Anastrozole and Fulvestrant Compared to Anastrozole as Adjuvant Treatment of Postmenopausal Patients With Breast Cancer

Breast Cancer Clinical Trial

— @FAME  

Official title:

A Randomised Phase II Study Comparing Anastrozole and Fulvestrant to Anastrozole for Adjuvant Treatment of Postmenopausal Patients With Early Breast Cancer and Disseminated Tumour Cells in Bone Marrow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00357110
• Other study ID #: D6990C00001
• Secondary ID: ABCSG21Eudract N
• Status: Completed
• Phase: Phase 2
• First received: July 20, 2006
• Last updated: December 3, 2010
• Start date: April 2006
• Est. completion date: October 2008

Study information

• Verified date: December 2010
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Federal Ministry for Health and WomenGermany: Federal Institute for Drugs and Medical DevicesNorway: Norwegian Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: October 2008
• Est. primary completion date: October 2008
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Fulvestrant
intramuscular injection
• Anastrozole
1 mg oral tablet

Locations

Country	Name	City	State
Austria	Research Site	Feldkirch
Austria	Research Site	Graz
Austria	Research Site	Innsbruck
Austria	Research Site	Klagenfurt
Austria	Research Site	Leoben
Austria	Research Site	Linz
Austria	Research Site	Salzburg
Austria	Research Site	St. Veit
Austria	Research Site	Wien
Austria	Research Site	Wiener Neustadt
Germany	Research Site	Bayreuth
Germany	Research Site	Essen
Germany	Research Site	Hamburg-Eppendorf
Germany	Research Site	Heidelberg
Germany	Research Site	Munich
Germany	Research Site	Rostock
Germany	Research Site	Tubingen
Norway	Research Site	Drammen
Norway	Research Site	Fredrikstad
Norway	Research Site	Kristiansand
Norway	Research Site	Oslo
Norway	Research SIte	Porsgrunn
Norway	Research Site	Stavanger
Norway	Research Site	Tonsberg
Norway	Research Site	Trondheim

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Austria,  Germany,  Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No