Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
NCT ID: NCT02278120
Last Updated: 2024-03-12
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
672 participants
INTERVENTIONAL
2014-11-20
2023-04-20
Brief Summary
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Detailed Description
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Eligible participants were randomized in a 1:1 ratio to either the ribociclib arm or the placebo arm. Study treatment continued until disease progression, unacceptable toxicity, death, or discontinuation for any other reason.
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 (post-treatment efficacy follow-up).
All participants who discontinued treatment were followed for survival until the predetermined number of overall survival (OS) events was reached.
Following the final OS analysis (performed when approximately 189 deaths were recorded) and with protocol amendment 6 (dated 18-Jul-2019), participants and investigators were unblinded and those participants in the placebo arm had the opportunity to cross-over to the ribociclib arm to receive ribociclib + goserelin + NSAI. Cross-over was optional and was conducted at the investigator's discretion and upon participant consent.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Ribociclib + NSAI/tamoxifen + goserelin
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)
Ribociclib
Ribociclib (600 mg, in three 200 mg hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.
Tamoxifen
Tamoxifen (20 mg, tablets) was administered orally on a continuous daily schedule (days 1-28 of each 28-day cycle)
Letrozole
Letrozole (2.5 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
Anastrozole
Anastrozole (1 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
Goserelin
Goserelin (3.6 mg, subcutaneous implant) was administered on day 1 of every 28-day cycle
Placebo + NSAI/tamoxifen + goserelin
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.
Tamoxifen
Tamoxifen (20 mg, tablets) was administered orally on a continuous daily schedule (days 1-28 of each 28-day cycle)
Letrozole
Letrozole (2.5 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
Anastrozole
Anastrozole (1 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
Goserelin
Goserelin (3.6 mg, subcutaneous implant) was administered on day 1 of every 28-day cycle
Placebo
Placebo (hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.
Interventions
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Ribociclib
Ribociclib (600 mg, in three 200 mg hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.
Tamoxifen
Tamoxifen (20 mg, tablets) was administered orally on a continuous daily schedule (days 1-28 of each 28-day cycle)
Letrozole
Letrozole (2.5 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
Anastrozole
Anastrozole (1 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)
Goserelin
Goserelin (3.6 mg, subcutaneous implant) was administered on day 1 of every 28-day cycle
Placebo
Placebo (hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients were premenopausal or perimenopausal at the time of study entry
* Patients who had received (neo) adjuvant therapy for breast cancer were eligible
* Patients had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
* Patients had HER2-negative breast cancer
* Patients must have either had measurable disease or If no measurable disease was present, then at least one predominantly lytic bone lesion
* Patients had an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Patients had adequate bone marrow and organ function
Exclusion Criteria
* Patients were postmenopausal
* Patients who currently had inflammatory breast cancer at screening.
* Patients who had received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.
* Patients had a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell skin carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
* Patients with CNS metastases.
* Patients had active cardiac disease or a history of cardiac dysfunction
* Patients were currently using other antineoplastic agents
* Patients were pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception.
18 Years
59 Years
FEMALE
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Wan Chai, , Hong Kong
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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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Szeged, , Hungary
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Szolnok, , Hungary
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Bangalore, Karnataka, India
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Nashik, Maharashtra, India
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Kolkata, West Bengal, India
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Mumbai, , India
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L’Aquila, AQ, Italy
Comprehensive Blood and Cancer SC-2
Bakersfield, California, United States
University Of California Los Angeles Dept of Onc
Los Angeles, California, United States
Comprehensive Cancer Center at Saint Joseph Hospital SC
Denver, Colorado, United States
Danbury Hospital SC
Danbury, Connecticut, United States
Florida Cancer Specialists Onc Dept
Fort Myers, Florida, United States
Florida Cancer Specialists SC-2
Fort Myers, Florida, United States
Memorial Cancer Institute SC
Hollywood, Florida, United States
University Of Miami Univ Miami 2
Miami, Florida, United States
NorthWest Georgia Oncology Centers IRB
Marietta, Georgia, United States
Moanalua Medical Center. Attn: Oncology Dept SC
Honolulu, Hawaii, United States
University of Chicago SC-3
Chicago, Illinois, United States
Norton Cancer Institute SC
Louisville, Kentucky, United States
Sidney Kimmel CCC At JH Dept of Onc.
