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

Phase 2

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Anastrozole; Drug: Fulvestrant

• Registration Number: NCT00357110
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2006-04
• Study First Submitted: 2006-07-20
• Study First Submitted QC: 2006-07-26
• Study First Posted: 2006-07-27
• Primary Completion: 2008-10
• Study Completion: 2008-10
• Results First Submitted: 2009-12-18
• Results First Submitted QC: 2009-12-18
• Results First Posted: 2010-01-22
• Status Verified: 2010-12
• Last Update Submitted: 2010-12-03
• Last Update Posted: 2010-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 13

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Anastrozole	Anastrozole monotherapy
2	Fulvestrant	Anastrozole + Fulvestrant
2	Anastrozole	Anastrozole + Fulvestrant

Primary Outcome Measures

Name	Time	Method
Patients Event-free at 12 Months (Where Event = Death (From Any Cause), Disseminated Tumour Cells (DTC) Positive at 12 Months or Clinical Disease Recurrence)	12 month period following randomisation	Number of patients event-free

Trial Locations

Locations (2)

Research SIte; 🇳🇴 Porsgrunn, Norway

Research Site; 🇳🇴 Trondheim, Norway