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NCT00016432 · ClinicalTrials.gov registry record · Phase 3

Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen

A Phase 3 study of Breast Cancer, sponsored by NSABP Foundation.

Completed
Registry status
Phase 3
Development phase
1,598
Enrollment target
20
Study locations

NCT00016432: Completed Phase 3 study of Breast Cancer, sponsored by NSABP Foundation.

NCT00016432 is a Phase 3 study of Breast Cancer that has completed, run by NSABP Foundation. The registered enrollment target is 1,598 participants, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (43% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00016432, a Phase 3 study of Breast Cancer, has completed, sponsored by NSABP Foundation.

COMPLETED
Registry status
Phase 3
Development phase
1,598 participants
Enrollment target
20
Study locations

Study Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer. PURPOSE: Randomized phase III trial to study the effectiveness of exemestane in preventing cancer recurrence in postmenopausal women who have resected stage I, stage II, or stage IIIA breast cancer and have completed 5 years of tamoxifen.

Conditions Studied

Interventions

  • DRUG Placebo
  • DRUG exemestane

Study Locations (20)

California

  • City of Hope Comprehensive Cancer Center - Duarte
  • California Cancer Center - Fresno
  • Sutter Health Western Division Cancer Research Group - Greenbrae
  • Scripps Cancer Center - La Jolla
  • Rebecca and John Moores UCSD Cancer Center - La Jolla
  • Loma Linda University Cancer Institute - Loma Linda
  • Pacific Shores Medical Group - Long Beach
  • Jonsson Comprehensive Cancer Center, UCLA - Los Angeles
  • Chao Family Comprehensive Cancer Center - Orange
  • Comprehensive Cancer Centers of the Desert - Palm Springs
  • Sutter Cancer Center - Sacramento
  • Kaiser Permanente Medical Center/Kaiser Foundation Hospital - San Diego - San Diego
  • CCOP - Santa Rosa Memorial Hospital - Santa Rosa
  • Stanford University Medical Center - Stanford
  • Kaiser Permanente Medical Center - Vallejo - Vallejo

Colorado

  • University of Colorado Cancer Center - Denver
  • CCOP - Colorado Cancer Research Program, Incorporated - Denver

Alabama

  • Comprehensive Cancer Institute of Huntsville - Huntsville

Arizona

  • CCOP - Greater Phoenix - Phoenix

Arkansas

  • University of Arkansas for Medical Sciences - Little Rock

Trial Details

FieldValue
Enrollment Target 1,598 participants
Start Date 2001-05
Est. Completion 2011-02
Phase Phase 3
NSABP Foundation

44 total trials

What the finished NCT00016432 record still lists

NCT00016432 is an interventional study that assigns participants to a tested intervention. Its 1,598 participants enrollment target places it among the larger protocols in the corpus, below the 2,802-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (43% lower).

The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT00016432 names 20 study sites across 5 states, led by California, Colorado, Alabama.

Frequently Asked Questions

What is clinical trial NCT00016432 about?

NCT00016432 is a clinical study titled "Exemestane in Treating Postmenopausal Women With Resected Stage I, Stage II, or Stage IIIA Breast Cancer Who Have Completed 5 Years of Tamoxifen". RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen by the tumor cells. It is not yet known whether exemestane is effective in preventing the recurrence of breast cancer. PURPOSE: Random...

What is the current status of trial NCT00016432?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,598 participants. The study started on 2001-05. Estimated completion is 2011-02.

What conditions does trial NCT00016432 study?

This clinical trial studies the following conditions: Breast Cancer.

What interventions are being tested in trial NCT00016432?

The interventions under investigation include: Placebo (DRUG), exemestane (DRUG).

Who is sponsoring clinical trial NCT00016432?

This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00016432 being conducted?

This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Breast Cancer

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT00016432's enrollment target sits among peer trials

1,598 81st of 1224 higher than 1,144 of 1,224 other Breast Cancer trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00016432, the US trial registry maintained by the National Library of Medicine. NCT00016432 (large enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.