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NCT01560416 · ClinicalTrials.gov registry record · Phase 2
Fulvestrant With or Without Ganetespib in HR+ Breast Cancer
A Phase 2 study, sponsored by Dana-Farber Cancer Institute.
- Completed
- Registry status
- Phase 2
- Development phase
- 50
- Enrollment target
NCT01560416: Completed Phase 2 study, sponsored by Dana-Farber Cancer Institute.
NCT01560416 is a Phase 2 study that has completed, run by Dana-Farber Cancer Institute. The registered enrollment target is 50 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01560416, a Phase 2 study, has completed, sponsored by Dana-Farber Cancer Institute.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 50 participants
- Enrollment target
Study Summary
Ganetespib is a drug that may stop cancer cells from growing. This drug has been used in other research studies and laboratory experiments. It has also been studied in phase I trials, where the appropriate dosing has been determined. Ganetespib is considered an "HSP90 inhibitor". By blocking HSP90, ganetespib is thought to reduce the ability of cancer cells to become resistant to treatment. Fulvestrant is a hormonal therapy that works by attaching to estrogen receptors. In doing so, it can block the effect of estrogen on cancer cells. In addition, fulvestrant causes a decrease in the number of estrogen receptors. Fulvestrant is a drug that is approved by the FDA for treatment of metastatic, hormone receptor positive breast cancer, based upon the results of phase III clinical trials. In the laboratory, adding ganetespib to fulvestrant appears to improve its effectiveness. It is not known whether this is true in humans. In this research study, we are evaluating the effect of the addition of ganetespib to fulvestrant in participants with hormone receptor-positive, metastatic breast cancer.
Primary Outcome
PFS based on Kaplan-Meier is defined as the time from study entry to the earliest documentation of disease progression (PD) or death. Participants alive without evidence of PD are censored at the date of last disease assessment. Participants who receive non-protocol anti-cancer therapy before disease progression are censored at time of last disease assessment.
Interventions
- DRUG Fulvestrant
- DRUG Ganetespib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 50 participants |
| Start Date | 2012-06 |
| Est. Completion | 2016-06-26 |
| Phase | Phase 2 |
What the finished NCT01560416 record still lists
NCT01560416 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 50 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (62% lower).
The record links to 0 conditions, and to 2 interventions - of which Fulvestrant is the first listed.
NCT01560416 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01560416 about?
NCT01560416 is a clinical study titled "Fulvestrant With or Without Ganetespib in HR+ Breast Cancer". Ganetespib is a drug that may stop cancer cells from growing. This drug has been used in other research studies and laboratory experiments. It has also been studied in phase I trials, where the appropriate dosing has been determined. Ganetespib is considered an "HSP90 inhibitor". By blocking HSP90, ...
What is the current status of trial NCT01560416?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 50 participants. The study started on 2012-06. Estimated completion is 2016-06-26.
What interventions are being tested in trial NCT01560416?
The interventions under investigation include: Fulvestrant (DRUG), Ganetespib (DRUG).
Who is sponsoring clinical trial NCT01560416?
This trial is sponsored by Dana-Farber Cancer Institute, which has 781 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01560416's enrollment target sits among peer trials
50 1195th of 2000 higher than 740 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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