Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With HR+ HER2- aBC
COMPLEEMENT-1
COMPLEEMENT-1: An Open-label, Multicenter, Phase IIIb Study to Assess the Safety and Efficacy of Ribociclib (LEE011) in Combination With Letrozole for the Treatment of Men and Pre/Postmenopausal Women With Hormone Receptor-positive (HR+) HER2-negative (HER2-) Advanced Breast Cancer (aBC) With no Prior Hormonal Therapy for Advanced Disease
2 other identifiers
interventional
3,246
37 countries
492
Brief Summary
The purpose of this study is to collect additional safety and efficacy data for the combination of ribociclib + letrozole in men and pre/postmenopausal women with HR+HER2- advanced breast cancer and no prior hormonal treatment for advanced disease..
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 breast-cancer
Started Nov 2016
492 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 20, 2016
CompletedFirst Posted
Study publicly available on registry
October 21, 2016
CompletedStudy Start
First participant enrolled
November 30, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 8, 2019
CompletedResults Posted
Study results publicly available
May 9, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
November 9, 2022
CompletedOctober 24, 2023
October 1, 2023
2.9 years
October 20, 2016
April 11, 2022
October 23, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of Participants With Adverse Events (AEs) and Serious AEs (SAEs) During Treatment With Ribociclib + Letrozole in the Core Phase
AEs were defined as the appearance of (or worsening of any pre-existing) undesirable sign(s), symptom(s), or medical condition(s). SAEs were defined as meeting at least 1 of the following criteria: is fatal or life-threatening, Results in persistent or significant disability/incapacity, constitutes a congenital anomaly/birth defect, is medically significant, requires inpatient hospitalization or prolongation of existing hospitalization. A SAE which caused death of the participant was considered as fatal SAE. AEs were assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Grade 1 to 5 were used to characterize the severity of the Adverse Event. Grade 1: mild; Grade 2: moderate; Grade 3: severe; Grade 4: life-threatening and Grade 5: death related to AE. A participant with multiple severity grades for an AE is only counted under the maximum grade.
From start of treatment up to 30 days after last treatment (for participants who did not enter to the Extension phase) or up to last treatment in the Core phase (for participants who entered the Extension phase), assessed up to approximately 33 months.
Secondary Outcomes (6)
Time-to-Progression (TTP) Based on Investigator's Assessment (Core Phase)
Up to approximately 33 months
Overall Response Rate (ORR) Based on Investigator's Assessment (Core Phase)
Up to approximately 33 months
Clinical Benefit Rate (CBR) Based on Investigator's Assessment (Core Phase)
Up to approximately 33 months
Change From Baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) Score (Core Phase)
On Day 1 of Cycle 1, 2, 3, 4 ,5, 6, 8, 10, 12 and after that every 3 cycles, and End of treatment, assessed up to 33 months. Cycle=28 days
Number of Participants With AEs and SAEs in the Extension Phase
From first dose of treatment in the Extension phase up to 30 days after last dose of treatment, assessed up approximately 37.6 months
- +1 more secondary outcomes
Other Outcomes (1)
Canadian Sub-study: Proteomic Analysis of Ribociclib and Letrozole Cohort Not Achieving Clinical Benefit Compared to a Cohort Sensitive to Treatment With Ribociclib and Letrozole
Screening (up to 28 days before first dose of study treatment)
Study Arms (1)
Ribociclib + letrozole+goserelin/leuprolide
EXPERIMENTALParticipants received ribociclib (orally taken, 3 weeks on/1 week off) in combination with letrozole (orally taken once daily). For men and premenopausal women, either goserelin was given as an injectable subcutaneous implant or leuprolide was given as an intramuscular injection.
Interventions
Ribociclib was centrally supplied to the investigators and administered orally once a day on days 1-21 of each 28 day cycle at a starting dose of 600 mg daily
Letrozole was procured locally and administered orally once a day on a continuous daily schedule at a dose of 2.5 mg
Goserelin was procured locally and administered in men and premenopausal women as an injectable subcutaneous implant administered on day 1 starting at Cycle 1 and then every 28 days at a dose of 3.6 mg (cycle = 28 days)
Leuprolide was procured locally and administered in men and premenopausal women as an injectable intramuscular depot administered on day 1 starting at Cycle 1 and then every 28 days at a dose of 7.5 mg (cycle= 28 days)
Eligibility Criteria
You may qualify if:
- Male or female advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy.
