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NCT03477396 · ClinicalTrials.gov registry record · Phase 2
Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer
A Phase 2 study of HER2/Neu Negative and Stage IV Breast Cancer AJCC v6 and v7, sponsored by City of Hope Medical Center.
- Completed
- Registry status
- Phase 2
- Development phase
- 2
- Enrollment target
- 9
- Study locations
NCT03477396: Completed Phase 2 study of HER2/Neu Negative and Stage IV Breast Cancer AJCC v6 and v7, sponsored by City of Hope Medical Center.
NCT03477396 is a Phase 2 study of HER2/Neu Negative and Stage IV Breast Cancer AJCC v6 and v7 that has completed, run by City of Hope Medical Center. The registered enrollment target is 2 participants, below the 167-participant average among 28 other HER2/Neu Negative trials with a reported enrollment target (99% lower). The trial reports 9 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03477396, a Phase 2 study of HER2/Neu Negative and Stage IV Breast Cancer AJCC v6 and v7, has completed, sponsored by City of Hope Medical Center.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 2 participants
- Enrollment target
- 9
- Study locations
Study Summary
This phase IIA trial studies the side effects of ribociclib and aromatase inhibitor and how well they work in treating participants with hormone receptor positive breast cancer that has spread to other places in the body. Ribociclib and aromatase inhibitors may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
Primary Outcome
Number of participants with grade 2 and above toxicities attributed (possible, probable or definite) to ribociclib
Conditions Studied
Interventions
- OTHER Laboratory Biomarker Analysis
- OTHER Questionnaire Administration
- DRUG Ribociclib
- OTHER Pharmacokinetic Study
- DRUG Aromatase Inhibitor
Study Locations (9)
California
- City of Hope Corona - Corona
- City of Hope Medical Center - Duarte
- City of Hope Antelope Valley - Lancaster
- City of Hope Mission Hills - Mission Hills
- City of Hope Rancho Cucamonga - Rancho Cucamonga
- City of Hope South Pasadena - South Pasadena
- City of Hope West Covina - West Covina
New York
- Roswell Park Cancer Institute - Buffalo
- Wilmot Cancer Institute - Rochester
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2018-06-14 |
| Est. Completion | 2023-06-05 |
| Phase | Phase 2 |
What the finished NCT03477396 record still lists
NCT03477396 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 2 participants, a relatively small participant target, below the 167-participant average among 28 other HER2/Neu Negative trials with a reported enrollment target (99% lower).
The record links to 3 conditions, with HER2/Neu Negative appearing as the primary indexed condition, and to 5 interventions - of which Laboratory Biomarker Analysis is the first listed.
NCT03477396 lists 9 locations in 2 states (California, New York).
Frequently Asked Questions
What is clinical trial NCT03477396 about?
NCT03477396 is a clinical study titled "Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer". This phase IIA trial studies the side effects of ribociclib and aromatase inhibitor and how well they work in treating participants with hormone receptor positive breast cancer that has spread to other places in the body. Ribociclib and aromatase inhibitors may stop the growth of tumor cells by bloc...
What is the current status of trial NCT03477396?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 2 participants. The study started on 2018-06-14. Estimated completion is 2023-06-05.
What conditions does trial NCT03477396 study?
This clinical trial studies the following conditions: HER2/Neu Negative, Stage IV Breast Cancer AJCC v6 and v7, Estrogen Receptor and/or Progesterone Receptor Positive.
What interventions are being tested in trial NCT03477396?
The interventions under investigation include: Laboratory Biomarker Analysis (OTHER), Questionnaire Administration (OTHER), Ribociclib (DRUG), Pharmacokinetic Study (OTHER), Aromatase Inhibitor (DRUG).
Who is sponsoring clinical trial NCT03477396?
This trial is sponsored by City of Hope Medical Center, which has 582 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03477396 being conducted?
This trial has 9 study locations across California, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for HER2/Neu Negative
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03477396's enrollment target sits among peer trials
2 29th of 28 the lowest of 28 other HER2/Neu Negative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other HER2/Neu Negative 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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