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CDK 4/6 Inhibitor

Ribociclib for Breast Cancer

Phase 1 & 2
Waitlist Available
Led By Sara Tolaney, MD MPH
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up disease was evaluated radiologically at baseline and each cycle on treatment; treatment continued until disease progression or unacceptable toxicity. median treatment duration was 10.9 months with range 2.5 - 19.3 months.
Awards & highlights

Study Summary

This study is evaluating whether a drug called Ribociclib can be used to treat breast cancer that has spread to other parts of the body.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~disease was evaluated radiologically at baseline and each cycle on treatment; treatment continued until disease progression or unacceptable toxicity. median treatment duration was 10.9 months with range 2.5 - 19.3 months.
This trial's timeline: 3 weeks for screening, Varies for treatment, and disease was evaluated radiologically at baseline and each cycle on treatment; treatment continued until disease progression or unacceptable toxicity. median treatment duration was 10.9 months with range 2.5 - 19.3 months. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Cohort A: Recommended Phase2 Dose (RP2D)
Cohort B: Clinical Benefit Rate (CBR)
Cohort C: Clinical Benefit Rate (CBR)
Secondary outcome measures
Cohort A: Frequency of Biomarkers
Cohort A: Incidence of Grade 3 Treatment-Related Toxicity
Cohort A: Median Progression-Free Survival (PFS)
+12 more

Trial Design

3Treatment groups
Experimental Treatment
Group I: Cohort C: Ribociclib + Trastuzumab + Fulvestrant [Phase 1b/2 Study]Experimental Treatment3 Interventions
Ribociclib will be given orally once a day continuously for a 28-day cycle of treatment (except at Dose Level -1, when Ribociclib is given Days 1-21 of a 28 day cycle). Trastuzumab will be given as IV infusions over a pre-determined period of time and dose. Fulvestrant will be dosed approximately every 28 days as per standard of care.
Group II: Cohort B: Ribociclib + Trastuzumab [Phase 1b/2 Study]Experimental Treatment2 Interventions
Ribociclib will be given orally once day (400 mg per day on a continuous schedule) for a 21-day cycle of treatment. Trastuzumab will be given as IV infusions over 6 mg/kg every 3 weeks.
Group III: Cohort A: Ribociclib + T-DM1 [3+3 Design]Experimental Treatment2 Interventions
Ribociclib will be given orally once day (day 5-18) at a pre-determine dose for two weeks of a 21 day cycle. During dose escalation, patients received doses of ribociclib of Period 1: 300 mg (n = 3), Period 2: 400 mg (n = 3), Period 3: 500 mg (n = 3), and Period 4: 600 mg (n = 3). Maximum dose-escalation of Ribociclib will be up to 600 mg. Dose-escalation will stop if DLT exceed limit. T-DM1 will be given as IV infusions on Day 1 of a 3 week cycle at a pre-determined dose over pre-determined period of time.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
2018
Completed Phase 3
~2330
Fulvestrant
2011
Completed Phase 3
~3690
T-DM1
2014
Completed Phase 2
~450
Trastuzumab
2014
Completed Phase 4
~5190

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,923 Total Patients Enrolled
141 Trials studying Breast Cancer
22,592 Patients Enrolled for Breast Cancer
NovartisIndustry Sponsor
1,611 Previous Clinical Trials
2,721,010 Total Patients Enrolled
56 Trials studying Breast Cancer
21,163 Patients Enrolled for Breast Cancer
Sara Tolaney, MD MPHPrincipal InvestigatorDana-Farber Cancer Institute
3 Previous Clinical Trials
167 Total Patients Enrolled
3 Trials studying Breast Cancer
167 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.
Sara Tolaney 2016. "An Open-Label, Phase Ib/II Clinical Trial Of Cdk 4/6 Inhibitor, Ribociclib (Lee011), In Combination With Trastuzumab Or T-Dm1 For Advanced/Metastatic Her2-Positive Breast Cancer.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02657343.
~3 spots leftby Apr 2025
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