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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2002 by National Cancer Institute (NCI).
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00003016
First received: November 1, 1999
Last updated: February 6, 2009
Last verified: October 2002
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: tamoxifen citrate
Procedure: adjuvant therapy
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Primary Purpose: Treatment
Official Title: Reliable Assessment of the Efficacy and Safety of Prolonging the Use of Adjuvant Tamoxifen: A Large, Simple, Randomised Study

Resource links provided by NLM:


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

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

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

Estimated Enrollment: 20000
Study Start Date: October 1995
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00003016

Locations
United Kingdom
Atlas Trial Office
Oxford, England, United Kingdom, OX2 6HE
Sponsors and Collaborators
University of Oxford
Investigators
Study Chair: Rodrigo Arriagada, MD Karolinska Institutet
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00003016     History of Changes
Other Study ID Numbers: CDR0000065596, ATLAS, EU-96064
Study First Received: November 1, 1999
Last Updated: February 6, 2009
Health Authority: United States: Federal Government

Keywords provided by National Cancer Institute (NCI):
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
Selective Estrogen Receptor Modulators
Bone Density Conservation Agents

ClinicalTrials.gov processed this record on August 26, 2014