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NCT02692755 · ClinicalTrials.gov registry record · Phase 2
Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer
A Phase 2 study, sponsored by Georgetown University.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT02692755: Completed Phase 2 study, sponsored by Georgetown University.
NCT02692755 is a Phase 2 study that has completed, run by Georgetown University. The registered enrollment target is 35 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02692755, a Phase 2 study, has completed, sponsored by Georgetown University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer. Hematological safety is a composite endpoint of episodes of febrile neutropenia and treatment discontinuation due to neutropenia according to current recommendations for management of neutropenia
Primary Outcome
For study purpose febrile neutropenia will be defined according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) v4.0: "ANC less than 1000/mm3 with a single temperature of \>38.3 degrees Celsius (101 degrees Fahrenheit) or a sustained temperature of 38 degrees Celsius (100.4 degrees Fahrenheit) for more than one hour." Planned oncology therapy is defined as completion of one year of therapy for advanced breast cancer in the absence of disease progres
Interventions
- DRUG Palbociclib + Letrozole or Fulvestrant
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2016-09 |
| Est. Completion | 2021-03-23 |
| Phase | Phase 2 |
What the finished NCT02692755 record still lists
NCT02692755 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 35 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (74% lower).
The record links to 0 conditions, and to 1 intervention - of which Palbociclib + Letrozole or Fulvestrant is the first listed.
NCT02692755 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02692755 about?
NCT02692755 is a clinical study titled "Palbociclib / Letrozole or Fulvestrant in African American Women With HR+ HER2- Breast Cancer". This study aims to evaluate the hematological safety of palbociclib with letrozole and fulvestrant in African American women with hormone receptor positive HER2 negative advanced breast cancer. Hematological safety is a composite endpoint of episodes of febrile neutropenia and treatment discontinuat...
What is the current status of trial NCT02692755?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2016-09. Estimated completion is 2021-03-23.
What interventions are being tested in trial NCT02692755?
The interventions under investigation include: Palbociclib + Letrozole or Fulvestrant (DRUG).
Who is sponsoring clinical trial NCT02692755?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02692755's enrollment target sits among peer trials
35 1524th of 2000 higher than 462 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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