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AzTrials

Advanced Metastatic Breast CancerPhase 3MONALEESA-7NCT02278120

Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

A Phase 3 study testing Ribociclib, Tamoxifen and Letrozole in people with Advanced Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 183 sites in 30 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+)… Read more about this study

Who is it for?
Ages 18 to 59 years, women only
Conditions the study is for
Advanced Metastatic Breast Cancer
What is being tested?
Ribociclib, Tamoxifen and Letrozole
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
672 participants
Where
183 sitesin 30 countries
Study dates
20 Nov 2014to 20 Apr 2023
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 59 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients had advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
  • 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

Who cannot join

  • Patients who had received a prior CDK4/6 inhibitor
  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

183 sites in 30 countries.

183 sites in 30 countries

United States35 sites

  • University of New Mexico Hospital SC-2

    Albuquerque, New Mexico, 87106

  • University of Michigan Comprehensive Cancer Center Onc Dept

    Ann Arbor, Michigan, 48109

  • Comprehensive Blood and Cancer SC-2

    Bakersfield, California, 93309

  • Sidney Kimmel CCC At JH Dept of Onc.

    Baltimore, Maryland, 21231

  • Massachusetts General Hospital Onc Dept

    Boston, Massachusetts, 02114

  • Erlanger Medical Center SC

    Chattanooga, Tennessee, 37403

  • University of Chicago SC-3

    Chicago, Illinois, 60637

  • Danbury Hospital SC

    Danbury, Connecticut, 06810

  • Comprehensive Cancer Center at Saint Joseph Hospital SC

    Denver, Colorado, 80218

  • Duke Univ Medical Center Duke (SC)

    Durham, North Carolina, 27710

  • Providence Regional Cancer Partnership

    Everett, Washington, 98201

  • Florida Cancer Specialists Onc Dept

    Fort Myers, Florida, 33901

  • Florida Cancer Specialists SC-2

    Fort Myers, Florida, 33901

  • The Center for Cancer and Blood Disorders SC

    Fort Worth, Texas, 76104

  • Bon Secours Cancer Center SC

    Greenville, South Carolina, 29607

  • Penn State University Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Memorial Cancer Institute SC

    Hollywood, Florida, 33021

  • Moanalua Medical Center. Attn: Oncology Dept SC

    Honolulu, Hawaii, 96817

  • Methodist Hospita Methodist Can Cen Dept of Oncology

    Houston, Texas, 77030

  • Uni of TX MD Anderson Cancer Cntr SC-5

    Houston, Texas, 77030

  • Kadlec Clinic Hematology and Onco Kadlec Clinic Hematology & Onc

    Kennewick, Washington, 99336

  • Clinical Research Alliance .

    Lake Success, New York, 11042

  • University Of California Los Angeles Dept of Onc

    Los Angeles, California, 90095

  • Norton Cancer Institute SC

    Louisville, Kentucky, 40202

  • University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3

    Madison, Wisconsin, 53792-6164

  • NorthWest Georgia Oncology Centers IRB

    Marietta, Georgia, 30060

  • University Of Miami Univ Miami 2

    Miami, Florida, 33136

  • Bon Secours Virginia Health System

    Midlothian, Virginia, 23114

  • SCRI Oncology Partners Tennessee Oncology (3)

    Nashville, Tennessee, 37203

  • Meridian Health Systems SC

    Neptune City, New Jersey, 07754

  • Northern Utah Cancer Associates

    Ogden, Utah, 84403-3105

  • Mays Cancer Ctr Uthsa Mdacc SC-4

    San Antonio, Texas, 78229

  • Brooke Army Medical Center SC

    San Antonio, Texas, 78234

  • Washington Uni School of Med SC

    St Louis, Missouri, 63110

  • Northwest Medical Specialties Dept of Onc

    Tacoma, Washington, 98405

Other trials in United States

Italy20 sites

  • Novartis Investigative Site

    Benevento, BN, 82100

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Candiolo, TO, 10060

  • Novartis Investigative Site

    Catania, CT, 95124

  • Novartis Investigative Site

    Cona, FE, 44100

  • Novartis Investigative Site

    Cremona, CR, 26100

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    L’Aquila, AQ, 67100

  • Novartis Investigative Site

    Lecce, LE, 73100

  • Novartis Investigative Site

    Lucca, LU, 55100

  • Novartis Investigative Site

    Meldola, FC, 47014

  • Novartis Investigative Site

    Milan, MI, 20141

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Perugia, PG, 06129

  • Novartis Investigative Site

    Prato, PO, 59100

  • Novartis Investigative Site

    Province of Macerata, MC, 62100

  • Novartis Investigative Site

    Roma, RM, 00168

  • Novartis Investigative Site

    Terni, TR, 05100

  • Novartis Investigative Site

    Udine, UD, 33100

Other trials in Italy

Spain17 sites

  • Novartis Investigative Site

    Alcorcón, Madrid, 28922

  • Novartis Investigative Site

    Almería, Andalusia, 04009

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Barakaldo, Vizcaya, 48903

  • Novartis Investigative Site

    Barcelona, Catalonia, 08003

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Donostia / San Sebastian, Basque Country, 20080

  • Novartis Investigative Site

    Elche, Alicante, 03203

  • Novartis Investigative Site

    Madrid, 28033

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Mallorca, Balearic Islands, 07198

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

  • Novartis Investigative Site

    Sant Joan Despí, Barcelona, 08970

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Valencia, Valencia, 46010

Other trials in Spain

Germany12 sites

  • Novartis Investigative Site

    Bonn, 53111

  • Novartis Investigative Site

    Dresden, 01307

  • Novartis Investigative Site

    Erlangen, 91054

  • Novartis Investigative Site

    Essen, 45136

  • Novartis Investigative Site

    Esslingen am Neckar, 73730

  • Novartis Investigative Site

    Kiel, 24105

  • Novartis Investigative Site

    Leipzig, 04103

  • Novartis Investigative Site

    Mühlhausen, 99974

  • Novartis Investigative Site

    München, 81377

  • Novartis Investigative Site

    Offenbach, 63069

  • Novartis Investigative Site

    Ravensburg, 88214

  • Novartis Investigative Site

    Ulm, 89081

Other trials in Germany

France8 sites

  • Novartis Investigative Site

    Caen, 14021

  • Novartis Investigative Site

    Lille, 59020

  • Novartis Investigative Site

    Lyon, 69373

  • Novartis Investigative Site

    Montpellier, 34298

  • Novartis Investigative Site

    Paris, 75015

  • Novartis Investigative Site

    Rouen, 76038

  • Novartis Investigative Site

    Strasbourg, 67000

  • Novartis Investigative Site

    Toulouse, 31059

Other trials in France

Taiwan8 sites

  • Novartis Investigative Site

    Changhua, 50006

  • Novartis Investigative Site

    Kaohsiung City, 83301

  • Novartis Investigative Site

    New Taipei City, 23561

  • Novartis Investigative Site

    Taipei, 10002

  • Novartis Investigative Site

    Taipei, 103616

  • Novartis Investigative Site

    Taipei, 10449

  • Novartis Investigative Site

    Taipei, 11217

  • Novartis Investigative Site

    Taoyuan, 33305

Other trials in Taiwan

Brazil7 sites

  • Novartis Investigative Site

    Barretos, São Paulo, 14784 400

  • Novartis Investigative Site

    Ijuí, Rio Grande do Sul, 98700-000

  • Novartis Investigative Site

    Londrina, Paraná, 86015-520

  • Novartis Investigative Site

    Passo Fundo, Rio Grande do Sul, 99010-260

  • Novartis Investigative Site

    São Paulo, São Paulo, 01317-002

  • Novartis Investigative Site

    São Paulo, São Paulo, 01509-900

  • Novartis Investigative Site

    São Paulo, São Paulo, 04014-002

Other trials in Brazil

Canada6 sites

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1Z2

  • Novartis Investigative Site

    Montreal, Quebec, H3G 1L5

  • Novartis Investigative Site

    Ottawa, Ontario, K1H 8L6

  • Novartis Investigative Site

    Québec, Quebec, G1S 4L8

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E6

Other trials in Canada

Hungary6 sites

  • Novartis Investigative Site

    Budapest, 1134

  • Novartis Investigative Site

    Budapest, H 1122

  • Novartis Investigative Site

    Budapest, H-1032

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Szeged, 6720

  • Novartis Investigative Site

    Szolnok, H-5000

Other trials in Hungary

Lebanon6 sites

  • Novartis Investigative Site

    Beirut, 10999

  • Novartis Investigative Site

    Beirut, 1107 2020

  • Novartis Investigative Site

    Beirut, 166378

  • Novartis Investigative Site

    El Achrafiyé, 166830

  • Novartis Investigative Site

    El Chouf, LBN, 1503201002

  • Novartis Investigative Site

    Saida, 652

Other trials in Lebanon

South Korea6 sites

  • Novartis Investigative Site

    Bundang Gu, Gyeonggi-do, 13620

  • Novartis Investigative Site

    Gyeonggi-do, Korea, 10408

  • Novartis Investigative Site

    Seoul, 03080

  • Novartis Investigative Site

    Seoul, 03722

  • Novartis Investigative Site

    Seoul, 05505

  • Novartis Investigative Site

    Seoul, 06351

Other trials in South Korea

Turkey (Türkiye)6 sites

  • Novartis Investigative Site

    Adana, 01160

  • Novartis Investigative Site

    Ankara, 06100

  • Novartis Investigative Site

    Diyarbakır, 21000

  • Novartis Investigative Site

    Edirne, 22030

  • Novartis Investigative Site

    Istanbul, TUR, 34098

  • Novartis Investigative Site

    Izmir, 35040

Other trials in Turkey (Türkiye)

