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Study of Efficacy and Safety of LEE011 in Men and Postmenopausal Women With Advanced Breast Cancer.

NCT ID: NCT02422615

Last Updated: 2023-11-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

726 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-06-09

Study Completion Date

2023-01-11

Brief Summary

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The main aim of this study was to evaluate the efficacy and safety of adding ribociclib to fulvestrant in men and postmenopausal women with hormone receptor positive (HR+), HER2-negative advanced breast cancer.

Detailed Description

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This study was a randomized, phase III, double-blind, placebo-controlled international trial aimed at determining the efficacy and safety of treatment with fulvestrant in combination with ribociclib compared to fulvestrant with placebo in men and postmenopausal women diagnosed with HR+, HER2-negative advanced breast cancer. The study comprised four phases: screening (up to 28 days), randomized treatment, post-treatment disease progression follow-up, and post-treatment survival follow-up.

Enrolled participants were randomly assigned to receive either fulvestrant+ribociclib or fulvestrant+placebo in a ratio of 2:1. The randomization process was stratified based on the presence of liver and/or lung metastases (yes versus no) and prior endocrine therapy. Treatment was administered until disease progression, occurrence of unacceptable toxicity, or discontinuation from the study treatment for other reasons.

Participants who discontinued treatment due to reasons other than disease progression or withdrawal of consent for efficacy follow-up continued to be monitored until disease progression, death, withdrawal of consent, loss to follow-up, or subject/guardian decision.

All participants who discontinued treatment were followed for survival until the predetermined number of overall survival (OS) events was reached.

A protocol amendment 4 (dated 29-Jan-2020) allowed for unblinding of study participants, and those still receiving placebo had the option to switch to the ribociclib arm. The decision for crossover was made at the investigator's discretion and required patient consent.

Conditions

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Advanced Breast Cancer

Keywords

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HR-positive HER2-negative Advanced breast cancer LEE011 ribociclib fulvestrant faslodex CDK CDK4 CDK6 CDK4/6 CDK4/6 inhibitor Phase III ER-positive PR-positive Postmenopausal Men Breast Neoplasms Breast Diseases Neoplasms Neoplasms by Site Antineoplastic Agents Antineoplastic Agents, Hormonal Estrogen Receptor Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Therapeutic Use

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Following protocol amendment 4 (29-Jan-2020), study participants were unblinded, with an opportunity for those patients still in the study in the arm of placebo + fulvestrant to transition to the treatment of ribociclib + fulvestrant.
Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ribociclib + fulvestrant

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 Type EXPERIMENTAL

Ribociclib

Intervention Type DRUG

Ribociclib capsules were administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle.

Fulvestrant

Intervention Type DRUG

Fulvestrant was administered via intramuscular injections at a dose of 500mg every 28 days, starting on Day 1 of each cycle. In Cycle 1, an additional dose of Fulvestrant was given on Day 15.

Placebo + fulvestrant

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.

Group Type PLACEBO_COMPARATOR

Fulvestrant

Intervention Type DRUG

Fulvestrant was administered via intramuscular injections at a dose of 500mg every 28 days, starting on Day 1 of each cycle. In Cycle 1, an additional dose of Fulvestrant was given on Day 15.

Placebo

Intervention Type DRUG

Placebo capsules were administered orally for 21 consecutive days within a 28-day cycle.

Interventions

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Ribociclib

Ribociclib capsules were administered orally at a daily dose of 600mg for 21 consecutive days within a 28-day cycle.

Intervention Type DRUG

Fulvestrant

Fulvestrant was administered via intramuscular injections at a dose of 500mg every 28 days, starting on Day 1 of each cycle. In Cycle 1, an additional dose of Fulvestrant was given on Day 15.

Intervention Type DRUG

Placebo

Placebo capsules were administered orally for 21 consecutive days within a 28-day cycle.

Intervention Type DRUG

Other Intervention Names

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LEE011

Eligibility Criteria

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Inclusion Criteria

1. Patients were adults, both male and female, aged ≥ 18 years at the time of providing informed consent. Female patients were required to be postmenopausal. Informed consent was obtained prior to any trial-related activities, following local guidelines.
2. Patients had a confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer, determined through histological and/or cytological examination by a local laboratory. Patients also had HER2-negative breast cancer.
3. Patients had either measurable disease as per RECIST 1.1 criteria or at least one predominantly lytic bone lesion.
4. Patients had advanced breast cancer, which included locoregionally recurrent disease not amenable to curative therapies (such as surgery or radiotherapy) or metastatic breast cancer. Patients fell into one of the following categories:

* Newly diagnosed with advanced/metastatic breast cancer and treatment-naïve.
* Relapsed with documented evidence of relapse more than 12 months after completing (neo)adjuvant endocrine therapy, without any prior treatment for advanced/metastatic disease.
* Relapsed with documented evidence of relapse on or within 12 months from completing (neo)adjuvant endocrine therapy, without any prior treatment for advanced/metastatic disease.
* Relapsed with documented evidence of relapse more than 12 months after completing adjuvant endocrine therapy and subsequently progressed after receiving one line of endocrine therapy (antiestrogen or aromatase inhibitor) for advanced/metastatic disease.
* Newly diagnosed with advanced/metastatic breast cancer at diagnosis and progressed after receiving one line of endocrine therapy (antiestrogen or aromatase inhibitor), with documented evidence of progression.
5. Patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
6. Patients had adequate bone marrow and organ function.

