NCT00357110

Brief Summary

Purpose is to compare the frequency of events (presence of Disseminated Tumour Cells, clinical recurrence and/or death) after 1 and 2 years of adjuvant treatment with anastrozole and fulvestrant or anastrozole alone in patients with early breast cancer.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
13

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline
Completed

Started Apr 2006

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
3 countries

25 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

April 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2006

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2006

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

January 22, 2010

Completed
Last Updated

December 21, 2010

Status Verified

December 1, 2010

Enrollment Period

2.5 years

First QC Date

July 20, 2006

Results QC Date

December 18, 2009

Last Update Submit

December 3, 2010

Conditions

Breast Cancer

Keywords

Breast neoplasmsbreast cancerearly breast canceroncologycancerbreast cancer micrometastasisfulvestrant

Outcome Measures

Primary Outcomes (1)

  • Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)

    Number of patients event-free

    12 month period following randomisation

Study Arms (2)

1

ACTIVE COMPARATOR

Anastrozole monotherapy

Drug: Anastrozole

2

EXPERIMENTAL

Anastrozole + Fulvestrant

Drug: FulvestrantDrug: Anastrozole

Interventions

FulvestrantDRUG

intramuscular injection

Also known as: Faslodex, ZD9238
2
AnastrozoleDRUG

1 mg oral tablet

Also known as: Arimidex, ZD1033
12

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Postmenopausal women with hormone receptor-positive early breast cancer and a positive Disseminated Tumour Cell immunocytochemical result from bone marrow aspiration prior to randomisation

You may not qualify if:

  • Inflammatory and/or metastatic breast cancer.
  • Current or previous malignancy within previous 5 years (other than Breast cancer or adequately treated non-melanoma skin cancer or in-situ cervical cancer).
  • History of bleeding diathesis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Research Site

Feldkirch, Austria

Location

Research Site

Graz, Austria

Location

Research Site

Innsbruck, Austria

Location

Research Site

Klagenfurt, Austria

Location

Research Site

Leoben, Austria

Location

Research Site

Linz, Austria

Location

Research Site

Salzburg, Austria

Location

Research Site

Sankt Veit im Pongau, Austria

Location

Research Site

Vienna, Austria

Location

Research Site

Wiener Neustadt, Austria

Location

Research Site

Bayreuth, Germany

Location

Research Site

Essen, Germany

Location

Research Site

Hamburg-Eppendorf, Germany

Location

Research Site

Heidelberg, Germany

Location

Research Site

Munich, Germany

Location

Research Site

Rostock, Germany

Location

Research Site

Tübingen, Germany

Location

Research Site

Drammen, Norway

Location

Research Site

Fredrikstad, Norway

Location

Research Site

Kristiansand, Norway

Location

Research Site

Oslo, Norway

Location

Research SIte

Porsgrunn, Norway

Location

Research Site

Stavanger, Norway

Location

Research Site

Trondheim, Norway

Location

Research Site

Tønsberg, Norway

Location

MeSH Terms

Conditions

Breast NeoplasmsNeoplasms

Interventions

FulvestrantAnastrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast 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

Results Point of Contact

Title
Gerard Lynch
Organization
AstraZeneca
aztrial_results_posting@astrazeneca.com

Study Officials

  • Breast Cancer Established Brands Team Medical Science Director, MD

    AstraZeneca

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

July 20, 2006

First Posted

July 27, 2006

Study Start

April 1, 2006

Primary Completion

October 1, 2008

Study Completion

October 1, 2008

Last Updated

December 21, 2010

Results First Posted

January 22, 2010

Record last verified: 2010-12

Locations

NO(8)AU(10)DE(7)