CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 2 enrolled
Drug / intervention
Aromatase Inhibitor +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03477396
NCT03477396Phase 2Completed

A Phase IIA Trial Assessing the Tolerability of Ribociclib in Combination With an Aromatase Inhibitor in Patients Aged 70 and Older With Hormone Receptor Positive Metastatic Breast Cancer

City of Hope Medical Center·interventional·Posted Mar 26, 2018·Updated Feb 20, 2024

In Brief

A Phase 2 clinical trial evaluating Aromatase Inhibitor, Laboratory Biomarker Analysis, and 3 other interventions for Estrogen Receptor and/or Progesterone Receptor Positive and 2 related conditions. Completed, enrolled 2 participants across 9 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 2CompletedFinished
201820192020202120222023202420252026
First PostedMar 26, 2018
Enrollment StartJun 14, 2018
Primary CompletionSep 29, 2021
Study CompletionJun 5, 2023
TodayJul 2, 2026
Enrollment to primary: 3.3 yearsPosted 8.3 years ago

Interventions

Aromatase Inhibitordrug

Aromatase inhibitor per treating investigator's discretion

Laboratory Biomarker Analysisother

Correlative studies

Pharmacokinetic Studyother

Correlative studies

Questionnaire Administrationother

Ancillary studies

Ribociclibdrug

Given PO