CClinicalTrials.gg
Status unknownNCT00003016Updated Feb 9, 2009

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

A Phase 3 interventional study of tamoxifen citrate and adjuvant therapy in Breast Cancer, sponsored by University of Oxford. Status unknown at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2009-02-09.

Sponsored by University of Oxford · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Oct 2002), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
20,000
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Breast Cancer

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Keywords

  • stage I breast cancer
  • stage II breast cancer
  • stage IIIA breast cancer
  • stage IIIB breast cancer
  • stage IIIC breast cancer
03

In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 20,000 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

University of Oxford is the lead sponsor of 794 studies on the registry; 117 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Enrollment
20,000 participants (estimated)

Interventions

  • Drugtamoxifen citrate
  • Procedureadjuvant therapy
06

What researchers measure

Primary outcomes

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

Secondary outcomes

  1. Specific-cause mortality

  2. Incidence of second primary tumors

07

Study locations

1 site
  • Atlas Trial Office
    Oxford, England OX2 6HE, United Kingdom
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 9, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00003016
Lead sponsor
University of Oxford
First posted
Jan 27, 2003
Start date
Oct 1995
Last update
Feb 9, 2009

Study contacts

Rodrigo Arriagada, MD
study chair · Karolinska Institutet
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2002. You cannot join it, but the record below documents what was studied.

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