Exclusion Criteria

Patients with symptomatic visceral disease or disease burden that rendered them ineligible for endocrine therapy, based on the investigator's judgment.

2\. Patients who had received prior treatment with chemotherapy (except for neoadjuvant/adjuvant chemotherapy), fulvestrant, or any CDK4/6 inhibitor.

3\. Patients with inflammatory breast cancer at the screening stage. 4. Patients with central nervous system (CNS) involvement, unless they were at least 4 weeks from completing prior therapy before initiating the study treatment and had a stable CNS tumor at the time of screening. They were also required not to be receiving steroids and/or enzyme-inducing anti-epileptic medications for brain metastases.

5\. Patients with clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.

6\. Patients who were currently receiving any of the following substances, which could not be discontinued 7 days prior to initiating treatment:

* Known strong inducers or inhibitors of CYP3A4/5.
* Substances with a known risk of prolonging the QT interval or inducing Torsades de Pointes.
* Substances with a narrow therapeutic window and predominantly metabolized through CYP3A4/5.
* Herbal preparations/medications, dietary supplements.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Southern Cancer Center PC SC-2

Mobile, Alabama, United States

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Ironwood Cancer and Research Centers SC-2

Chandler, Arizona, United States

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Highlands Oncology Group .

Fayetteville, Arkansas, United States

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UCLA Medical Center .

Los Angeles, California, United States

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Central Coast Medical Oncology Corporation SC

Santa Maria, California, United States

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St Joseph Heritage Healthcare

Santa Rosa, California, United States

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Poudre Valley Hospital

Fort Collins, Colorado, United States

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Florida Cancer Research Institute Dept of Oncology

Davie, Florida, United States

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Florida Hospital Cancer Institute SC

Orlando, Florida, United States

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UF Health Cancer Center at Orlando Health

Orlando, Florida, United States

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John D Archbold Memorial Hospital Main

Thomasville, Georgia, United States

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Moanalua Medical Center. Attn: Oncology Dept SC

Honolulu, Hawaii, United States

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Oncology Specialists, SC Advocate Medical Group-Niles

Park Ridge, Illinois, United States

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Jackson Oncology Associates SC

Jackson, Mississippi, United States

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Meridian Health Systems Regulatory

Neptune City, New Jersey, United States

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University of New Mexico Cancer Center SC

Albuquerque, New Mexico, United States

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CR Wood Cancer Center SC

Glens Falls, New York, United States

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Clinical Research Alliance .

Lake Success, New York, United States

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NYU Langone Med Center CV Research NYU Langone Medical Center

New York, New York, United States

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Genesis Cancer Services SC

Zanesville, Ohio, United States

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Penn State University Milton S Hershey Medical Center SC

Hershey, Pennsylvania, United States

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Millennium Research Clin Develop SC

Houston, Texas, United States

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Northern Utah Cancer Associates CFTY720DUS01

Ogden, Utah, United States

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Providence Regional Cancer Partnership .

Everett, Washington, United States

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Providence Regional Cancer System SC

Lacey, Washington, United States

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Virginia Mason Medical Center-Oncology SC

Seattle, Washington, United States

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Novartis Investigative Site

St Leonards, New South Wales, Australia

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Herston, Queensland, Australia

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East Melbourne, Victoria, Australia

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Nedlands, Western Australia, Australia

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Innsbruck, Tyrol, Austria

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Vienna, , Austria

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Vienna, , Austria

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Aalst, , Belgium

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Charleroi, , Belgium

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Hasselt, , Belgium

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Leuven, , Belgium

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Liège, , Belgium

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Namur, , Belgium

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Sofia, , Bulgaria

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Surrey, British Columbia, Canada

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Vancouver, British Columbia, Canada

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Victoria, British Columbia, Canada

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Moncton, New Brunswick, Canada

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Halifax, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Kingston, Ontario, Canada

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Newmarket, Ontario, Canada

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Montreal, Quebec, Canada

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Rimouski, Quebec, Canada

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Sherbrooke, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Bogotá, , Colombia

