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Ribociclib and Aromatase Inhibitor in Treating Older Participants With Hormone Receptor Positive Metastatic Breast Cancer

NCT03477396 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2024-02-20

Study results available
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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

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

Interventions

DRUG

Aromatase Inhibitor

Aromatase inhibitor per treating investigator's discretion

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacokinetic Study

Correlative studies

OTHER

Questionnaire Administration

Ancillary studies

DRUG

Ribociclib

Given PO

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • City of Hope Medical Center

    lead OTHER

Principal Investigators

  • Mina Sedrak, MD · City of Hope Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-06-14
Primary Completion
2021-09-29
Completion
2023-06-05
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03477396 on ClinicalTrials.gov