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Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer (MONALEESA-7)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02278120
Recruitment Status : Active, not recruiting
First Posted : October 29, 2014
Results First Posted : February 26, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:

This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer.

The purpose of this study is to assess the efficacy of Ribociclib (LEE011), as measured by progression free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast cancer


Condition or disease Intervention/treatment Phase
Advanced Metastatic Breast Cancer Drug: LEE011 Drug: Tamoxifen Drug: Letrozole Drug: Anastrozole Drug: Goserelin Drug: LEE011 Placebo Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 672 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : November 20, 2014
Actual Primary Completion Date : August 21, 2017
Estimated Study Completion Date : December 21, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Ribociclib (LEE011) + NSAI/tamoxifen + goserelin
LEE011 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)
Drug: LEE011
LEE011 600 mg daily oral

Drug: Tamoxifen
tamoxifen 20 mg daily oral

Drug: Letrozole
letrozole 2.5 mg daily oral

Drug: Anastrozole
anastrozole 1 mg daily oral

Drug: Goserelin
Goserelin 3.6 mg subcutaneous injection

Placebo Comparator: LEE011 placebo+NSAI/tamoxifen+goserelin
LEE011 Placebo 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)
Drug: Tamoxifen
tamoxifen 20 mg daily oral

Drug: Letrozole
letrozole 2.5 mg daily oral

Drug: Anastrozole
anastrozole 1 mg daily oral

Drug: Goserelin
Goserelin 3.6 mg subcutaneous injection

Drug: LEE011 Placebo
LEE011 placebo 600 mg daily oral




Primary Outcome Measures :
  1. Progression Free Survival (PFS) Per Investigator's Assessment [ Time Frame: Up to approximatley 25 months ]
    PFS, defined as the time from the date of randomization to the date of the first documented progression or death due to any cause and assessed according to Response Evaluation Criteria In Solid Tumors (RECIST) v1.1]. PFS was assessed via a local radiology assessment according to RECIST 1.1


Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to approximately 69 months ]
    Time from date of randomization to the date of death from any cause

  2. Overall Response Rate (ORR) Per Local Assessment [ Time Frame: Up to approximately 25 months ]
    ORR is the percentage of participants with the best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1. 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.

  3. Clinical Benefit Rate (CBR) [ Time Frame: Up to approximately 25 months ]
    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.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.

  4. Safety and Tolerability of LEE011 [ Time Frame: Up to approximately 26 months ]
    Safety and tolerability will be determined by type, frequency and severity of adverse events and laboratory abnormalities per Common Terminology Criteria for Adverse Events (CTCAE) version 4.03

  5. Time to Response (TTR) Per Local Investigator's Assessment [ Time Frame: Up to approximately 25 months ]
    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. All patients will be included in time to response calculations. Patients who do not achieve a confirmed response will be censored at the maximum follow-up time (i.e. first patient first visit to last patient last visit used for the analysis) 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.

  6. Duration of Response (DOR) Per Investigator's Assessment - Patients With Confirmed Complete Response (CR) or Partial Response (PR) [ Time Frame: Up to approximately 25 months ]
    Time from the first documented response (CR or PR) to the first documented progression or death due to underlying cancer

  7. Time to Definitive Deterioration of the ECOG PS From Baseline [ Time Frame: Baseline, up to approximately 25 months ]
    Time to deterioration of Eastern Cooperative Oncology Group (ECOG) Performance Status (PS)

  8. Time to 10% Deterioration in the Global Health Status/QOL Scale Score of the EORTC QLQ-C30 [ Time Frame: Up to approximately 25 months ]
    Patient reported outcomes for health related quality of life

  9. Change From Baseline in the Global Health Status/QOL Scale Score of the EORTC QLQ-C30 [ Time Frame: Up to approximately 25 months ]
    Patient reported outcomes for health related quality of life



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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
  • Patient is premenopausal or perimenopausal at the time of study entry
  • Patients who received (neo) adjuvant therapy for breast cancer are eligible
  • Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
  • Patient has HER2-negative breast cancer
  • Patient must have either measurable disease or If no measurable disease is present, then at least one predominantly lytic bone lesion
  • Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  • Patient has adequate bone marrow and organ function

Exclusion Criteria:

