Back to resultsStudy of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)
Primary Purpose
Progression-free Survival
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
fulvestrant
anastrozole
exemestane
Sponsored by
About this trial
This is an interventional treatment trial for Progression-free Survival focused on measuring Breast Cancer
Eligibility 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.
Sites / Locations
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
1
2
3
Arm Description
fulvestrant and anastrozole
fulvestrant and placebo
exemestane alone
Outcomes
Primary Outcome Measures
Progression-free survival
Secondary Outcome Measures
Objective complete response (CR) and partial response (PR) rate
Duration of response
Clinical benefit (i.e., 6-month CR, PR, and stable disease) rate
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00944918
Brief Title
Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progression-free Survival
Keywords
Breast Cancer
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Arm Description
fulvestrant and anastrozole
Arm Title
2
Arm Type
Experimental
Arm Description
fulvestrant and placebo
Arm Title
3
Arm Type
Active Comparator
Arm Description
exemestane alone
Intervention Type
Drug
Intervention Name(s)
fulvestrant
Other Intervention Name(s)
Faslodex
Intervention Description
Intramuscular injection on days 1, 15, and 29 and then once monthly until disease progression.
Intervention Type
Drug
Intervention Name(s)
anastrozole
Other Intervention Name(s)
Arimidex
Intervention Description
Tablet, oral, once daily until disease progression.
Intervention Type
Drug
Intervention Name(s)
exemestane
Other Intervention Name(s)
Aromasin
Intervention Description
Tablet, oral, once daily until disease progression.
Primary Outcome Measure Information:
Title
Progression-free survival
Time Frame
every 3 months during treatment and, at time of discontinuation from treatment
Secondary Outcome Measure Information:
Title
Objective complete response (CR) and partial response (PR) rate
Time Frame
every 3 months during treatment and, at time of discontinuation from treatment
Title
Duration of response
Time Frame
every 3 months during treatment and, at time of discontinuation from treatment
Title
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
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-Huck Im
Organizational Affiliation
Professor(Samsung Medical Center)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Ilsan
Country
Korea, Republic of
Facility Name
Research Site
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Citations:
PubMed Identifier
23902874
Citation
Johnston SR, Kilburn LS, Ellis P, Dodwell D, Cameron D, Hayward L, Im YH, Braybrooke JP, Brunt AM, Cheung KL, Jyothirmayi R, Robinson A, Wardley AM, Wheatley D, Howell A, Coombes G, Sergenson N, Sin HJ, Folkerd E, Dowsett M, Bliss JM; SoFEA investigators. Fulvestrant plus anastrozole or placebo versus exemestane alone after progression on non-steroidal aromatase inhibitors in postmenopausal patients with hormone-receptor-positive locally advanced or metastatic breast cancer (SoFEA): a composite, multicentre, phase 3 randomised trial. Lancet Oncol. 2013 Sep;14(10):989-98. doi: 10.1016/S1470-2045(13)70322-X. Epub 2013 Jul 29.
Results Reference
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Study of Faslodex With or Without Concomitant Arimidex Versus Exemestane Following Progression on Non-steroidal Aromatase Inhibitors (NSAI)
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