Different Durations of Adjuvant Anastrozole Therapy After 2 to 3 Years Tamoxifen Therapy in Breast Cancer

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Anastrozole

• Registration Number: NCT00301457
• Lead Sponsor: Maastricht University Medical Center

Brief Summary

The purpose of this study is to determine whether 6 years adjuvant anastrozole will improve the disease free survival compared to 3 years adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2-3 years tamoxifen

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2006-03-09
• Study First Submitted QC: 2006-03-09
• Study First Posted: 2006-03-13
• Study Start: 2006-06
• Primary Completion: 2022-04
• Study Completion: 2022-04
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-17
• Last Update Posted: 2023-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 1914

Inclusion Criteria

• postmenopausal patients with hormone receptor positive breast cancer who have already received 2 to 3 years of adjuvant tamoxifen, and who never had signs of loco-regional recurrences or distant metastasis

Exclusion Criteria

• Previous hormonal therapy as adjuvant breast cancer treatment besides tamoxifen.
• Previous history of invasive breast cancer within the last 10 years, other then the breast cancer that is currently treated with tamoxifen

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Anastrozole	6 years adjuvant anastrozole therapy
2	Anastrozole	3 years adjuvant anastrozole therapy

Primary Outcome Measures

Name	Time	Method
To assess the disease free survival (DFS) with 6 years of adjuvant anastrozole compared with 3 years of adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2 to 3 years of adjuvant tamoxifen	After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen

Secondary Outcome Measures

Name	Time	Method
To compare the incidence of contralateral breast cancer after 6 years versus 3 years adjuvant anastrozole, subsequent to 2 to 3 years of tamoxifen	After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen
To compare the overall survival after 6 years versus 3 years adjuvant anastrozole, subsequent to 2 to 3 years of tamoxifen	After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen
To compare toxicity of 6 years versus 3 years of adjuvant anastrozole in postmenopausal hormone sensitive breast cancer patients, subsequent to 2 to 3 years of tamoxifen	After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen
To determine regional differences in the initial treatment of breast cancer retrospectively by collecting baseline information on initial therapies.	After 9 years	Aspects of the initial treatment that will be investigated are e.g. the kind of surgery performed (breast saving or mastectomy) and whether or not chemotherapy is given and which chemotherapy was used in postmenopausal patients in relation to the primary tumour and patient characteristics.
To compare the cost effectiveness of 3 years versus 6 years adjuvant anastrozole therapy, after subsequent 2 to 3 years of adjuvant tamoxifen treatment.	After 9 years for the group with 6 years of adjuvant anastrozol, subsequent to 2 to 3 years of adjuvant tamoxifen or after 6 years for the group with 3 years of adjuvant anastrozole subsequent to 2 to 3 years of adjuvant tamoxifen
To assess patterns of care in The Netherlands in prevention, detection and treatment of osteoporosis in postmenopausal women with breast cancer treated with adjuvant anastrozole.	After 9 years
To relate the number of osteoporotic fractures during and following treatment with adjuvant anastrozole with the compliance to osteoporotic guidelines.	After 9 years
To analyse occurrence of distant (bone) metastases in relation to occurrence of osteopenia and osteoporosis, and in relation to use of supplements and therapy for reduced BMD.	After 9 years

Trial Locations

Locations (1)

Research Site; 🇳🇱 Zwolle, Netherlands