  • Patient who has received a prior CDK4/6 inhibitor
  • Patient is postmenopausal
  • Patients who currently have inflammatory breast cancer at screening.
  • Patients who 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.
  • Patient has 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.
  • Patient with CNS metastases.
  • Patient has active cardiac disease or a history of cardiac dysfunction
  • Patient is currently using other antineoplastic agents
  • Patient is pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception

Other protocol-defined Inclusion/Exclusion may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02278120


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Locations
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United States, California
Comprehensive Blood and Cancer Center SC-2
Bakersfield, California, United States, 93309
City of Hope National Medical Center SC-5
Duarte, California, United States, 91010 3000
University of California San Diego - Moores Cancer Center Onc Dep
La Jolla, California, United States, 92093-0658
University of California at Los Angeles Dept of Onc
Los Angeles, California, United States, 90095
Stanford University Medical Center SC
Palo Alto, California, United States, 94304-1509
Sansum Clinic SC
Santa Barbara, California, United States, 93105
United States, Colorado
Comprehensive Cancer Center at Saint Joseph Hospital SC
Denver, Colorado, United States, 80218
United States, Connecticut
Danbury Hospital SC
Danbury, Connecticut, United States, 06810
United States, Florida
Florida Cancer Specialists Onc Dept
Fort Myers, Florida, United States, 33901
Florida Cancer Specialists SC-2
Fort Myers, Florida, United States, 33901
Memorial Cancer Institute SC
Hollywood, Florida, United States, 33021
University of Miami Univ Miami 2
Miami, Florida, United States, 33136
Sacred Heart Medical Oncology SC
Pensacola, Florida, United States, 32504
United States, Georgia
NorthWest Georgia Oncology Centers NW Georgia Oncology
Marietta, Georgia, United States, 30060
United States, Hawaii
Moanalua Medical Center. Attn: Oncology Dept SC
Honolulu, Hawaii, United States, 96817
United States, Illinois
University of Chicago SC-3
Chicago, Illinois, United States, 60637
United States, Kansas
University of Kansas Hospital and Medical Center Medical Pavilion
Kansas City, Kansas, United States, 66160
United States, Kentucky
Norton Cancer Institute SC
Louisville, Kentucky, United States, 40202
United States, Maryland
Sidney Kimmel Comprehensive Cancer Center Johns Hopkins Med Dept of Onc.
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Massachusetts General Hospital Onc Dept
Boston, Massachusetts, United States, 02114
United States, Michigan
University of Michigan Comprehensive Cancer Center Onc Dept
Ann Arbor, Michigan, United States, 48109
United States, Missouri
Washington University School of Medicine SC
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Meridian Health Systems SC
Neptune, New Jersey, United States, 07754
United States, New Mexico
University of New Mexico Hospital SC-2
Albuquerque, New Mexico, United States, 87106
United States, New York
Clinical Research Alliance
Lake Success, New York, United States, 11042
United States, North Carolina
Duke University Medical Center Duke (SC)
Durham, North Carolina, United States, 27710
United States, Pennsylvania
Penn State University Milton S Hershey Medical Center
Hershey, Pennsylvania, United States, 17033
United States, South Carolina
Bon Secours Cancer Center SC
Greenville, South Carolina, United States, 29607
United States, Tennessee
Erlanger Medical Center SC
Chattanooga, Tennessee, United States, 37403
Tennessee Oncology Tennessee Oncology (3)
Nashville, Tennessee, United States, 37203
United States, Texas
The Center for Cancer and Blood Disorders SC
Fort Worth, Texas, United States, 76104
Methodist Hospital / Methodist Cancer Center Dept of Oncology
Houston, Texas, United States, 77030
University of Texas MD Anderson Cancer Center SC-5
Houston, Texas, United States, 77030
Millennium Oncology SC
Houston, Texas, United States, 77090
Cancer Therapy and Research Center UT Health Science Center SC-4
San Antonio, Texas, United States, 78229
Brooke Army Medical Center SC
San Antonio, Texas, United States, 78234
United States, Utah
Northern Utah Cancer Associates
Ogden, Utah, United States, 84403-3105
United States, Virginia
Bon Secours Virginia Health System
Midlothian, Virginia, United States, 23114
United States, Washington
Providence Regional Cancer Partnership
Everett, Washington, United States, 98201
Kadlec Clinic Hematology and Oncology Kadlec Clinic Hematology & Onc
Kennewick, Washington, United States, 99336
Northwest Medical Specialties Dept of Onc
Tacoma, Washington, United States, 98405
United States, Wisconsin
University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 3
Madison, Wisconsin, United States, 53792-6164
Argentina
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Cordoba, Argentina, X5004FHP
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Jujuy, Argentina, 4600
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La Rioja, Argentina, 5300
Australia, New South Wales
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Waratah, New South Wales, Australia, 2298
Australia, Victoria
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Box Hill, Victoria, Australia, 3128
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Heidelberg, Victoria, Australia, 3084
Australia, Western Australia
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Murdoch, Western Australia, Australia, 6150
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Nedlands, Western Australia, Australia, 6009
Belgium
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Bruxelles, Belgium, 1000
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Leuven, Belgium, 3000
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Namur, Belgium, 5000
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Wilrijk, Belgium, 2610
Brazil
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Londrina, PR, Brazil, 86015-520
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Ljui, Rio Grande Do Sul, Brazil, 98700
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Passo Fundo, RS, Brazil, 99010-260
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Barretos, SP, Brazil, 14784 400
