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NCT01129336 · ClinicalTrials.gov registry record · Phase 4
Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients
A Phase 4 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 4
- Development phase
- 44
- Enrollment target
NCT01129336: Completed Phase 4 study, sponsored by Novartis Pharmaceuticals.
NCT01129336 is a Phase 4 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 44 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01129336, a Phase 4 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 44 participants
- Enrollment target
Study Summary
This study will evaluate zoledronic acid's anti-cancer effects and Circulating Tumor Cell (CTCs) measurements in patients with HER2-negative metastatic breast cancer without bone metastasis.
Primary Outcome
Complete Response (CR): disappearance of all target lesions. Any pathological lymph nodes (target or non-target) must have exhibited a reduction in short axis to \< 10 mm. Partial Response (PR): at least a 30% decrease in sum of diameters of target lesions, taking as reference the baseline sum of diameters. Progressive Disease (PD): at least 20% increase in sum of diameters of target lesions taking as reference the smallest sum on study accompanied by an absolute increase of at least 5 mm or app
Interventions
- DRUG Zoledronic acid
- DRUG Standard Therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2010-06 |
| Est. Completion | 2012-08 |
| Phase | Phase 4 |
What the finished NCT01129336 record still lists
NCT01129336 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 44 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (92% lower).
The record links to 0 conditions, and to 2 interventions - of which Zoledronic acid is the first listed.
NCT01129336 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01129336 about?
NCT01129336 is a clinical study titled "Effect of Zoledronic Acid as Anti-Cancer Treatment in Metastatic Breast Cancer Patients". This study will evaluate zoledronic acid's anti-cancer effects and Circulating Tumor Cell (CTCs) measurements in patients with HER2-negative metastatic breast cancer without bone metastasis.
What is the current status of trial NCT01129336?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 44 participants. The study started on 2010-06. Estimated completion is 2012-08.
What interventions are being tested in trial NCT01129336?
The interventions under investigation include: Zoledronic acid (DRUG), Standard Therapy (DRUG).
Who is sponsoring clinical trial NCT01129336?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01129336's enrollment target sits among peer trials
44 1363rd of 2000 higher than 630 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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