African American/Black for Breast Cancer

Phase-Based Progress Estimates
3
Effectiveness
3
Safety
Breast CancerRibociclib - Drug
Eligibility
18+
Female
What conditions do you have?
Select

Study Summary

This trial is looking at how well a drug works in people with different versions of a gene.

Eligible Conditions
  • Breast Cancer

Treatment Effectiveness

Effectiveness Progress

3 of 3
This is further along than 93% of similar trials

Study Objectives

1 Primary · 11 Secondary · Reporting Duration: Baseline, day 8-16 of cycle 1 and prior to cycle 2 (each cycle is 28 days)

Day 28
Change in QTc interval
Correlation between pharmacodynamic variants and toxicity
Leukopenia
Laboratory abnormalities - liver enzymes
Laboratory abnormalities - neutropenia
Day 28
Pharmacogenomics
Ribociclib area-under-the-curve (AUC)
Ribociclib pharmacokinetic properties - Maximum concentration (Cmax)
Ribociclib pharmacokinetic properties - clearance
Ribociclib pharmacokinetic properties - elimination half-life
Ribociclib pharmacokinetic properties - the time to reach Cmax (Tmax)
Day 28
Ribociclib pharmacokinetic properties - volume of distribution(vd)

Trial Safety

Safety Progress

3 of 3
This is further along than 85% of similar trials

Trial Design

2 Treatment Groups

African American/Black
1 of 2
Non-Hispanic White
1 of 2

Active Control

36 Total Participants · 2 Treatment Groups

Primary Treatment: African American/Black · No Placebo Group · Phase 4

African American/Black
Drug
ActiveComparator Group · 1 Intervention: Ribociclib · Intervention Types: Drug
Non-Hispanic White
Drug
ActiveComparator Group · 1 Intervention: Ribociclib · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: baseline, day 8-16 of cycle 1 and prior to cycle 2 (each cycle is 28 days)

Who is running the clinical trial?

Breast Cancer Research FoundationOTHER
60 Previous Clinical Trials
135,391 Total Patients Enrolled
35 Trials studying Breast Cancer
128,452 Patients Enrolled for Breast Cancer
Georgetown UniversityLead Sponsor
320 Previous Clinical Trials
120,654 Total Patients Enrolled
33 Trials studying Breast Cancer
13,103 Patients Enrolled for Breast Cancer
Medstar Health Research InstituteOTHER
173 Previous Clinical Trials
133,900 Total Patients Enrolled
6 Trials studying Breast Cancer
1,247 Patients Enrolled for Breast Cancer
Georgetown-Howard Universities Center for Clinical and Translational Science (GHUCCTS)OTHER
Sandra Swain, MDPrincipal InvestigatorGeorgetown University

Eligibility Criteria

Age 18+ · Female Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a non-Hispanic White person.\n
Each race-based cohort has a predetermined number of participants with each CYP3A5 phenotype per the sample size calculation (section 9.1).
You are 18 years old or older.
You are eligible for that cohort.\n
You have a documented estrogen receptor (ER) positive and/or progesterone receptor (PR) positive tumor
You have advanced breast cancer not amenable to curative therapy.