Australia5 sites

  • Novartis Investigative Site

    Box Hill, Victoria, 3128

  • Novartis Investigative Site

    Heidelberg, Victoria, 3084

  • Novartis Investigative Site

    Murdoch, Western Australia, 6150

  • Novartis Investigative Site

    Nedlands, Western Australia, 6009

  • Novartis Investigative Site

    Waratah, New South Wales, 2298

Other trials in Australia

Portugal5 sites

  • Novartis Investigative Site

    Lisbon, 1099 023

  • Novartis Investigative Site

    Lisbon, 1400-038

  • Novartis Investigative Site

    Lisbon, 1500 650

  • Novartis Investigative Site

    Porto, 4200 319

  • Novartis Investigative Site

    Porto, 4200-072

Other trials in Portugal

Belgium4 sites

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Namur, 5000

  • Novartis Investigative Site

    Wilrijk, 2610

Other trials in Belgium

India4 sites

  • Novartis Investigative Site

    Bangalore, Karnataka, 560 095

  • Novartis Investigative Site

    Kolkata, West Bengal, 700 053

  • Novartis Investigative Site

    Mumbai, 400 012

  • Novartis Investigative Site

    Nashik, Maharashtra, 422 004

Other trials in India

Argentina3 sites

  • Novartis Investigative Site

    Córdoba, X5004FHP

  • Novartis Investigative Site

    La Rioja, 5300

  • Novartis Investigative Site

    San Salvador de Jujuy, Jujuy Province, 4600

Other trials in Argentina

Hong Kong3 sites

  • Novartis Investigative Site

    Hong Kong

  • Novartis Investigative Site

    Kowloon

  • Novartis Investigative Site

    Wan Chai

Other trials in Hong Kong

Mexico3 sites

  • Novartis Investigative Site

    León, Guanajuato, 37000

  • Novartis Investigative Site

    Metepec, Edo. de México, 01722

  • Novartis Investigative Site

    Monterrey Nuevo Leon, Monterrey, 64710

Other trials in Mexico

Bulgaria2 sites

  • Novartis Investigative Site

    Sofia, 1303

  • Novartis Investigative Site

    Varna, 9010

Other trials in Bulgaria

Colombia2 sites

  • Novartis Investigative Site

    Bogotá, 110221

  • Novartis Investigative Site

    Montería, 230004

Other trials in Colombia

Greece2 sites

  • Novartis Investigative Site

    Heraklion Crete, 711 10

  • Novartis Investigative Site

    Thessaloniki, GR, 54645

Other trials in Greece

Malaysia2 sites

  • Novartis Investigative Site

    Johor Bahru, Johor, 81100

  • Novartis Investigative Site

    Kuala Lumpur, 59100

Other trials in Malaysia

Poland2 sites

  • Novartis Investigative Site

    Gdansk, 80 952

  • Novartis Investigative Site

    Konin, 62 500

Other trials in Poland

Russia2 sites

  • Novartis Investigative Site

    Arkhangelsk, 163045

  • Novartis Investigative Site

    Saint Petersburg, 192148

Other trials in Russia

Singapore2 sites

  • Novartis Investigative Site

    Singapore, 119228

  • Novartis Investigative Site

    Singapore, 168583

Other trials in Singapore

Thailand2 sites

  • Novartis Investigative Site

    Bangkok, 10330

  • Novartis Investigative Site

    Bangkok, 10700

Other trials in Thailand

Saudi Arabia1 site

  • Novartis Investigative Site

    Riyadh, 11426

Other trials in Saudi Arabia

Switzerland1 site

  • Novartis Investigative Site

    Geneva, 1205

Other trials in Switzerland

United Arab Emirates1 site

  • Novartis Investigative Site

    Al Ain Abu Dhabi, United Arab Emirates

Other trials in United Arab Emirates

About this study

Official title: A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer

The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.

