial Information

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


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Young-Huck Im

Investigator Role:

Principal Investigator

Investigator Affiliation:

Professor(Samsung Medical Center)

Authority:

Korea: Food and Drug Administration

Study ID:

9238UK/0005

NCT ID:

NCT00944918

Start Date:

December 2008

Completion Date:

June 2011

Related Keywords:

  • Progression-free Survival
  • Breast Cancer
  • Breast Neoplasms

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