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NCT03007979 · ClinicalTrials.gov registry record · Phase 2
Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer
A Phase 2 study, sponsored by Washington University School of Medicine.
- Completed
- Registry status
- Phase 2
- Development phase
- 55
- Enrollment target
NCT03007979 is a Phase 2 study that has completed, run by Washington University School of Medicine. The registered enrollment target is 55 participants.
The verdict
NCT03007979, a Phase 2 study, has completed, sponsored by Washington University School of Medicine.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 55 participants
- Enrollment target
Study Summary
The investigators propose to conduct a study to test an alternative dosing schedule of palbociclib. With the current three-week on and one week off schedule, a significant number of patients develop grade 3 or higher degree of neutropenia and require dose reduction and sometimes discontinuation. This potentially compromises the efficacy of the drug. In addition, as the half-life of palbociclib is 27 hours, 1 week break with the standard 3 weeks on and 1 week off dosing schedule could potentially lead to recovery of Rb phosphorylation during the off week. Hence, the investigators propose a 5 days on and 2 days off schedule each week without any weeks off drug. Although the cumulative doses each 28-day cycle is roughly the same with this schedule compared to conventional dosing, the bone marrow is not exposed to the drug continuously for 21 days and rather gets frequent breaks from therapy. The investigators hypothesize that the 5 days on and 2 days off schedule is more tolerable with less frequent high grade neutropenia and dose interruption/reduction. In addition, this schedule also provides for a more continuous drug delivery to the patient since there is not a week's break in therapy, which could ultimately prove to be more efficacious.
Interventions
- DRUG Letrozole
- DRUG Fulvestrant
- DRUG Palbociclib
- DRUG Goserelin
- PROCEDURE Optional research biopsy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 55 participants |
| Start Date | 2017-06-15 |
| Est. Completion | 2023-03-31 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03007979
The ClinicalTrials.gov registry entry for NCT03007979 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 55 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Washington University School of Medicine, which has 1,502 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Letrozole is the first listed.
NCT03007979 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03007979 about?
NCT03007979 is a clinical study titled "Alternative Dosing Schedule of Palbociclib in Metastatic Hormone Receptor Positive Breast Cancer". The investigators propose to conduct a study to test an alternative dosing schedule of palbociclib. With the current three-week on and one week off schedule, a significant number of patients develop grade 3 or higher degree of neutropenia and require dose reduction and sometimes discontinuation. Thi...
What is the current status of trial NCT03007979?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 55 participants. The study started on 2017-06-15. Estimated completion is 2023-03-31.
What interventions are being tested in trial NCT03007979?
The interventions under investigation include: Letrozole (DRUG), Fulvestrant (DRUG), Palbociclib (DRUG), Goserelin (DRUG), Optional research biopsy (PROCEDURE).
Who is sponsoring clinical trial NCT03007979?
This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.
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