|
Main
|
|
Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
|
Register:
|
ClinicalTrials.gov |
|
Last refreshed on:
|
17 October 2012 |
|
Main ID: |
NCT00944918 |
|
Date of registration:
|
22/07/2009 |
|
Primary sponsor: |
|
|
Public title:
|
Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)
|
|
Scientific 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 |
|
Date of first enrolment:
|
December 2008 |
|
Target sample size:
|
25 |
|
Recruitment status: |
Completed |
|
URL:
|
http://clinicaltrials.gov/show/NCT00944918 |
|
Study type:
|
Interventional |
|
Study design:
|
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
|
|
|
Countries of recruitment
|
|
Korea, Republic of
| | | | | | | |
|
Contacts
|
|
Name:
|
Young-Huck Im |
|
Address:
|
|
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Professor(Samsung Medical Center) |
| | |
|
Key inclusion & exclusion 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.
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
|
|
Health Condition(s) or Problem(s) studied
|
|
Progression-free Survival
|
|
Intervention(s)
|
|
Drug: anastrozole
|
|
Drug: exemestane
|
|
Drug: fulvestrant
|
|
Primary Outcome(s)
|
|
Progression-free survival
[Time Frame: every 3 months during treatment and, at time of discontinuation from treatment]
|
|
Secondary Outcome(s)
|
|
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]
|
|
Duration of response
[Time Frame: every 3 months during treatment and, at time of discontinuation from treatment]
|
|
Objective complete response (CR) and partial response (PR) rate
[Time Frame: every 3 months during treatment and, at time of discontinuation from treatment]
|
|
Secondary ID(s)
|
|
9238UK/0005
|
|
Source(s) of Monetary Support
|
|
Please refer to primary and secondary sponsors
|
|