Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT00009945 · ClinicalTrials.gov registry record · Phase 3
Clodronate With or Without Chemotherapy and/or Hormonal Therapy in Treating Women With Stage I or Stage II Breast Cancer
A Phase 3 study, sponsored by NSABP Foundation.
- Completed
- Registry status
- Phase 3
- Development phase
- 3,323
- Enrollment target
NCT00009945: Completed Phase 3 study, sponsored by NSABP Foundation.
NCT00009945 is a Phase 3 study that has completed, run by NSABP Foundation. The registered enrollment target is 3,323 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (330% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00009945, a Phase 3 study, has completed, sponsored by NSABP Foundation.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 3,323 participants
- Enrollment target
Study Summary
RATIONALE: Clodronate may be effective in preventing the spread of cancer to the bones and other parts of the body. It is not yet known whether clodronate is more effective alone or combined with chemotherapy and /or hormonal therapy in preventing metastatic breast cancer. PURPOSE: Randomized phase III trial to determine the effectiveness of clodronate with or without chemotherapy and /or hormonal therapy in preventing metastases in women who have stage I or stage II breast cancer.
Primary Outcome
Time to first event where an event is any recurrences, 2nd primary or death to determine the percentage of patients disease free at 8 years
Interventions
- DRUG placebo
- DRUG clodronate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3,323 participants |
| Start Date | 2001-01 |
| Est. Completion | 2012-12 |
| Phase | Phase 3 |
What the finished NCT00009945 record still lists
NCT00009945 is an interventional study that assigns participants to a tested intervention. Its 3,323 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (330% higher).
The record links to 0 conditions, and to 2 interventions - of which placebo is the first listed.
NCT00009945 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00009945 about?
NCT00009945 is a clinical study titled "Clodronate With or Without Chemotherapy and/or Hormonal Therapy in Treating Women With Stage I or Stage II Breast Cancer". RATIONALE: Clodronate may be effective in preventing the spread of cancer to the bones and other parts of the body. It is not yet known whether clodronate is more effective alone or combined with chemotherapy and /or hormonal therapy in preventing metastatic breast cancer. PURPOSE: Randomized phase...
What is the current status of trial NCT00009945?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 3,323 participants. The study started on 2001-01. Estimated completion is 2012-12.
What interventions are being tested in trial NCT00009945?
The interventions under investigation include: placebo (DRUG), clodronate (DRUG).
Who is sponsoring clinical trial NCT00009945?
This trial is sponsored by NSABP Foundation, which has 44 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00009945's enrollment target sits among peer trials
3,323 72nd of 2000 higher than 1,929 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03674307 · 3,306 participants · NA
Screening for Asymptomatic Coronary Artery Disease in Kidney Transplant Candidates
- NCT07214610 · 3,300 participants · NA
Integrating Biological, Clinical, and Behavioral Factors to Improve Breast Cancer Outcomes - Carolina Breast Cancer Study
- NCT06815536 · 3,291 participants
Master Protocol for Evaluating Multiple Infection Diagnostics for Ciprofloxacin-Resistant Neisseria Gonorrhoeae
- NCT06543446 · 3,290 participants · NA
Comparative Effectiveness of Prophylactic ICD Versus Non-ICD Therapy
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia