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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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

Select...

I have been treated with ribociclib for at least 6 cycles.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Percentage of participants with treatment-emergent adverse events (AES)

Secondary outcome measures

Clinical benefit rate

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

Ribociclib

2018

Completed Phase 3

~2330

Letrozole

2002

Completed Phase 4

~3240

Anastrozole

2019

Completed Phase 4

~10300

Fulvestrant

2011

Completed Phase 3

~3690

Goserelin

2008

Completed Phase 3

~4110

Tamoxifen

2005

Completed Phase 4

~30070

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor

2,859 Previous Clinical Trials

4,198,107 Total Patients Enrolled

88 Trials studying Breast Cancer

37,818 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has this remedy been subjected to federal sanction?

"On a scale of 1 to 3, our team at Power assigned this treatment an elevated safety rating due to the fact that it has passed through Phase 4 trials and is approved."

Answered by AI

How many medical institutions are currently involved in this research endeavor?

"This trial is presently being conducted across 16 sites, located in cities such as Beverly Hills, Fayetteville and Chandler. To reduce the burden of travel for enrolled patients, we recommend selecting a clinic closest to your location."

Answered by AI

Has this treatment been tested before in a clinical setting?

"Initial research for this specific treatment was conducted by Queen Mary University of London in 1994. As of now, 527 studies have been finished and 370 are actively enrolling participants, many from Beverly Hills California."

Answered by AI

Are there any remaining vacancies available in this trial for participants?

"According to clinicaltrials.gov, the medical trial is still taking on recruits - it was initially published on July 7th 2022 and recently updated November 10th 2022."

Answered by AI

What types of afflictions can this therapy be applied to?

"This therapy is seen as an effective means of treating progression, disease and malignant neoplasms associated with stage t2b carcinoma of the prostate."

Answered by AI

What is the aggregate amount of participants taking part in this investigation?

"The sponsor, Novartis Pharmaceuticals, aims to enrol 137 qualified patients in this trial. Clinical sites that are participating include Beverly Hills Cancer Center (Beverly Hills, California) and Highlands Oncology Group (Fayetteville, Arkansas)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Roll-over Study to Allow Continued Access to Ribociclib

2022. "Roll-over Study to Allow Continued Access to Ribociclib". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05161195.

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