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Montería, , Colombia

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Brno Bohunice, Czech Republic, Czechia

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Liberec, Czech Republic, Czechia

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Brno, , Czechia

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Prague, , Czechia

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Prague, , Czechia

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Aalborg, , Denmark

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Aarhus, , Denmark

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Copenhagen, , Denmark

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Herlev, , Denmark

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Odense C, , Denmark

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Vejle, , Denmark

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Strasbourg, Cedex, France

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Saint-Cloud, Hauts De Seine, France

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Reims, Marne, France

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Besançon, , France

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Bordeaux, , France

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Bordeaux, , France

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Brest, , France

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Créteil, , France

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Le Mans, , France

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Lille, , France

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Limoges, , France

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Paris, , France

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Pierre-Bénite, , France

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Toulon La Seyne Sur Mer, , France

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Langen, Hesse, Germany

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Georgsmarienhütte, Lower Saxony, Germany

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Augsburg, , Germany

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Berlin, , Germany

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Berlin, , Germany

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Bielefeld, , Germany

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Bonn, , Germany

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Cologne, , Germany

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Dresden, , Germany

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Erlangen, , Germany

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Fürth, , Germany

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Hamburg, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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Heidelberg, , Germany

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Lübeck, , Germany

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Mühlhausen, , Germany

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München, , Germany

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Oldenburg, , Germany

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Ravensburg, , Germany

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Saarbrücken, , Germany

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Troisdorf, , Germany

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Tübingen, , Germany

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Velbert, , Germany

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Weiden, , Germany

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Budapest, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Debrecen, , Hungary

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Szolnok, , Hungary

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L’Aquila, AQ, Italy

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Brescia, BS, Italy

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Catania, CT, Italy

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Lecce, LE, Italy

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Milan, MI, Italy

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Rozzano, MI, Italy

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Pontedera, PI, Italy

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Napoli, , Italy

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Amman, , Jordan

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Beirut, , Lebanon

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El Achrafiyé, , Lebanon

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Johor Bahru, Johor, Malaysia

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Kuching, Sarawak, Malaysia

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Oaxaca City, , Mexico

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Amsterdam, , Netherlands

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Breda, , Netherlands

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Deventer, , Netherlands

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Enschede, , Netherlands

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Groningen, , Netherlands

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Hoofddorp, , Netherlands

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Maastricht, , Netherlands

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Nieuwegein, , Netherlands

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Roermond, , Netherlands

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Sittard-Geleen, , Netherlands

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The Hague, , Netherlands

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Tilburg, , Netherlands

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Oslo, , Norway

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Konin, , Poland

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Warsaw, , Poland

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Lisbon, , Portugal

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Porto, , Portugal

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Arkhangelsk, , Russia

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Tambov, , Russia

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Singapore, , Singapore

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Seoul, , South Korea

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Seoul, , South Korea

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Seoul, , South Korea

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Granada, Andalusia, Spain

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Madrid, Andalusia, Spain

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Málaga, Andalusia, Spain

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Seville, Andalusia, Spain

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Sant Joan Despí, Barcelona, Spain

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Salamanca, Castille and León, Spain

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Barcelona, Catalonia, Spain

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A Coruña, Galicia, Spain

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Alcorcón, Madrid, Spain

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San Sebastián de los Reyes, Madrid, Spain

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Madrid, , Spain

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Madrid, , Spain

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Eskilstuna, , Sweden

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Sundsvall, , Sweden

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Vaxjo, , Sweden

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Aarau, , Switzerland

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Basel, , Switzerland

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Zurich, , Switzerland

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Bangkok, , Thailand

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Bangkok, , Thailand

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Istanbul, , Turkey (Türkiye)

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Izmir, , Turkey (Türkiye)

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Plymouth, Devon, United Kingdom

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Newcastle upon Tyne, , United Kingdom

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Countries

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Argentina Brazil India United States Australia Austria Belgium Bulgaria Canada Colombia Czechia Denmark France Germany Hungary Italy Jordan Lebanon Malaysia Mexico Netherlands Norway Poland Portugal Russia Singapore South Korea Spain Sweden Switzerland Thailand Turkey (Türkiye) United Kingdom

References

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Hart LL, Im SA, Tolaney SM, Campone M, Pluard T, Sousa B, Freyer G, Decker T, Kalinsky K, Sopher G, Gao M, Hu H, Kuemmel S. Efficacy, safety, and patient-reported outcomes across young to older age groups of patients with HR+/HER2- advanced breast cancer treated with ribociclib plus endocrine therapy in the randomized MONALEESA-2, -3, and -7 trials. Eur J Cancer. 2025 Feb 25;217:115225. doi: 10.1016/j.ejca.2025.115225. Epub 2025 Jan 8.

