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Estrogen Receptor Antagonist

Ribociclib for Breast Cancer (MONALEESA-3 Trial)

Phase 3
Waitlist Available
Research Sponsored by Novartis Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patient is an adult male/female ≥ 18 years old at the time of informed consent and has signed informed consent before any trial related activities and according to local guidelines. Female patients must be postmenopausal.
Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory and has HER2-negative breast cancer.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, every 8 weeks after randomization during 18 months, then every 12 weeks up to end of treatment; end of treatment; and every 8 or 12 weeks post-treatment until progression (post-treatment efficacy visits), assessed up to approximately 26 months
Awards & highlights

MONALEESA-3 Trial Summary

This trial is testing a new cancer drug combo to see if it's effective and safe for people with hormone-positive, HER2-negative breast cancer who've had little to no prior treatment.

Eligible Conditions
  • Breast Cancer

MONALEESA-3 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

MONALEESA-3 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, every 8 weeks after randomization during 18 months, then every 12 weeks up to end of treatment; end of treatment; and every 8 or 12 weeks post-treatment until progression (post-treatment efficacy visits), assessed up to approximately 26 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, every 8 weeks after randomization during 18 months, then every 12 weeks up to end of treatment; end of treatment; and every 8 or 12 weeks post-treatment until progression (post-treatment efficacy visits), assessed up to approximately 26 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
Progression Free Survival (PFS) Per Investigator Assessment
Secondary outcome measures
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Clinical Benefit Rate (CBR) Per Investigator Assessment
Duration of Response (DOR) Per Investigator Assessment
+8 more

MONALEESA-3 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ribociclib + fulvestrantExperimental Treatment2 Interventions
Ribociclib was administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. For participants who did not tolerate the protocol-specified dosing schedule, dose adjustments were permitted in order to allow the patient to continue the study treatment.
Group II: Placebo + fulvestrantPlacebo Group2 Interventions
Placebo was administered orally for 21 consecutive days within a 28-day cycle. This treatment was combined with fulvestrant, which was administered via intramuscular injections of 500mg every 28 days starting on Day 1 of each cycle. Additionally, an extra dose of fulvestrant was given on Day 15 of Cycle 1. For participants who did not tolerate the protocol-specified dosing schedule, dose adjustments were permitted in order to allow the patient to continue the study treatment. Participants were unblinded after the implementation of protocol amendment 4 (29-Jan-20) and were given the option to crossover to treatment with ribociclib and fulvestrant.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fulvestrant
2011
Completed Phase 3
~3700
Ribociclib
2018
Completed Phase 3
~2330

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,196,722 Total Patients Enrolled
88 Trials studying Breast Cancer
37,889 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.

By how many people is this trial being organized?

"To make participation more accessible, this trial is running at 40 locations. If you choose to enroll, the site selection tool can help you find the centre that is closest to your home."

Answered by AI

How many individuals are a part of this test group?

"Recruitment for this study is not currently underway. However, the clinical trial was first posted on 6/9/2015 and last edited on 11/10/2022. If you are interested in alternative studies, 2373 trials for patients with breast cancer and 185 trials for those taking Ribociclib are enrolling at this time."

Answered by AI

Are there any volunteers needed for this research project?

"The clinicaltrials.gov website reveals that this study isn't currently looking for new participants. Although, this could change in the future as the trial was most recently updated on November 10th, 2022. Additionally, there are 2558 other trials that are actively recruiting patients."

Answered by AI

Are there any similar studies that have been conducted with Ribociclib?

"As of right now, there are 185 ongoing clinical trials researching the use of Ribociclib. This includes 38 Phase 3 trials. Additionally, although many trials for Ribociclib are based in Shanghai, China, there are a total of 7574 locations running these sorts of tests."

Answered by AI

Could you please list any negative side effects associated with Ribociclib?

"This medication has received a safety rating of 3. This is due to the fact that it is a Phase 3 trial, meaning that there is both efficacy data as well as multiple rounds of safety data supporting its use."

Answered by AI

For what purpose is Ribociclib most often prescribed?

"Ribociclib is frequently used to target malignant neoplasms. Additionally, this medication can be employed to fight pik3ca gene mutation, progression, disease, and prior endocrine therapy."

Answered by AI
Recent research and studies
~74 spots leftby Mar 2025