← Back to Search

CDK4/6 Inhibitor

Ribociclib + NSAI/tamoxifen + goserelin for Breast Cancer (MONALEESA-7 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 has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
Patients who received (neo) adjuvant therapy for breast cancer are eligible
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from randomization to death, assessed up to approximately 45 months
Awards & highlights

MONALEESA-7 Trial Summary

This trial will compare the effects of Ribociclib to placebo in premenopausal women with HR positive, HER2 negative advanced breast cancer.

Eligible Conditions
  • Breast Cancer (Metastatic)

MONALEESA-7 Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have advanced breast cancer that cannot be treated with curative intent.
Select...
You are eligible if you have not had any prior treatment for breast cancer.
Select...
Your bone marrow and organs are working properly.

MONALEESA-7 Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from randomization to death, assessed up to approximately 45 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and from randomization to death, assessed up to approximately 45 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) by Investigator Assessment
Secondary outcome measures
Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30
Clinical Benefit Rate (CBR) by Investigator Assessment
Duration of Response (DOR) by Investigator Assessment
+5 more

MONALEESA-7 Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Ribociclib + NSAI/tamoxifen + goserelinExperimental Treatment5 Interventions
Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
Group II: Placebo + NSAI/tamoxifen + goserelinPlacebo Group5 Interventions
Placebo daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days). Participants were unblinded once the final OS analysis was conducted and after the implementation of protocol amendment 6 (16-Jul-2019) and were given the option to crossover to treatment with ribociclib +NSAI/tamoxifen + goserelin.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ribociclib
2018
Completed Phase 3
~2330
Goserelin
2008
Completed Phase 3
~7100
Tamoxifen
2005
Completed Phase 4
~29860
Letrozole
2002
Completed Phase 4
~3240
Anastrozole
2019
Completed Phase 4
~10090

Find a Location

Who is running the clinical trial?

Novartis PharmaceuticalsLead Sponsor
2,851 Previous Clinical Trials
4,196,917 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.

At present, how many individuals are enrolled in this research project?

"This particular trial is no longer enrolling patients, as the last update was on September 30th, 2022. However, there are 2368 other trials for malignant neoplasms and 301 for LEE011 that are still admitting participants."

Answered by AI

Why is LEE011 given to patients so often?

"LEE011 can be used as a treatment for stage t2b carcinoma of the prostate, ovarian cancer, and other malignant neoplasms."

Answered by AI

Are there other examples of LEE011's efficacy?

"LEE011 is being trialled in 301 studies globally, with 89 of those trials being in the final stages. Many of these tests are taking place in Shanghai, but there are 20402 clinical locations running LEE011 trials."

Answered by AI

Does this test welcome elderly participants?

"In order to meet the requirements for this study, potential patients must fall between 18 to 59 years old. There are a total 84 trials for patients under 18 and 2548 for people 65 and older."

Answered by AI

Has the Food and Drug Administration given LEE011 their seal of approval?

"LEE011 has undergone extensive safety testing and has been determined to be safe for human use."

Answered by AI
Recent research and studies
~65 spots leftby Mar 2025