Reference Type DERIVED
PMID: 39826197 (View on PubMed)

Andre F, Su F, Solovieff N, Hortobagyi G, Chia S, Neven P, Bardia A, Tripathy D, Lu YS, Lteif A, Taran T, Babbar N, Slamon D, Arteaga CL. Pooled ctDNA analysis of MONALEESA phase III advanced breast cancer trials. Ann Oncol. 2023 Nov;34(11):1003-1014. doi: 10.1016/j.annonc.2023.08.011. Epub 2023 Sep 5.

Reference Type DERIVED
PMID: 37673211 (View on PubMed)

Neven P, Fasching PA, Chia S, Jerusalem G, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Zarate JP, Wang Y, Chakravartty A, Wang C, Slamon DJ. Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2- advanced breast cancer receiving first-line ribociclib plus fulvestrant. Breast Cancer Res. 2023 Aug 31;25(1):103. doi: 10.1186/s13058-023-01701-9.

Reference Type DERIVED
PMID: 37653397 (View on PubMed)

Ji Y, Yartsev V, Quinlan M, Serra P, Wang Y, Chakraborty A, Miller M. Justifying Ribociclib Dose in Patients with Advanced Breast Cancer with Renal Impairment Based on PK, Safety, and Efficacy Data: An Innovative Approach Integrating Data from a Dedicated Renal Impairment Study and Oncology Clinical Trials. Clin Pharmacokinet. 2023 Mar;62(3):493-504. doi: 10.1007/s40262-022-01206-2. Epub 2023 Feb 17.

Reference Type DERIVED
PMID: 36800111 (View on PubMed)

Burris HA, Chan A, Bardia A, Thaddeus Beck J, Sohn J, Neven P, Tripathy D, Im SA, Chia S, Esteva FJ, Hart L, Zarate JP, Ridolfi A, Lorenc KR, Yardley DA. Safety and impact of dose reductions on efficacy in the randomised MONALEESA-2, -3 and -7 trials in hormone receptor-positive, HER2-negative advanced breast cancer. Br J Cancer. 2021 Aug;125(5):679-686. doi: 10.1038/s41416-021-01415-9. Epub 2021 Jun 22.

Reference Type DERIVED
PMID: 34158598 (View on PubMed)

Slamon DJ, Neven P, Chia S, Jerusalem G, De Laurentiis M, Im S, Petrakova K, Valeria Bianchi G, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Ji Y, Wang C, Deore U, Chakravartty A, Zarate JP, Taran T, Fasching PA. Ribociclib plus fulvestrant for postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer in the phase III randomized MONALEESA-3 trial: updated overall survival. Ann Oncol. 2021 Aug;32(8):1015-1024. doi: 10.1016/j.annonc.2021.05.353. Epub 2021 Jun 5.

Reference Type DERIVED
PMID: 34102253 (View on PubMed)

Prat A, Chaudhury A, Solovieff N, Pare L, Martinez D, Chic N, Martinez-Saez O, Braso-Maristany F, Lteif A, Taran T, Babbar N, Su F. Correlative Biomarker Analysis of Intrinsic Subtypes and Efficacy Across the MONALEESA Phase III Studies. J Clin Oncol. 2021 May 1;39(13):1458-1467. doi: 10.1200/JCO.20.02977. Epub 2021 Mar 26.

Reference Type DERIVED
PMID: 33769862 (View on PubMed)

Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Sondhi M, Wang Y, Chakravartty A, Rodriguez-Lorenc K, Taran T, Jerusalem G. Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer. N Engl J Med. 2020 Feb 6;382(6):514-524. doi: 10.1056/NEJMoa1911149. Epub 2019 Dec 11.

Reference Type DERIVED
PMID: 31826360 (View on PubMed)

Yardley DA. MONALEESA clinical program: a review of ribociclib use in different clinical settings. Future Oncol. 2019 Aug;15(23):2673-2686. doi: 10.2217/fon-2019-0130. Epub 2019 Jul 15.

Reference Type DERIVED
PMID: 31305131 (View on PubMed)

Slamon DJ, Neven P, Chia S, Fasching PA, De Laurentiis M, Im SA, Petrakova K, Bianchi GV, Esteva FJ, Martin M, Nusch A, Sonke GS, De la Cruz-Merino L, Beck JT, Pivot X, Vidam G, Wang Y, Rodriguez Lorenc K, Miller M, Taran T, Jerusalem G. Phase III Randomized Study of Ribociclib and Fulvestrant in Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: MONALEESA-3. J Clin Oncol. 2018 Aug 20;36(24):2465-2472. doi: 10.1200/JCO.2018.78.9909. Epub 2018 Jun 3.

Reference Type DERIVED
PMID: 29860922 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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2015-000617-43

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CLEE011F2301

Identifier Type: -

Identifier Source: org_study_id