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

Tracking Information

First Received Date ^ICMJE

November 1, 1999

Last Updated Date

February 6, 2009

Start Date ^ICMJE

October 1995

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Overall survival (i.e., all-cause mortality) [ Designated as safety issue: No ]

Original Primary Outcome Measures ^ICMJE

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

Change History

Complete list of historical versions of study NCT00003016 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Specific-cause mortality [ Designated as safety issue: No ]
Incidence of second primary tumors [ Designated as safety issue: No ]

Original Secondary Outcome Measures ^ICMJE

Specific-cause mortality
Incidence of second primary tumors

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer.

PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor removed.

Detailed Description

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.

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.

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

Study Phase

Phase III

Study Type ^ICMJE

Interventional

Study Design ^ICMJE

Treatment, Randomized, Active Control

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Drug: tamoxifen citrate
Procedure: adjuvant therapy

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

20000

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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)

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

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

Gender

Both

Ages

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United Kingdom

Administrative Information

NCT ID ^ICMJE

NCT00003016

Responsible Party

Study ID Numbers ^ICMJE

CDR0000065596, ATLAS, EU-96064

Study Sponsor ^ICMJE

University of Oxford

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Rodrigo Arriagada, MD

Karolinska University Hospital - Solna

Information Provided By

National Cancer Institute (NCI)

Verification Date

October 2002

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP