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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 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.

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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.

Conditions Studied

HER2/Neu Negative Stage IV Breast Cancer AJCC v6 and v7 Estrogen Receptor and/or Progesterone Receptor Positive

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

FieldValue
Enrollment Target 2 participants
Start Date 2018-06-14
Est. Completion 2023-06-05
Phase Phase 2

Sponsor

City of Hope Medical Center

582 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT03477396

The ClinicalTrials.gov registry entry for NCT03477396 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 2 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 167-participant average among 28 other HER2/Neu Negative trials with a reported enrollment target (99% lower). The listed sponsor is City of Hope Medical Center, which has 582 total studies on file at ClinicalTrials.gov.

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 reports 9 study locations spanning 2 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.