- In the case of women, both pre/perimenopausal and postmenopausal patients were allowed to be included in this study; menopausal status was relevant for the requirement of goserelin to be used concomitantly with ribociclib and letrozole.
- Postmenopausal status was defined either by: I).Prior bilateral oophorectomy OR ii). Age ≥ 60 OR iii). Age \< 60 and amenorrhea for 12 or more months (in the absence of chemotherapy, tamoxifen, toremifen, or ovarian suppression) and FSH and estradiol in the postmenopausal range per local normal range. If patient was taking tamoxifen or toremifene and age \< 60, then FSH and plasma estradiol levels would be in post-menopausal range per local normal range (NCCN Guidelines version 2.2017).
- Note: For women with therapy-induced amenorrhea, serial measurements of FSH and/or estradiol were needed to ensure menopausal status.
- Premenopausal status was defined as either: I).Patient had last menstrual period within the last 12 months OR ii). If on tamoxifen or toremifene within the past 14 days, plasma estradiol and FSH must be in the premenopausal range per local normal range OR iii). In case of therapy induced amenorrhea, plasma estradiol and/or FSH must be in the premenopausal range per local normal range.
- Perimenopausal status was define as neither premenopausal nor postmenopausal
- Patient had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory.
- Patient had HER2-negative breast cancer defined as a negative in situ hybridization test or an IHC status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, or SISH) test was required by local laboratory testing.
- Patient had an Eastern Cooperative Oncology Group (ECOG) performance status ≤2
- Patient had adequate bone marrow and organ function as defined by ALL of the following laboratory values (as assessed by local laboratory):
- Absolute neutrophil count ≥ 1.5 Ă— 10\^9/L
- Platelets ≥ 100 Ă— 10\^9/L
- Hemoglobin ≥ 9.0 g/dL
- Potassium, sodium, calcium corrected for serum albumin and magnesium within normal limits or corrected to within normal limits with supplements before first dose of the study medication
- INR ≤1.5
- +6 more criteria
You may not qualify if:
- Patient who received any CDK4/6 inhibitor
- Patient who received any prior systemic hormonal therapy for advanced breast cancer; no more than one prior regimen of chemotherapy for the treatment of metastatic disease was permitted. Note:
- Patients who received (neo) adjuvant therapy for breast cancer were eligible. If the prior neo (adjuvant) therapy included letrozole or anastrozole the disease free interval had to be greater than 12 months from the completion of treatment until study entry.
- Patient was concurrently using other anti-cancer therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (495)
Alaska Cancer Research and Education Center
Anchorage, Alaska, 99508, United States
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224, United States
Arizona Oncology Associates
Phoenix, Arizona, 85016, United States
Arizona Oncology Associates Arizona Oncology Assoc. (2)
Tucson, Arizona, 85745, United States
Highlands Oncology Group
Fayetteville, Arkansas, 72703, United States
Beverly Hills Cancer Center
Beverly Hills, California, 90211, United States
Pacific Shores Medical Group SC
Long Beach, California, 90813, United States
USC Norris Cancer Center
Los Angeles, California, 90033, United States
University of California Irvine UC Irvine (11)
Orange, California, 92868, United States
Ventura County Hematology and Oncology
Oxnard, California, 93030, United States
PCR Oncology
Pismo Beach, California, 93449, United States
California Pacific Medical Center Onc Dept
San Francisco, California, 94120-7999, United States
Centura Health Research Center Centura Health Research Center
Denver, Colorado, 80210, United States
Poudre Valley Hospital Poudre Valley Health System
Fort Collins, Colorado, 80528, United States
Valley View Hospital Cancer Center
Glenwood Springs, Colorado, 81601, United States
Florida Cancer Research Institute Dept of Oncology
Davie, Florida, 33328, United States
Foundation for Sickle Cell Disease Research
Hollywood, Florida, 33021, United States
Watson Clinic Center for Research 1730 Location
Lakeland, Florida, 33805, United States
Mid Florida Hematology and Onc Ctr
Orange, Florida, 32763, United States
Summit Cancer Care Summit Cancer Care (SC)
Savannah, Georgia, 31405, United States
John D Archbold Memorial Hospital John D. Archbold Mem Hosp (4)
Thomasville, Georgia, 31792, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, 83706, United States
Stroger Cook County Hospital Division of Hematology & Onc
Chicago, Illinois, 60612, United States
Joliet Oncology-Hematology Associates Presence Cancer Center
Joliet, Illinois, 60435, United States
Mid Illinois Hematology Oncology Mid Illinois Hema/Onc (3)
Normal, Illinois, 61761, United States
Alpha Med Physician Group, LLC
Tinley Park, Illinois, 60487, United States
Indian Univ Health Goshen Center forCancer SC
Goshen, Indiana, 46526, United States
Northwest Oncology
Munster, Indiana, 46321, United States
June E. Nylan Cancer Center
Sioux City, Iowa, 51101, United States
University of Kansas Medical Center University of Kansas Med Ctr 9
Kansas City, Kansas, 66160-7330, United States
Sarah Cannon at Overland Park Regional Medical Center
Overland Park, Kansas, 66209, United States
John Ochsner Heart and Vascular Institute Clinical Trials
New Orleans, Louisiana, 70121, United States
Northern Light Mercy Hospital SC
Portland, Maine, 04102, United States
Greater Baltimore Medical Center Cancer Center Greater Baltimore Medical Ctr
Baltimore, Maryland, 21204-6831, United States
Maryland Oncology Hematology P A Columbia
Rockville, Maryland, 20850, United States
Kaiser Permanente
Rockville, Maryland, 20879, United States
Medical Faculty Assc Inc Medical Faculty Assc., Inc. (2
Washington DC, Maryland, 20037, United States
Jackson Oncology Associates
Jackson, Mississippi, 39202, United States
Nebraska Hematology-Oncology, P.C.
Lincoln, Nebraska, 68506, United States
Nebraska Cancer Specialists Oncology Hematology West
Omaha, Nebraska, 68154, United States
Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)
Henderson, Nevada, 89052, United States
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, 07207, United States
Englewood Health
Englewood, New Jersey, 07631, United States
The Valley Hospital / Luckow Pavillion
Paramus, New Jersey, 07652, United States
Somerset Hematology Oncology Associates Somerset Hematolgy Onc -MI
Somerset, New Jersey, 08873, United States
New Mexico Cancer Care Alliance .
Albuquerque, New Mexico, 87106, United States
San Juan Oncology Associates
Farmington, New Mexico, 87401, United States
Clinical Research Alliance
Lake Success, New York, 11042, United States
Eastchester Center for Cancer Care
The Bronx, New York, 10469, United States
Oncology Speciialists of Charlotte
Charlotte, North Carolina, 28207, United States
Aultman Cancer Center Main Centre
Canton, Ohio, 44710, United States
The Christ Hospital Cancer Center Research Program Linder Research Center
Cincinnati, Ohio, 45219, United States
University Hospitals of Cleveland Seidman Cancer Center Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Cleveland Clinic Foundation Cleveland Clinic (5)
Cleveland, Ohio, 44195, United States
Dayton Physicians
Kettering, Ohio, 45409, United States
Oklahoma Cancer Specialists and Research Institute SC-2
Tulsa, Oklahoma, 74136, United States
Oregon Health Sciences University SC-5
Portland, Oregon, 97239, United States
McLeod Center for Cancer Treatment and Research
Florence, South Carolina, 29506, United States
Carolina Blood and Cancer Care of South Carolina
Rock Hill, South Carolina, 29732, United States
Millennium Research Clin Develop Millennium Oncology - FL
Houston, Texas, 77090, United States
Mays Cancer Ctr Uthsa Mdacc
San Antonio, Texas, 78229, United States
Hope Cancer Center of East Texas
Tyler, Texas, 75701, United States
Virginia Oncology Associates
Norfolk, Virginia, 23502, United States
PeaceHealth St Joseph Medical Center
Bellingham, Washington, 98225, United States
Providence Regional Medical Centre of Everett
Everett, Washington, 98201, United States
Kadlec Clinic Hematology and Onco
Kennewick, Washington, 99336, United States
Valley Medical Center Research Valley Medical Center
Renton, Washington, 98055, United States
Virginia Mason Medical Center-Oncology SC
Seattle, Washington, 98101, United States
Northwest Medical Specialties Dept.ofNW Med. Specialties
Tacoma, Washington, 98405, United States
Columbia St Mary s Hospital of Milwaukee St. Mary's Hospital Ozaukee
Milwaukee, Wisconsin, 53211, United States
Cheyenne Regional Medical Center Cheyenne Regional Med Ctr (3)
Cheyenne, Wyoming, 82001, United States
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CABA, Buenos Aires, C1125ABD, Argentina
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CABA, Buenos Aires, C1426ANZ, Argentina
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Rosario, Santa Fe Province, S2000KZE, Argentina
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San Miguel de TucumĂ¡n, TucumĂ¡n Province, T4000IAK, Argentina
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La Rioja, 5300, Argentina
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Innsbruck, Tyrol, 6020, Austria
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Graz, 8036, Austria
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Leoben, A 8700, Austria
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Rankweil, A-6830, Austria
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Salzburg, 5020, Austria
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Vienna, 1090, Austria
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Vienna, A 1090, Austria
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Vienna, A-1130, Austria
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Luxembourg, Luxembourg, 1210, Belgium
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Sint-Niklaas, Oost Vlaanderen, 9100, Belgium
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Bonheiden, 2820, Belgium
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Bruges, 8000, Belgium
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Brussels, 1090, Belgium
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Charleroi, 6000, Belgium
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Genk, 3600, Belgium
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Gabrovo, 5300, Bulgaria
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Sofia, 1303, Bulgaria
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Sofia, 1527, Bulgaria
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Sofia, 1606, Bulgaria
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Sofia, 1756, Bulgaria
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Calgary, Alberta, T2N 4N2, Canada
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Edmonton, Alberta, T6G 1Z2, Canada
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Kelowna, British Columbia, V1Y 5L3, Canada
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Surrey, British Columbia, V3V 1Z2, Canada
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Vancouver, British Columbia, V5Z 4E6, Canada
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Winnipeg, Manitoba, R3E 0V9, Canada
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Moncton, New Brunswick, E1C 6Z8, Canada
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Halifax, Nova Scotia, B3H 2Y9, Canada
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Barrie, Ontario, L4M 6M2, Canada
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Cambridge, Ontario, N1R 3G2, Canada
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Greater Sudbury, Ontario, P3E 5J1, Canada
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Hamilton, Ontario, L8V 5C2, Canada
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Kingston, Ontario, K7L 5P9, Canada
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Kitchener, Ontario, N2G 1G3, Canada
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London, Ontario, N6A 4G4, Canada
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Newmarket, Ontario, L3Y 2P9, Canada
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North York, Ontario, M2K1E1, Canada
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Oshawa, Ontario, L1G 2B9, Canada
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Ottawa, Ontario, KIH 7W9, Canada
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Sault Ste. Marie, Ontario, P6B 0A8, Canada
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Toronto, Ontario, M3M 0B2, Canada
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Toronto, Ontario, M4N 3M5, Canada
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Toronto, Ontario, M5B 1W8, Canada
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Greenfield Park, Quebec, J4V 2H1, Canada
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Laval, Quebec, H7M 3L9, Canada
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Montreal, Quebec, H3T 1E2, Canada
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Montreal, Quebec, H3T 1M5, Canada
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Montreal, Quebec, H4J 1C5, Canada
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Québec, Quebec, G1S 4L8, Canada
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Sherbrooke, Quebec, J1H 5N4, Canada
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Regina, Saskatchewan, S4T 7T1, Canada
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Saskatoon, Saskatchewan, S7N 4H4, Canada
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Santiago, 8420383, Chile
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Brno, Czech Republic, 656 53, Czechia
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Liberec, Czech Republic, 46063, Czechia
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Prague, Czech Republic, 180 00, Czechia
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ZlĂn, Czech Republic, 762 75, Czechia
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Hradec KrĂ¡lovĂ©, CZE, 500 05, Czechia
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Olomouc, CZE, 779 00, Czechia
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Brno, 625 00, Czechia
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ÄŒeskĂ© BudÄ›jovice, 370 87, Czechia
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Pardubice, 532 03, Czechia
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Prague, 100 34, Czechia
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Prague, 12808, Czechia
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Prague, 140 59, Czechia
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Prague, 150 00, Czechia
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Copenhagen, DK-2100, Denmark
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Vejle, 7100, Denmark
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Helsinki, 00029, Finland
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Oulu, FIN-90220, Finland
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Tampere, FIN-33521, Finland
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Nice, Alpes Maritimes, 06189, France
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Dijon, Cote D Or, 21034, France
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Limoges, Haute Vienne, 87000, France
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Saint-Cloud, Hauts De Seine, 92210, France
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Tours, Indre Et Loire, 37044, France
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Reims, Marne, 51056, France
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Albi, 81000, France
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Angers, 49055, France
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Avignon, 84082, France
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Besançon, 25030, France
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Bobigny, 93009, France
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Bordeaux, 33000, France
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Bordeaux, 33076, France
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Caen, 14021, France
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Clermont-Ferrand, 63011, France
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Colmar, 68024, France
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Corbeil-Essonnes, 91100, France
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Créteil, 94010, France
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Le Mans, 72015, France
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Lille, 59020, France
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Limoges, 87000, France
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Lyon, 69373, France
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Marseille, 13273, France
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Mont-de-Marsan, 40024, France
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Montpellier, 34070, France
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Montpellier, 34298, France
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Nancy, 54000, France
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Nantes, 44277, France
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Paris, 75012, France
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Paris, 75231, France
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Paris, 75475, France
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Paris, 75651, France
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Paris, 75970, France
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PĂ©rigueux, 24004, France
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Pierre-BĂ©nite, 69495, France
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Plerin Sur Mer, 22190, France
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Reims, 51100, France
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Rouen, 76038, France
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Saint-Herblain, 44805, France
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Strasbourg, 67010, France
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Strasbourg, 67091, France
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Toulon La Seyne Sur Mer, 83056, France
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Troyes, 10003, France
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VandÅ“uvre-lès-Nancy, 54519, France
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Ioannina, GR, 455 00, Greece
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Thessaloniki, GR, 54645, Greece
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Athens, 115 28, Greece
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Athens, GR 115 22, Greece
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Athens, GR14564, Greece
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PĂ¡trai, 265 00, Greece
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Thessaloniki, 540 07, Greece
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Pokfulam, Hong Kong, Hong Kong
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Hong Kong, Hong Kong
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Kowloon, Hong Kong
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Budapest, 1134, Hungary
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Budapest, H 1122, Hungary
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Budapest, H-1032, Hungary
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Debrecen, 4032, Hungary
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Szeged, 6725, Hungary
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Hyderabad, Andhra Pradesh, 500 034, India
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Tamil Nadu, Chennai, 600035, India
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Admedabad, Gujarat, 380060, India
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Bangalore, Karnataka, 560027, India
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Nashik, Maharashtra, 422 004, India
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Pune, Maharashtra, 411013, India
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New Delhi, National Capital Territory of Delhi, 110092, India
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Jaipur, Rajasthan, 302017, India
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Vellore, Tamil Nadu, 632 004, India
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Kolkata, West Bengal, 700160, India
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Delhi, 110 085, India
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Beersheba, 8457108, Israel
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Haifa, 3109601, Israel
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Jerusalem, 9112001, Israel
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Petah Tikva, 4941492, Israel
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Ramat Gan, 52621, Israel
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Tel Aviv, 6423906, Israel
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Alessandria, AL, 15100, Italy
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Ancona, AN, 60126, Italy
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L’Aquila, AQ, 67100, Italy
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Arezzo, AR, 52100, Italy
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Asti, AT, 14100, Italy
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Avellino, AV, 83100, Italy
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Bari, BA, 70124, Italy
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Bergamo, BG, 24127, Italy
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Treviglio, BG, 24047, Italy
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Benevento, BN, 82100, Italy
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Bologna, BO, 40138, Italy
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Bologna, BO, 40139, Italy
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Brindisi, BR, 72100, Italy
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Brescia, BS, 25123, Italy
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Brescia, BS, 25124, Italy
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Monserrato, CA, 09042, Italy
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Cuneo, CN, 12100, Italy
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Cremona, CR, 26100, Italy
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Catania, CT, 95124, Italy
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Cona, FE, 44100, Italy
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San Giovanni Rotondo, FG, 71013, Italy
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Florence, FI, 50134, Italy
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Genova, GE, 16132, Italy
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Grosseto, GR, 58100, Italy
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Lecco, LC, 23900, Italy
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Livorno, LI, 57124, Italy
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Lucca, LU, 55100, Italy
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Monza, MB, 20900, Italy
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Macerata, MC, 62100, Italy
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Messina, ME, 98158, Italy
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Taormina, ME, 98039, Italy
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Milan, MI, 20121, Italy
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Milan, MI, 20132, Italy
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Milan, MI, 20133, Italy
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Milan, MI, 20141, Italy
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Milan, MI, 20162, Italy
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Rozzano, MI, 20089, Italy
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Modena, MO, 41124, Italy
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Nuoro, NU, 08100, Italy
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Palermo, PA, 90127, Italy
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Palermo, PA, 90146, Italy
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Padua, PD, 35100, Italy
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Pisa, PI, 56126, Italy
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Aviano, PN, 33081, Italy
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Prato, PO, 59100, Italy
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Parma, PR, 43100, Italy
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Fano, PU, 61032, Italy
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Pavia, PV, 27100, Italy
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Reggio Calabria, RC, 89124, Italy
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Reggio Emilia, RE, 42123, Italy
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Roma, RM, 00128, Italy
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Related Publications (5)
Caputo R, Fabi A, Romagnoli E, Baldini E, Grasso D, Fenderico N, Michelotti A. Ribociclib Plus Letrozole in Italian Male Patients with Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Advanced Breast Cancer: Case Studies of Phase 3b CompLEEment-1 Trial. Breast Cancer (Dove Med Press). 2022 Oct 18;14:351-362. doi: 10.2147/BCTT.S376902. eCollection 2022.
PMID: 36267663DERIVEDSalvador Bofill J, Moreno Anton F, Rodriguez Sanchez CA, Galve Calvo E, Hernando Melia C, Ciruelos Gil EM, Vidal M, Jimenez-Rodriguez B, De la Cruz Merino L, Martinez Janez N, Villanueva Vazquez R, de Toro Salas R, Anton Torres A, Alvarez Lopez IM, Gavila Gregori J, Quiroga Garcia V, Vicente Rubio E, De la Haba-Rodriguez J, Gonzalez-Santiago S, Diaz Fernandez N, Barnadas Molins A, Cantos Sanchez de Ibarguen B, Delgado Mingorance JI, Bellet Ezquerra M, de Casa S, Gimeno A, Martin M. Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2- advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial. Breast. 2022 Dec;66:77-84. doi: 10.1016/j.breast.2022.09.006. Epub 2022 Sep 28.
PMID: 36206609DERIVEDDe Laurentiis M, Caputo R, Mazza M, Mansutti M, Masetti R, Ballatore Z, Torrisi R, Michelotti A, Zambelli A, Ferro A, Generali D, Vici P, Coltelli L, Fabi A, Marchetti P, Ballestrero A, Spazzapan S, Frassoldati A, Sarobba MG, Grasso D, Zamagni C. Safety and Efficacy of Ribociclib in Combination with Letrozole in Patients with HR+, HER2- Advanced Breast Cancer: Results from the Italian Subpopulation of Phase 3b CompLEEment-1 Study. Target Oncol. 2022 Nov;17(6):615-625. doi: 10.1007/s11523-022-00913-x. Epub 2022 Sep 24.
PMID: 36152144DERIVEDCampone M, De Laurentiis M, Zamagni C, Kudryavcev I, Agterof M, Brown-Glaberman U, Palacova M, Chatterjee S, Menon-Singh L, Wu J, Martin M. Ribociclib plus letrozole in male patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: subgroup analysis of the phase IIIb CompLEEment-1 trial. Breast Cancer Res Treat. 2022 May;193(1):95-103. doi: 10.1007/s10549-022-06543-1. Epub 2022 Feb 25.
PMID: 35212906DERIVEDDe Laurentiis M, Borstnar S, Campone M, Warner E, Bofill JS, Jacot W, Dent S, Martin M, Ring A, Cottu P, Lu J, Ciruelos E, Azim HA, Chatterjee S, Zhou K, Wu J, Menon-Singh L, Zamagni C. Full population results from the core phase of CompLEEment-1, a phase 3b study of ribociclib plus letrozole as first-line therapy for advanced breast cancer in an expanded population. Breast Cancer Res Treat. 2021 Oct;189(3):689-699. doi: 10.1007/s10549-021-06334-0. Epub 2021 Aug 19.
PMID: 34414532DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Study director
- Organization
- Novartis Pharmaceuticals
Study Officials
- STUDY DIRECTOR
Novartis Pharmaceuticals
Novartis Pharmaceuticals
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 20, 2016
First Posted
October 21, 2016
Study Start
November 30, 2016
Primary Completion
November 8, 2019
Study Completion
November 9, 2022
Last Updated
October 24, 2023
Results First Posted
May 9, 2022
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will share
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 https://www.clinicalstudydatarequest.com/.