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NCT03691493 · ClinicalTrials.gov registry record · Phase 2
Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis
A Phase 2 study, sponsored by Emory University.
- Completed
- Registry status
- Phase 2
- Development phase
- 36
- Enrollment target
NCT03691493: Completed Phase 2 study, sponsored by Emory University.
NCT03691493 is a Phase 2 study that has completed, run by Emory University. The registered enrollment target is 36 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03691493, a Phase 2 study, has completed, sponsored by Emory University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 36 participants
- Enrollment target
Study Summary
This phase II trial studies how well radiation therapy given with standard care palbociclib and hormone therapy work in treating patients with breast cancer that has spread from one part of the body to the bone. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Palbociclib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Antihormone therapy, such as fulvestrant, letrozole, anastrozole, exemestane, or tamoxifen, may lessen the amount of estrogen made by the body. Giving radiation therapy, palbociclib, and hormone therapy may work better in treating breast cancer patients with bone metastasis.
Primary Outcome
Response rate will be estimated as the number of responders divided by the number of patients evaluated for response. Among patients who present with pain, responders will be considered those patients who have a 2 point decrease in the Brief Pain Inventory (BPI), and among those who do not present with pain (radiotherapy due to risk of unstable fracture or cord compression), responders will be considered those without development of a pathologic fracture or neurologic compromise (cord compressio
Interventions
- DRUG Anastrozole
- DRUG Letrozole
- DRUG Exemestane
- DRUG Fulvestrant
- DRUG Palbociclib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2019-02-08 |
| Est. Completion | 2022-10-13 |
| Phase | Phase 2 |
What the finished NCT03691493 record still lists
NCT03691493 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 36 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (73% lower).
The record links to 0 conditions, and to 5 interventions - of which Anastrozole is the first listed.
NCT03691493 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03691493 about?
NCT03691493 is a clinical study titled "Radiation Therapy, Palbociclib, and Hormone Therapy in Treating Breast Cancer Patients With Bone Metastasis". This phase II trial studies how well radiation therapy given with standard care palbociclib and hormone therapy work in treating patients with breast cancer that has spread from one part of the body to the bone. Radiation therapy uses high energy x-rays to kill tumor cells and shrink tumors. Palboci...
What is the current status of trial NCT03691493?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 36 participants. The study started on 2019-02-08. Estimated completion is 2022-10-13.
What interventions are being tested in trial NCT03691493?
The interventions under investigation include: Anastrozole (DRUG), Letrozole (DRUG), Exemestane (DRUG), Fulvestrant (DRUG), Palbociclib (DRUG).
Who is sponsoring clinical trial NCT03691493?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03691493's enrollment target sits among peer trials
36 1496th of 2000 higher than 477 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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