Tamoxifen in Treating Women With Breast Cancer - Full Text View

Sponsor:	University Hospital Birmingham
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00003678

Purpose

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by blocking the uptake of estrogen by the tumor cells.

PURPOSE: Randomized phase III trial to compare the effectiveness of at least 2 years of tamoxifen with that of 5 additional years of tamoxifen in treating women who have breast cancer that has been surgically removed.

Condition	Intervention	Phase
Breast Cancer	Drug: tamoxifen citrate Procedure: adjuvant therapy	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Active Control
Official Title:	A Large, Uniquely Simple, Randomised Study to Assess Much More Reliably the Balance of Benefits and Risks of Prolonging Adjuvant Tamoxifen Treatment in Early Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Tamoxifen Tamoxifen citrate

U.S. FDA Resources

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

All-cause mortality [ Designated as safety issue: No ]

Secondary Outcome Measures:

Disease recurrence [ Designated as safety issue: No ]
Death due to breast cancer, other primary tumors, or cardiovascular causes [ Designated as safety issue: No ]

Estimated Enrollment:	20000
Study Start Date:	May 1991

Detailed Description:

OBJECTIVES:

Compare the disease-free and overall survival of women with early breast cancer who are randomized to discontinue adjuvant tamoxifen vs those randomized to continue for at least 5 additional years.

OUTLINE: This is a randomized study. Patients are stratified for analysis according to duration of tamoxifen given before randomization (2-3 years vs 4-5 years vs 6-7 years vs 8-9 years vs 10 years and over), age (less than 49 vs over 50), and important prognostic factors, including tumor type and grade and nodal and estrogen receptor status. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients discontinue tamoxifen after at least 2 years of prior treatment.
Arm II: Patients continue treatment with tamoxifen for at least 5 additional years in the absence of unacceptable toxicity or disease progression.

Patients are followed annually.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 8,000-20,000 patients will be accrued for this study.

Eligibility

Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed breast carcinoma that has been completely excised
- Clinically relapse free
Must have completed at least two years of adjuvant therapy with tamoxifen for early breast cancer AND have no clear indication for or against receiving further tamoxifen
No significant endometrial hyperplasia
No patients with negligibly low risk of breast cancer death
Hormone receptor status:
- Any status allowed

PATIENT CHARACTERISTICS:

Age:

Not specified

Sex:

Female

Menopausal status:

Any status allowed

Performance status:

Not specified

Life expectancy:

Not specified

Hematopoietic:

Not specified

Hepatic:

Not specified

Renal:

Not specified

Other:

No other life threatening disease
No retinopathy
No psychiatric disorder or other condition that would preclude study compliance
No serious toxicity (e.g., depression) thought to be due to tamoxifen
Not pregnant or nursing
Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

Not specified

Chemotherapy:

Not specified

Endocrine therapy:

See Disease Characteristics

Radiotherapy:

Not specified

Surgery:

See Disease Characteristics

Other:

Any primary treatment allowed

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003678

Locations

United Kingdom, England
Cancer Research UK Clinical Trials Unit - Birmingham
Birmingham, England, United Kingdom, B15 2TT

Sponsors and Collaborators

University Hospital Birmingham

Investigators

Study Chair:

Daniel Rea, MD

University Hospital Birmingham

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Publications:

Gray R, Davies C, Perry P. Tamoxifen for early breast cancer: better late than never. Ann Oncol. 2000 May;11(5):505-7. No abstract available.

Rea D, Poole C, Gray R. Adjuvant tamoxifen: how long before we know how long? BMJ. 1998 May 16;316(7143):1518-9. Review. No abstract available.

Earl H, Gray R, Kerr D, Lee M. The optimal duration of adjuvant tamoxifen treatment for breast cancer remains uncertain: randomize into aTTom. Clin Oncol (R Coll Radiol). 1997;9(3):141-3. No abstract available.

Earl H, Baker P, Kerr D, Lee M, Gray R, Baum M. Adjuvant treatment with tamoxifen. Recruitment into studies assessing optimum duration of treatment must continue. BMJ. 1996 Apr 20;312(7037):1036-7. No abstract available.

Gray R. Tamoxifen: how boldly to go where no women have gone before. J Natl Cancer Inst. 1993 Sep 1;85(17):1358-60. No abstract available.

Study ID Numbers:	CDR0000066779, CRC-TU-ATTOM, EU-98042, ISRCTN17222211
Study First Received:	November 1, 1999
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00003678 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I breast cancer
stage II breast cancer

Additional relevant MeSH terms:

Estrogen Antagonists
Skin Diseases
Immunologic Factors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Hormone Antagonists
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Adjuvants, Immunologic
Breast Neoplasms

Bone Density Conservation Agents
Selective Estrogen Receptor Modulators
Tamoxifen
Pharmacologic Actions
Estrogen Receptor Modulators
Neoplasms
Neoplasms by Site
Therapeutic Uses
Breast Diseases

ClinicalTrials.gov processed this record on November 09, 2009