Adjuvant Tamoxifen Compared With Anastrozole in Treating Postmenopausal Women With Ductal Carcinoma In Situ

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: tamoxifen citrate; Drug: Anastrozole

• Registration Number: NCT00072462
• Lead Sponsor: Queen Mary University of London

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using either tamoxifen or anastrozole may fight breast cancer by blocking the use of estrogen. It is not yet known whether tamoxifen is more effective than anastrozole in preventing breast cancer after surgery for ductal carcinoma in situ.

PURPOSE: This randomized phase III trial is studying how well adjuvant tamoxifen works compared to anastrozole in treating postmenopausal women who have undergone surgery to remove ductal carcinoma in situ.

Detailed Description

OBJECTIVES:

Primary

* Compare the efficacy of adjuvant tamoxifen vs anastrozole, in terms of local control and prevention of contralateral disease, in postmenopausal women with locally excised ductal carcinoma in situ.

* Compare side effect profiles of these drugs in these patients.

Secondary

* Compare the efficacy of these drugs, according to the receptor status of the primary or recurrent cancer in these patients.

* Compare the rate of breast cancer recurrence and growth of new contralateral tumors after cessation of treatment with these drugs in these patients.

* Compare breast cancer mortality in patients treated with these drugs.

* Compare the effect of these drugs on other cancers, cardiovascular disease, fracture rates, and non-breast cancer deaths in these patients.

* Compare the tolerability and acceptability of side effects experienced by patients treated with these drugs.

OUTLINE: This is a randomized, double-blind, multicentre study. Patients are stratified according to participating centre. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive oral tamoxifen and oral placebo once daily.

* Arm II: Patients receive oral anastrozole and oral placebo once daily. In both arms, treatment continues for 5 years in the absence of disease recurrence or unacceptable toxicity.

Patients are followed annually for 5 years and a further 5 years (minimum) off treatment.

Peer Reviewed and Funded by Cancer Research UK. Sponsored by Queen Mary University of London

ACTUAL ACCRUAL: A total of 2,980 patients were accrued for this study over 9 years.

Study Timeline

• Study Start: 2003-09
• Study First Submitted: 2003-11-04
• Study First Submitted QC: 2003-11-05
• Study First Posted: 2003-11-06
• Primary Completion: 2015-12
• Study Completion: 2021-05-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-10-05
• Last Update Posted: 2021-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2980

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tamoxifen	tamoxifen citrate	-
Anastrozole	Anastrozole	-

Primary Outcome Measures

Name	Time	Method
Number of Participants With Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours	Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

Secondary Outcome Measures

Name	Time	Method
Number of Participants With ER+ Breast Cancer Recurrence, Including Recurrent DCIS and New Contralateral Tumours	Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Number of Participants With ER- Breast Cancer Recurrence	Date of the breast cancer occurrence is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Number of Breast Cancer Deaths	Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).
Number of Non-breast Cancer Deaths	Date of the death is defined as the date of the confirmation of the specific event (from randomisation to date of occurrence). Data presented is from randomisation to study completion, median follow-up was 11.6 years (IQR: 9.9-13.5).

Trial Locations

Locations (97)

Australia; 🇦🇺 Newcastle, Australia

Austrian Breast & Colorectal Cancer Study Group; 🇦🇹 Vienna, Austria

Belgium; 🇧🇪 Leuven, Belgium

Chile; 🇨🇱 Santiago, Chile

Institut Sainte Catherine; 🇫🇷 Avignon, France

Institut Bergonie; 🇫🇷 Bordeaux, France

Polyclinique Bordeaux Nord Aquitaine; 🇫🇷 Bordeaux, France

Clinique Tivoli; 🇫🇷 Bordeaux, France

CHU Hopital A. Morvan; 🇫🇷 Brest, France

Centre Regional Francois Baclesse; 🇫🇷 Caen, France

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