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Aromatase Inhibitor

Ribociclib Combination Therapy for Breast Cancer

Phase 4
Recruiting
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Must have been receiving treatment with ribociclib for at least 6 cycles in the parent study
Be older than 18 years old
Must not have
Currently has unresolved toxicities for which ribociclib dosing has been interrupted in the parent study
Permanent discontinuation of ribociclib in the parent study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Pivotal Trial
Drug Has Already Been Approved

Summary

This trial will assess the long-term safety of ribociclib when used in combination with other drugs in participants who have already benefited from the treatment.

Who is the study for?
This trial is for breast cancer patients already in a Novartis study, who've seen benefits from Ribociclib and other drugs. They must have completed at least 6 cycles of treatment with Ribociclib. Those permanently off Ribociclib or with unresolved toxicities from it can't join.
What is being tested?
The study tests the long-term safety of continued use of Ribociclib combined with Letrozole, Anastrozole, Goserelin, Tamoxifen, or Fulvestrant in those benefiting from it after completing primary objectives in an earlier Novartis trial.
What are the potential side effects?
Ribociclib may cause low white blood cell counts increasing infection risk, tiredness, nausea, diarrhea and hair loss. Other drugs used alongside may add more side effects like hot flashes or joint pain.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been treated with ribociclib for at least 6 cycles.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I had to stop taking ribociclib due to side effects that haven't gone away.
Select...
I was permanently taken off ribociclib in a previous study.
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I can get and afford ribociclib where I live.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Percentage of participants with treatment-emergent adverse events (AES)
Secondary study objectives
Clinical benefit rate

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.

Trial Design

1Treatment groups
Experimental Treatment
Group I: RibociclibExperimental Treatment6 Interventions
All participants will receive ribociclib in combination with other drugs at the same dose/schedule as in the parent study.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Goserelin
2008
Completed Phase 3
~4080
Ribociclib
2018
Completed Phase 3
~2420
Letrozole
2002
Completed Phase 4
~3150
Anastrozole
2016
Completed Phase 4
~5550
Fulvestrant
2011
Completed Phase 3
~4030
Tamoxifen
2005
Completed Phase 4
~30110

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,921 Previous Clinical Trials
4,254,175 Total Patients Enrolled
88 Trials studying Breast Cancer
37,756 Patients Enrolled for Breast Cancer

Media Library

Anastrozole (Aromatase Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05161195 — Phase 4
Breast Cancer Research Study Groups: Ribociclib
Breast Cancer Clinical Trial 2023: Anastrozole Highlights & Side Effects. Trial Name: NCT05161195 — Phase 4
Anastrozole (Aromatase Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05161195 — Phase 4
~75 spots leftby Jan 2028
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