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Phase III Randomized Study of Prolonged Versus Shorter Adjuvant Tamoxifen in Patients With Curatively Treated Breast Cancer

Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs
Phase III Treatment Closed Any age Other ATLAS
EU-96064, NCT00003016

Objectives

Assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least 5 years in patients with curatively treated breast cancer who have already had about 5 years of adjuvant tamoxifen.

Entry Criteria

Disease Characteristics:

Curatively treated carcinoma of the breast

Currently taking adjuvant tamoxifen
- Must be substantial uncertainty as to whether or not to continue tamoxifen (i.e., no clear indication or definite contraindication to further treatment with tamoxifen)

Prior/Concurrent Therapy:

Biologic therapy:

Prior biologic therapy allowed

Chemotherapy:

Prior chemotherapy allowed

Endocrine therapy:

See Disease Characteristics

Radiotherapy:

Prior radiotherapy allowed

Surgery:

Prior surgery allowed

Patient Characteristics:

Age:

Any age

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

Not pregnant or nursing
No contraindications to receiving tamoxifen
No other serious medical problems

Expected Enrollment

20000

Approximately 20,000 patients will be accrued for this study.

Outcomes

Primary Outcome(s)

Overall survival (i.e., all-cause mortality)

Secondary Outcome(s)

Specific-cause mortality
Incidence of second primary tumors

Outline

This is a randomized study. After about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years.

Patients are followed annually.

Trial Contact Information

Trial Lead Organizations

Atlas Trial Office

Rodrigo Arriagada, MD, Protocol chair
Ph: 468-5177-6054
Email: rodrigo.arriagada@ki.se

Registry Information

Official Title		Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study

Trial Start Date		1995-10-01

Registered in ClinicalTrials.gov		NCT00003016

Date Submitted to PDQ		1997-08-18

Information Last Verified		2002-10-23

Note: The purpose of most clinical trials listed in this database is to test new cancer treatments, or new methods of diagnosing, screening, or preventing cancer. Because all potentially harmful side effects are not known before a trial is conducted, dose and schedule modifications may be required for participants if they develop side effects from the treatment or test. The therapy or test described in this clinical trial is intended for use by clinical oncologists in carefully structured settings, and may not prove to be more effective than standard treatment. A responsible investigator associated with this clinical trial should be consulted before using this protocol.