Read the detailed description

This was a randomized, Phase III, double-blind, global study comparing the treatment efficacy and safety of ribociclib + goserelin + tamoxifen or a NSAI (letrozole or anastrozole) versus placebo + goserelin + tamoxifen or a NSAI in premenopausal women with HR+, HER2- advanced breast cancer.

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.

Being tested
Ribociclib, Tamoxifen, Letrozole, Anastrozole, Goserelin
Keywords
LEE011, ribociclib, HR-positive, HER2-negative, Advanced breast cancer, Letrozole, Anastrozole, Tamoxifen, Goserelin, CDK, CDK4, CDK6, CDK4/6, Phase III, ER-positive, PR-positive, Premenopausal

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RibociclibDrug

    Also called LEE011

    Ribociclib (600 mg, in three 200 mg hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.

  • TamoxifenDrug

    Tamoxifen (20 mg, tablets) was administered orally on a continuous daily schedule (days 1-28 of each 28-day cycle)

  • LetrozoleDrug

    Letrozole (2.5 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)

  • AnastrozoleDrug

    Anastrozole (1 mg, tablets) was administered orally once daily on a continuous daily schedule (days 1-28 of each 28-day cycle)

  • GoserelinDrug

    Goserelin (3.6 mg, subcutaneous implant) was administered on day 1 of every 28-day cycle

  • PlaceboDrug

    Placebo (hard gelatin capsules) was administered orally once daily on Days 1-21 of each 28-day cycle.

Study groups in NCT02278120
Study groupRoleWhat they receive
Ribociclib + NSAI/tamoxifen + goserelinExperimentalRibociclib 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)
Receives: Drug: Ribociclib; Drug: Tamoxifen; Drug: Letrozole; Drug: Anastrozole; Drug: Goserelin
Placebo + NSAI/tamoxifen + goserelinPlacebo comparatorPlacebo 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.
Receives: Drug: Tamoxifen; Drug: Letrozole; Drug: Anastrozole; Drug: Goserelin; Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression Free Survival (PFS) by Investigator Assessment

    PFS was defined as the period starting from the date of randomization to the date of the first documented progression or death caused by any reason. In cases where patients did not experience an event, the PFS was censored at the date of the last adequate tumor assessment. Clinical deterioration without objective radiological evidence was not considered as documented disease progression. PFS was assessed via local radiology assessment according to RECIST 1.1. As per protocol, the final PFS analysis was conducted after approximately 392 PFS events were documented. The Kaplan-Meier method was used to estimate PFS, and the median PFS, along with 95% confidence intervals, was reported for each treatment group. A stratified Cox regression model was used to estimate the hazard ratio of PFS, along with 95% confidence interval

    Measured: From randomization to first documented progression or death, assessed up to approximately 29 months

Secondary outcomes (8)

  1. Overall Survival (OS)

    OS was defined as the time from the date of randomization to the date of death from any cause. In cases where the patient's death was not recorded, the OS value was censored at the date of the last known patient's survival status. OS was estimated using the Kaplan-Meier method. As per protocol, the final OS analysis was conducted after approximately 189 deaths were documented.

    The median OS, along with 95% confidence intervals, was reported for each treatment group.The distribution of OS between the two treatment arms was compared using a log-rank test at one-sided cumulative 2.5% level of significance. A stratified Cox regression was used to estimate the OS hazard ratio and the associated 95% CI.

    Measured: From randomization to death, assessed up to approximately 45 months

  2. Overall Response Rate (ORR) by Investigator Assessment

    ORR is the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 as per local assessment. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 29 months

  3. Clinical Benefit Rate (CBR) by Investigator Assessment

    Percentage of participants with complete response (CR) or partial response (PR) or stable disease (SD) lasting 24 weeks or longer as defined in RECIST 1.1 and local assessment. CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters; SD = Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease: PD = At least a 20% increase in the sum of diameter of all measured target lesions, taking as reference the smallest sum of diameter of all target lesions recorded at or after baseline. In addition to the relative increase of 20% the sum must also demonstrate an absolute increase of at least 5 mm.

    Measured: Up to approximately 29 months

  4. Time to Response (TTR) by Investigator Assessment

    Time to response is the time from the date of randomization to the first documented response (CR or PR, which must be confirmed subsequently) according to RECIST 1.1 as per local assessment. The Kaplan-Meier method was used to estimate TTR, and the median TTR, along with 95% confidence intervals, was reported for each treatment group. Participants who did not achieve a confirmed response were censored at the maximum follow-up time for patients who had a PFS event (i.e. either progressed or died due to any cause) or at the date of last adequate tumor assessment otherwise.

    CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 29 months

  5. Duration of Response (DOR) by Investigator Assessment

    DOR was defined as the time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer as defined in RECIST 1.1 per investigator assessment. The Kaplan-Meier method was used to estimate DOR, and the median DOR, along with 95% confidence intervals, was reported for each treatment group. If a participant had not had an event, duration was censored at the date of last adequate tumor assessment.

    CR = Disappearance of all non-nodal target lesions. In addition, any pathological lymph nodes assigned as target lesions must have a reduction in short axis to < 10 mm; PR = At least a 30% decrease in the sum of diameter of all target lesions, taking as reference the baseline sum of diameters.

    Measured: Up to approximately 29 months

  6. Time to Definitive Deterioration of Eastern Cooperative Oncology Group Performance Status (ECOG PS) by at Least One Category of the Score

    ECOG PS categorized patients based on their ability to perform daily activities and self-care, with scores ranging from 0 to 5. A score of 0 indicated no restrictions in activity, while higher scores indicated increasing limitations. Time to definitive deterioration was defined as the time from the date of randomization to the date of the event, defined as experiencing an increase in ECOG PS by at least one category from the baseline or death. A deterioration was considered definitive if no improvements in the ECOG PS were observed at a subsequent time. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive deterioration, along with 95% confidence intervals, was reported for each treatment group. Patients receiving any further therapy prior to definitive worsening were censored at their date of last assessment prior to start of therapy. Patients that had not worsened at the data cutoff point were censored at the date of last assessment.

    Measured: Baseline, up to approximately 29 months

  7. Time to Definitive 10% Deterioration in the Global Health Status/Quality of Life (GHS/QoL) Scale Score of the European Organization for Research and Treatment of Cancer's Core Quality of Life Questionnaire (EORTC QLQ-C30)

    The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The time to definitive 10% deterioration is defined as the time from the date of randomization to the date of event, which is defined as at least 10% relative to baseline worsening of the QoL score (without further improvement above the threshold) or death due to any cause. The Kaplan-Meier method was used to estimate the distribution, and the median time to definitive 10% deterioration, along with 95% confidence intervals, was reported for each treatment group. If a patient had not had an event, time to deterioration was censored at the date of the last adequate QoL evaluation.

    Measured: Up to approximately 29 months

  8. Change From Baseline in the GHS/QoL Scale Score of the EORTC QLQ-C30

    The EORTC QLQ-C30 is a questionnaire that includes 5 functional scales, 3 symptom scales, 1 GHS/QoL scale, and 6 single items. GHS/QoL scale score ranges between 0 and 100. A high score for GHS/QoL represents better functioning or QoL.The change from baseline in the GHS/QoL score was assessed. A positive change from baseline indicated improvement. For subjects who discontinued treatment without disease progression, post-treatment efficacy visits occurred every 8 weeks during the initial 18 months since start of treatment, followed by visits every 12 weeks until disease progression.

    Measured: Baseline, every 2 cycles after randomization during 18 months, then every 3 cycles up to end of treatment (EOT); EOT; and every 8 or 12 weeks post-treatment until progression, assessed up to approximately 29 months. Cycle=28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Oct 2014 (estimated)
  2. Study start20 Nov 2014
  3. Primary completion21 Aug 2017
  4. Study completion20 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
672 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02278120
Sponsor's protocol ID
CLEE011E2301
Other IDs
2014-001931-36, 2014
Acronym
MONALEESA-7
Status last verified
Feb 2024
First submitted
22 Oct 2014
Last updated
12 Mar 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com

Publications

  • Ji Y, Wang C, Combes FP, Ho YY, Fasching PA, Untch M, Zarate JP, Crown J. Quantitative Pharmacology Justifying Ribociclib Dose in Early Breast Cancer. Clin Pharmacokinet. 2026 Aug;65(8):1217-1228. doi: 10.1007/s40262-026-01643-3. Epub 2026 Jun 23.

    PubMed 42334791

  • 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.

    PubMed 39826197

  • 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.

    PubMed 37673211

  • 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.

    PubMed 36800111

  • 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.

    PubMed 34965945

  • 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.

    PubMed 34504990

  • 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.

    PubMed 34158598

  • 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.

    PubMed 33769862

  • 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.

    PubMed 31305131

  • 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.

    PubMed 31166679

  • 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.

    PubMed 29804902

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ribociclib, Tamoxifen and Letrozole in people with Advanced Metastatic Breast Cancer, run by Novartis Pharmaceuticals at 183 sites in 30 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 183 sites in United States, Italy, Spain, Germany, France and 25 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Feb 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) by Investigator Assessment (time frame: From randomization to first documented progression or death, assessed up to approximately 29 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02278120, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.

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