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NCT01528345 · ClinicalTrials.gov registry record · Phase 2
Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer
A Phase 2 study, sponsored by Novartis Pharmaceuticals.
- Terminated
- Registry status
- Phase 2
- Development phase
- 97
- Enrollment target
NCT01528345: Clinical Trial Phase 2 study, sponsored by Novartis Pharmaceuticals.
NCT01528345 is a Phase 2 study that was terminated before completion, run by Novartis Pharmaceuticals. The registered enrollment target is 97 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01528345, a Phase 2 study, was terminated before completion, sponsored by Novartis Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 97 participants
- Enrollment target
Study Summary
This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after prior endocrine therapy. Patients must undergo molecular pre-screening prior to entry.
Primary Outcome
PFS was defined as the time from the date of randomization to the date of the first radiologically documented disease progression or death due to any cause and was assessed based on RECIST v1.1. Responses include: Complete Response: Disappearance of all non-nodal target lesions; Partial Response: At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; Progressive Disease: At least a 20% increase in the sum of diameter of all measur
Interventions
- DRUG Fulvestrant
- DRUG Dovitinib
- DRUG Dovitinib Placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 97 participants |
| Start Date | 2012-04 |
| Est. Completion | 2015-04 |
| Phase | Phase 2 |
Why NCT01528345 stopped before completion
NCT01528345 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 97 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% lower).
The record links to 0 conditions, and to 3 interventions - of which Fulvestrant is the first listed.
NCT01528345 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01528345 about?
NCT01528345 is a clinical study titled "Trial Evaluating Dovitinib Combined With Fulvestrant, in Postmenopausal Patients With HER2- and HR+ Breast Cancer". This trial is designed to enroll postmenopausal patients with locally advanced or metastatic, HER2- and HR+ breast cancer not amenable to curative treatment by surgery or radiotherapy, and whose disease has progressed on or after prior endocrine therapy. Patients must undergo molecular pre-screenin...
What is the current status of trial NCT01528345?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 97 participants. The study started on 2012-04. Estimated completion is 2015-04.
What interventions are being tested in trial NCT01528345?
The interventions under investigation include: Fulvestrant (DRUG), Dovitinib (DRUG), Dovitinib Placebo (DRUG).
Who is sponsoring clinical trial NCT01528345?
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 NCT01528345's enrollment target sits among peer trials
97 746th of 2000 higher than 1,254 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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