Baltimore, Maryland, United States
Massachusetts General Hospital Onc Dept
Boston, Massachusetts, United States
University of Michigan Comprehensive Cancer Center Onc Dept
Ann Arbor, Michigan, United States
Washington Uni School of Med SC
St Louis, Missouri, United States
Meridian Health Systems SC
Neptune City, New Jersey, United States
University of New Mexico Hospital SC-2
Albuquerque, New Mexico, United States
Clinical Research Alliance .
Lake Success, New York, United States
Duke Univ Medical Center Duke (SC)
Durham, North Carolina, United States
Penn State University Milton S Hershey Medical Center
Hershey, Pennsylvania, United States
Bon Secours Cancer Center SC
Greenville, South Carolina, United States
Erlanger Medical Center SC
Chattanooga, Tennessee, United States
SCRI Oncology Partners Tennessee Oncology (3)
Nashville, Tennessee, United States
The Center for Cancer and Blood Disorders SC
Fort Worth, Texas, United States
Methodist Hospita Methodist Can Cen Dept of Oncology
Houston, Texas, United States
Uni of TX MD Anderson Cancer Cntr SC-5
Houston, Texas, United States
Mays Cancer Ctr Uthsa Mdacc SC-4
San Antonio, Texas, United States
Brooke Army Medical Center SC
San Antonio, Texas, United States
Northern Utah Cancer Associates
Ogden, Utah, United States
Bon Secours Virginia Health System
Midlothian, Virginia, United States
Providence Regional Cancer Partnership
Everett, Washington, United States
Kadlec Clinic Hematology and Onco Kadlec Clinic Hematology & Onc
Kennewick, Washington, United States
Northwest Medical Specialties Dept of Onc
Tacoma, Washington, United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3
Madison, Wisconsin, United States
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San Salvador de Jujuy, Jujuy Province, Argentina
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Córdoba, , Argentina
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La Rioja, , Argentina
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Waratah, New South Wales, Australia
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Box Hill, Victoria, Australia
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Heidelberg, Victoria, Australia
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Murdoch, Western Australia, Australia
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Nedlands, Western Australia, Australia
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Brussels, , Belgium
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Leuven, , Belgium
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Namur, , Belgium
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Wilrijk, , Belgium
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Londrina, Paraná, Brazil
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Ijuí, Rio Grande do Sul, Brazil
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Passo Fundo, Rio Grande do Sul, Brazil
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Barretos, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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São Paulo, São Paulo, Brazil
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Sofia, , Bulgaria
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Varna, , Bulgaria
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Edmonton, Alberta, Canada
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Vancouver, British Columbia, Canada
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Ottawa, Ontario, Canada
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Toronto, Ontario, Canada
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Montreal, Quebec, Canada
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Québec, Quebec, Canada
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Bogotá, , Colombia
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Montería, , Colombia
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Caen, , France
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Lille, , France
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Lyon, , France
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Montpellier, , France
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Paris, , France
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Rouen, , France
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Strasbourg, , France
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Toulouse, , France
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Bonn, , Germany
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Dresden, , Germany
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Erlangen, , Germany
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Essen, , Germany
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Esslingen am Neckar, , Germany
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Kiel, , Germany
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Leipzig, , Germany
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Mühlhausen, , Germany
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München, , Germany
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Offenbach, , Germany
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Ravensburg, , Germany
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Ulm, , Germany
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Thessaloniki, GR, Greece
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Heraklion Crete, , Greece
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Hong Kong, , Hong Kong
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Kowloon, , Hong Kong
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Benevento, BN, Italy
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Bologna, BO, Italy
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Cremona, CR, Italy
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Catania, CT, Italy
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Meldola, FC, Italy
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Cona, FE, Italy
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Genova, GE, Italy
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Lecce, LE, Italy
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Lucca, LU, Italy
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Macerata, MC, Italy
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Milan, MI, Italy
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Perugia, PG, Italy
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Prato, PO, Italy
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Pavia, PV, Italy
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Roma, RM, Italy
