Study of Efficacy and Safety of LEE011 in Postmenopausal Women With Advanced Breast Cancer
(MONALEESA-2 Trial)

Recruiting in Palo Alto (17 mi)

+289 other locations

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Novartis Pharmaceuticals

Pivotal Trial (Near Approval)

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

The primary purpose of this study was to assess the efficacy of ribociclib, as measured by progression free survival (PFS), in postmenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who received no prior treatment for advanced disease.

Research Team

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

The patient had advanced cancer and had not received any prior systemic anti-cancer therapies.

The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.

Women with breast cancer that has spread and cannot be cured with current treatments.

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Exclusion Criteria

Patient who received any CDK4/6 inhibitor.

Patient who received any prior systemic anti-cancer therapy (including hormonal therapy and chemotherapy) for advanced breast cancer Note: Patients who received (neo) adjuvant therapy for breast cancer are eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval must be greater than 12 months from the completion of treatment until randomization. Patients who received ≤ 14 days of letrozole or anastrozole for advanced disease prior to randomization are eligible. Any prior (neo) adjuvant anti-cancer therapy must be stopped at least 5 half-lives or 7 days, whichever is longer, before randomization.

You are currently receiving treatment for another type of cancer.

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Treatment Details

Interventions

LEE011 (CDK4/6 Inhibitor)
Letrozole (Aromatase Inhibitor)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Ribociclib+ letrozoleExperimental Treatment2 Interventions

Ribociclib 600 mg daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral

Group II: Placebo + letrozolePlacebo Group2 Interventions

Placebo daily oral (3 weeks on/ 1 week off) in combination with letrozole 2.5 mg daily oral. Participants were unblinded once the final OS analysis was completed and after the implementation of protocol amendment 10 (30-Apr-21) and were given the option to crossover to treatment with ribociclib + letrozole