NCT00944918

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Dec 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 22, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 23, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

August 29, 2011

Status Verified

August 1, 2011

Enrollment Period

2.5 years

First QC Date

July 22, 2009

Last Update Submit

August 26, 2011

Conditions

Progression-free Survival

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Progression-free survival

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

Secondary Outcomes (3)

  • 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

Study Arms (3)

1

EXPERIMENTAL

fulvestrant and anastrozole

Drug: fulvestrantDrug: anastrozole

2

EXPERIMENTAL

fulvestrant and placebo

Drug: fulvestrant

3

ACTIVE COMPARATOR

exemestane alone

Drug: exemestane

Interventions

fulvestrantDRUG

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

Also known as: Faslodex
12
anastrozoleDRUG

Tablet, oral, once daily until disease progression.

Also known as: Arimidex
1
exemestaneDRUG

Tablet, oral, once daily until disease progression.

Also known as: Aromasin
3

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Research Site

Ilsan, South Korea

Location

Research Site

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 23902874DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FulvestrantAnastrozoleexemestane

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNitrilesOrganic ChemicalsTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Young-Huck Im

    Professor(Samsung Medical Center)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 22, 2009

First Posted

July 23, 2009

Study Start

December 1, 2008

Primary Completion

June 1, 2011

Study Completion

June 1, 2011

Last Updated

August 29, 2011

Record last verified: 2011-08

Locations

KR(2)