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

Part of paid clinical trials in Corona, California.

Sponsor
City of Hope Medical Center
Study ID
NCT03477396
Phase
PHASE2
Status
Completed

Conditions

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

Eligibility Criteria

Sex
ALL
Age
70 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Aromatase Inhibitor — DRUG
    Aromatase inhibitor per treating investigator's discretion
  • Laboratory Biomarker Analysis — OTHER
    Correlative studies
  • Pharmacokinetic Study — OTHER
    Correlative studies
  • Questionnaire Administration — OTHER
    Ancillary studies
  • Ribociclib — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jun 14, 2018
Status verified
Feb 2024
Primary completion
Sep 29, 2021
Completion
Jun 5, 2023

Study Design

Enrollment
2 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (ribociclib, aromatase inhibitor)
    Participants receive ribociclib orally PO QD on days 1-21 and aromatase inhibitor per treating investigator's discretion. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Number of Participants With Grade 2 and Above Toxicities Attributed to Ribociclib [ Time Frame: Up to 30 days of last study drug, about 3 years and 3 months ]

Locations (9)

FacilityCityStateZIPSite coordinators
City of Hope CoronaCoronaCalifornia92879-
City of Hope Medical CenterDuarteCalifornia91010-
City of Hope Antelope ValleyLancasterCalifornia93534-
City of Hope Mission HillsMission HillsCalifornia91345-
City of Hope Rancho CucamongaRancho CucamongaCalifornia91730-
City of Hope South PasadenaSouth PasadenaCalifornia91030-
City of Hope West CovinaWest CovinaCalifornia91790-
Roswell Park Cancer InstituteBuffaloNew York14263-
Wilmot Cancer InstituteRochesterNew York14642-

Find similar trials in Corona, CA

By research site
City of Hope Corona· Corona, CACity of Hope Medical Center· Duarte, CACity of Hope Antelope Valley· Lancaster, CACity of Hope Mission Hills· Mission Hills, CACity of Hope Rancho Cucamonga· Rancho Cucamonga, CACity of Hope South Pasadena· South Pasadena, CA

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