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Candiolo, TO, Italy
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Terni, TR, Italy
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Udine, UD, Italy
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Napoli, , Italy
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El Chouf, LBN, Lebanon
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Beirut, , Lebanon
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Beirut, , Lebanon
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Beirut, , Lebanon
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El Achrafiyé, , Lebanon
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Saida, , Lebanon
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Johor Bahru, Johor, Malaysia
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Kuala Lumpur, , Malaysia
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Metepec, Edo. de México, Mexico
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León, Guanajuato, Mexico
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Monterrey Nuevo Leon, Monterrey, Mexico
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Gdansk, , Poland
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Konin, , Poland
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Arkhangelsk, , Russia
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Saint Petersburg, , Russia
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Riyadh, , Saudi Arabia
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Singapore, , Singapore
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Singapore, , Singapore
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Bundang Gu, Gyeonggi-do, South Korea
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Gyeonggi-do, Korea, South Korea
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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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Seoul, , South Korea
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Elche, Alicante, Spain
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Almería, Andalusia, Spain
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Málaga, Andalusia, Spain
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Mallorca, Balearic Islands, Spain
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Sabadell, Barcelona, Spain
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Sant Joan Despí, Barcelona, Spain
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Donostia / San Sebastian, Basque Country, Spain
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Badalona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Santiago de Compostela, Galicia, Spain
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Alcorcón, Madrid, Spain
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Valencia, Valencia, Spain
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Barakaldo, Vizcaya, Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Geneva, , Switzerland
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Changhua, , Taiwan
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Kaohsiung City, , Taiwan
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New Taipei City, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taipei, , Taiwan
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Taoyuan District, , Taiwan
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Bangkok, , Thailand
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Bangkok, , Thailand
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Istanbul, TUR, Turkey (Türkiye)
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Adana, , Turkey (Türkiye)
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Ankara, , Turkey (Türkiye)
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Diyarbakır, , Turkey (Türkiye)
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Edirne, , Turkey (Türkiye)
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Izmir, , Turkey (Türkiye)
Novartis Investigative Site
Al Ain Abu Dhabi, United Arab Emirates, United Arab Emirates
Countries
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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.
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.
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.
Lu YS, Im SA, Colleoni M, Franke F, Bardia A, Cardoso F, Harbeck N, Hurvitz S, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, O'Regan R, Gasch C, Solovieff N, Wang C, Wang Y, Chakravartty A, Ji Y, Tripathy D. Updated Overall Survival of Ribociclib plus Endocrine Therapy versus Endocrine Therapy Alone in Pre- and Perimenopausal Patients with HR+/HER2- Advanced Breast Cancer in MONALEESA-7: A Phase III Randomized Clinical Trial. Clin Cancer Res. 2022 Mar 1;28(5):851-859. doi: 10.1158/1078-0432.CCR-21-3032.
Bardia A, Su F, Solovieff N, Im SA, Sohn J, Lee KS, Campos-Gomez S, Jung KH, Colleoni M, Vazquez RV, Franke F, Hurvitz S, Harbeck N, Chow L, Taran T, Rodriguez Lorenc K, Babbar N, Tripathy D, Lu YS. Genomic Profiling of Premenopausal HR+ and HER2- Metastatic Breast Cancer by Circulating Tumor DNA and Association of Genetic Alterations With Therapeutic Response to Endocrine Therapy and Ribociclib. JCO Precis Oncol. 2021 Sep 1;5:PO.20.00445. doi: 10.1200/PO.20.00445. eCollection 2021.
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.
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.
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.
Im SA, Lu YS, Bardia A, Harbeck N, Colleoni M, Franke F, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva-Vazquez R, Jung KH, Chakravartty A, Hughes G, Gounaris I, Rodriguez-Lorenc K, Taran T, Hurvitz S, Tripathy D. Overall Survival with Ribociclib plus Endocrine Therapy in Breast Cancer. N Engl J Med. 2019 Jul 25;381(4):307-316. doi: 10.1056/NEJMoa1903765. Epub 2019 Jun 4.
Tripathy D, Im SA, Colleoni M, Franke F, Bardia A, Harbeck N, Hurvitz SA, Chow L, Sohn J, Lee KS, Campos-Gomez S, Villanueva Vazquez R, Jung KH, Babu KG, Wheatley-Price P, De Laurentiis M, Im YH, Kuemmel S, El-Saghir N, Liu MC, Carlson G, Hughes G, Diaz-Padilla I, Germa C, Hirawat S, Lu YS. Ribociclib plus endocrine therapy for premenopausal women with hormone-receptor-positive, advanced breast cancer (MONALEESA-7): a randomised phase 3 trial. Lancet Oncol. 2018 Jul;19(7):904-915. doi: 10.1016/S1470-2045(18)30292-4. Epub 2018 May 24.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2014-001931-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLEE011E2301
Identifier Type: -
Identifier Source: org_study_id
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