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Sao Jose do Rio Preto, SP, Brazil, 15090 000
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Sao Paulo, SP, Brazil, 01317-002
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Sao Paulo, SP, Brazil, 03102-002
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São Paulo, SP, Brazil, 01509-900
Bulgaria
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Sofia, Bulgaria, 1303
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Varna, Bulgaria, 9002
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Varna, Bulgaria, 9010
Canada, Alberta
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Edmonton, Alberta, Canada, T6G 1Z2
Canada, British Columbia
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Vancouver, British Columbia, Canada, V5Z 4E6
Canada, Ontario
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Ottawa, Ontario, Canada, K1H 8L6
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Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
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Montréal, Quebec, Canada, H3G 1L5
Canada
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Quebec, Canada, G1S 4L8
Colombia
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Bogota, Colombia
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Monteria, Colombia
France
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Strasbourg Cedex, Cedex, France, 67091
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Caen Cedex, France, 14021
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Lille Cedex, France, 59020
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Lyon Cedex, France, 69373
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Montpellier Cedex 5, France, 34298
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Paris, France, 75015
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Rouen Cedex 1, France, 76038
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Toulouse, France, 31059
Germany
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Muehlhausen, Thueringen, Germany, 99974
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Bonn, Germany, 53111
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Dresden, Germany, 01307
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Erlangen, Germany, 91054
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Essen, Germany, 45136
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Esslingen, Germany, 73730
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Kiel, Germany, 24105
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Leipzig, Germany, 04103
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Muenchen, Germany, 81377
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Offenbach, Germany, 63069
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Ravensburg, Germany, 88214
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Rostock, Germany, 18059
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Ulm, Germany, 89081
Greece
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Thessaloniki, GR, Greece, 54645
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Heraklion Crete, Greece, 711 10
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Patras, Greece, 265 00
Hong Kong
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Hong Kong, Hong Kong
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Kowloon, Hong Kong
Hungary
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Budapest, Hungary, 1134
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Budapest, Hungary, H 1122
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Budapest, Hungary, H-1032
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Debrecen, Hungary, 4032
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Szeged, Hungary, 6720
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Szolnok, Hungary, H-5000
India
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Bangalore, Karnataka, India, 560 095
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Nashik, Maharashtra, India, 422 004
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Kolkatta, West Bengal, India, 700 053
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Mumbai, India, 400 012
Italy
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L'Aquila, AQ, Italy, 67100
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Benevento, BN, Italy, 82100
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Bologna, BO, Italy, 40138
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Cremona, CR, Italy, 26100
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Catania, CT, Italy, 95124
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Meldola, FC, Italy, 47014
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Cona, FE, Italy, 44100
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Genova, GE, Italy, 16132
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Lecce, LE, Italy, 73100
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Lucca, LU, Italy, 55100
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Monza, MB, Italy, 20900
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Macerata, MC, Italy, 62100
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Milano, MI, Italy, 20141
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Palermo, PA, Italy, 90146
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Perugia, PG, Italy, 06129
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Prato, PO, Italy, 59100
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Pavia, PV, Italy, 27100
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Roma, RM, Italy, 00168
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Candiolo, TO, Italy, 10060
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Terni, TR, Italy, 05100
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Udine, UD, Italy, 33100
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Napoli, Italy, 80131
Korea, Republic of
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Bundang Gu, Gyeonggi Do, Korea, Republic of, 13620
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Gyeonggi do, Korea, Korea, Republic of, 10408
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Seoul, Korea, Korea, Republic of, 05505
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Seoul, Korea, Korea, Republic of, 06351
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Seoul, Korea, Republic of, 03080
