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NCT03573648 · ClinicalTrials.gov registry record · Phase 2
Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer
A Phase 2 study of Breast Cancer, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- Active
- Registry status
- Phase 2
- Development phase
- 33
- Enrollment target
- 4
- Study locations
NCT03573648 is a Phase 2 study of Breast Cancer that is active but no longer recruiting, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins. The registered enrollment target is 33 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 4 study locations across 4 states.
The verdict
NCT03573648, a Phase 2 study of Breast Cancer, is active but no longer recruiting, sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 33 participants
- Enrollment target
- 4
- Study locations
Study Summary
Eligible patients with estrogen receptor positive breast cancer will undergo a biopsy and be randomized to receive endocrine therapy (ET) versus endocrine therapy with palbociclib (PET) in a 1:2 ratio. After 1 cycle (28 days) another biopsy will be obtained, and both arms will receive avelumab (A) for 3 additional cycles. Patients will then undergo breast surgery.
Conditions Studied
Interventions
- DRUG Palbociclib
- DRUG Endocrine therapy
- DRUG Avelumab
Study Locations (4)
Alabama
- University of Alabama at Birmingham - Birmingham
District of Columbia
- Sibley Memorial Hospital - Washington D.C.
Maryland
- Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins - Baltimore
Pennsylvania
- Allegheny Health Network - Pittsburgh
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2018-11-13 |
| Est. Completion | 2026-12-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03573648
The ClinicalTrials.gov registry entry for NCT03573648 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The listed sponsor is Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which Palbociclib is the first listed.
NCT03573648 reports 4 study locations spanning 4 distinct geographic areas - top geographies include Alabama, District of Columbia, Maryland.
Frequently Asked Questions
What is clinical trial NCT03573648 about?
NCT03573648 is a clinical study titled "Neoadjuvant Endocrine Therapy, Palbociclib, Avelumab in Estrogen Receptor Positive Breast Cancer". Eligible patients with estrogen receptor positive breast cancer will undergo a biopsy and be randomized to receive endocrine therapy (ET) versus endocrine therapy with palbociclib (PET) in a 1:2 ratio. After 1 cycle (28 days) another biopsy will be obtained, and both arms will receive avelumab (A) f...
What is the current status of trial NCT03573648?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 33 participants. The study started on 2018-11-13. Estimated completion is 2026-12-30.
What conditions does trial NCT03573648 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03573648?
The interventions under investigation include: Palbociclib (DRUG), Endocrine therapy (DRUG), Avelumab (DRUG).
Who is sponsoring clinical trial NCT03573648?
This trial is sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, which has 523 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03573648 being conducted?
This trial has 4 study locations across Alabama, District of Columbia, Maryland, Pennsylvania. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Related
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