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NCT02540330 · ClinicalTrials.gov registry record · Phase 2
A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant
A Phase 2 study, sponsored by Atossa Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 3
- Enrollment target
NCT02540330: Clinical Trial Phase 2 study, sponsored by Atossa Therapeutics.
NCT02540330 is a Phase 2 study that was terminated before completion, run by Atossa Therapeutics. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02540330, a Phase 2 study, was terminated before completion, sponsored by Atossa Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 3 participants
- Enrollment target
Study Summary
This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The subsequent 5 subjects of each group will receive fulvestrant by intraductal instillation. All subjects will be monitored for systemic and local adverse events during the procedure, and following the procedure until mastectomy or lumpectomy. Subjects that receive fulvestrant will undergo serial blood draws to determine fulvestrant blood concentration levels.
Primary Outcome
Number of adverse events per CTCAE v4.0 after treatment with fulvestrant by route of administration
Interventions
- DRUG Fulvestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 3 participants |
| Start Date | 2016-03 |
| Est. Completion | 2020-08-13 |
| Phase | Phase 2 |
Why NCT02540330 stopped before completion
NCT02540330 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).
The record links to 0 conditions, and to 1 intervention - of which Fulvestrant is the first listed.
NCT02540330 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02540330 about?
NCT02540330 is a clinical study titled "A Pre-Surgical PK Study of IM and Intraductally Delivered Fulvestrant". This is an open-label, non-randomized pharmacokinetic study of fulvestrant in women scheduled for mastectomy or lumpectomy. Eligible subjects will be identified with breast cancer or DCIS. The first subject of each of five groups will receive fulvestrant intramuscularly. The subsequent 5 subjects of...
What is the current status of trial NCT02540330?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2016-03. Estimated completion is 2020-08-13.
What interventions are being tested in trial NCT02540330?
The interventions under investigation include: Fulvestrant (DRUG).
Who is sponsoring clinical trial NCT02540330?
This trial is sponsored by Atossa Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02540330's enrollment target sits among peer trials
3 2001st of 2000 the lowest 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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