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Seoul, Korea, Republic of, 03722
Lebanon
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El Chouf, LBN, Lebanon, 1503201002
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Ashrafieh, Lebanon, 166830
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Beirut, Lebanon, 1107 2020
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Beirut, Lebanon, 166378
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Beirut, Lebanon
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Saida, Lebanon, 652
Malaysia
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Johor Bahru, Johor, Malaysia, 81100
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Kuala Lumpur, Malaysia, 59100
Mexico
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Torreón, Coahuila, Mexico, 27000
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Mexico D.F, D.f., Mexico, 03100
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Mexico D F, Distrito Federal, Mexico, 06760
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Metepec, Edo. De México, Mexico, 01722
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Leon, Guanajuato, Mexico, 37000
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Monterrey Nuevo Leon, Monterrey, Mexico, 64710
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Cancun, Quintana Roo, Mexico, 77505
Poland
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Gdansk, Poland, 80 952
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Konin, Poland, 62 500
Portugal
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Lisboa, Portugal, 1099 023
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Lisboa, Portugal, 1400-038
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Lisboa, Portugal, 1500 650
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Porto, Portugal, 4200 319
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Porto, Portugal, 4200-072
Russian Federation
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Arkhangelsk, Russian Federation, 163045
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Saint Petersburg, Russian Federation, 192148
Saudi Arabia
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Jeddah, Saudi Arabia, 21423
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Riyadh, Saudi Arabia, 11211
Novartis Investigative Site
Riyadh, Saudi Arabia, 11426
Singapore
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Singapore, Singapore, 119228
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Singapore, Singapore, 169610
Spain
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Elche, Alicante, Spain, 03203
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Almeria, Andalucia, Spain, 04009
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Malaga, Andalucia, Spain, 29010
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Sabadell, Barcelona, Spain, 08208
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Sant Joan Despi, Barcelona, Spain, 08970
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Badalona, Catalunya, Spain, 08916
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Barcelona, Catalunya, Spain, 08003
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Barcelona, Catalunya, Spain, 08035
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Manresa, Catalunya, Spain, 08240
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Valencia, Comunidad Valenciana, Spain, 46010
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Santiago de Compostela, Galicia, Spain, 15706
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Mallorca, Islas Baleares, Spain, 07198
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Alcorcon, Madrid, Spain, 28922
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San Sebastian, Pais Vasco, Spain, 20080
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Baracaldo, Vizcaya, Spain, 48903
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Madrid, Spain, 28033
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Madrid, Spain, 28034
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Madrid, Spain, 28040
Switzerland
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Geneve, Switzerland, 1211
Taiwan
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New Taipei City, TWN, Taiwan, 23561
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Changhua, Taiwan, 50006
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Kaohsiung City, Taiwan, 83301
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Taipei, Taiwan, 10002
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Taipei, Taiwan, 10449
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Taipei, Taiwan, 11217
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Taipei, Taiwan
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Taoyuan, Taiwan, 33305
Thailand
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Bangkok, Thailand, 10330
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Bangkok, Thailand, 10700
Turkey
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Istanbul, TUR, Turkey, 34098
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Adana, Turkey, 01160
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Ankara, Turkey, 06100
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Diyarbakir, Turkey, 21000
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Edirne, Turkey, 22030
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Izmir, Turkey, 35040
United Arab Emirates
Novartis Investigative Site
Al Ain Abu Dhabi, United Arab Emirates
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Statistical Analysis Plan  [PDF] September 27, 2017
Study Protocol  [PDF] February 24, 2017


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02278120     History of Changes
Other Study ID Numbers: CLEE011E2301
2014-001931-36 ( EudraCT Number )
First Posted: October 29, 2014    Key Record Dates
Results First Posted: February 26, 2019
Last Update Posted: November 13, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

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


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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
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
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Letrozole
Anastrozole
Goserelin
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents