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
NCT ID: NCT02941926
Last Updated: 2023-10-24
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
3246 participants
INTERVENTIONAL
2016-11-30
2022-11-09
Brief Summary
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Detailed Description
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In the event that patients were still deriving benefit at the end of the Core phase and ribociclib was not approved or available and reimbursed, patients were transitioned to the Extension Phase and continued to receive study treatment until progression, intolerance, death or physician/patient decision. Only safety and clinical benefit (as assessed by investigator) data was collected in the Extension Phase. During the Extension Phase, if ribociclib became locally approved and reimbursed, patients were to be transitioned to prescription. Patients who completed the Extension Phase and continued to derive clinical benefit from the treatment based on the investigator's evaluation received ribociclib from prescription (if approved and reimbursed), another post-trial access program, or other drug access/support program(s).
Canadian sub-study: this sub-study was a multicenter Canadian exploratory correlative sample collection sub-study that aimed to better understand mechanisms of response and resistance to ribociclib in combination with letrozole therapy. This sub-study was available for all Canadian subjects enrolled on the main study and did not alter the planned treatment.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ribociclib + letrozole+goserelin/leuprolide
Participants 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.
Ribociclib
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
Letrozole was procured locally and administered orally once a day on a continuous daily schedule at a dose of 2.5 mg
Goserelin
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
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)
Interventions
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Ribociclib
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
Letrozole was procured locally and administered orally once a day on a continuous daily schedule at a dose of 2.5 mg
Goserelin
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
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)
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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.
1. 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.
2. 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.
3. 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 × 10\^9/L
* Platelets ≥ 100 × 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
* Serum creatinine \<1.5 mg/dl or creatinine clearance≥50 mL/min
* In absence of liver metastases, alanine aminotransferase (ALT) and aspartate aminotransferase (AST) should be below 2.5 × ULN. If the patient had liver metastases, ALT and AST should be \< 5 × ULN.
* Total serum bilirubin \< ULN; or total bilirubin ≤ 3.0 × ULN with direct bilirubin within normal range in patients with well-documented Gilbert's Syndrome
* Patient must have had a 12-lead ECG with ALL of the following parameters at screening:
* QTcF interval at screening \<450 msec (using Fridericia's correction)
* Resting heart rate ≥ 50 bpm
Exclusion Criteria
* 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.
* Patients who received ≤ 28 days of letrozole or anastrozole for advanced disease prior to inclusion in this trial were eligible.
* Any prior (neo) adjuvant anti-cancer therapy or prior chemotherapy for metastatic disease had to be stopped at least 5 half-lives or 7 days, whichever was longer, before study inclusion.
* Patient was concurrently using other anti-cancer therapy.
18 Years
ALL
No
Sponsors
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Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharmaceuticals
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Alaska Cancer Research and Education Center
Anchorage, Alaska, United States
Ironwood Cancer and Research Centers
Chandler, Arizona, United States
Arizona Oncology Associates
Phoenix, Arizona, United States
Arizona Oncology Associates Arizona Oncology Assoc. (2)
Tucson, Arizona, United States
Highlands Oncology Group
Fayetteville, Arkansas, United States
Beverly Hills Cancer Center
Beverly Hills, California, United States
Pacific Shores Medical Group SC
Long Beach, California, United States
USC Norris Cancer Center
Los Angeles, California, United States
University of California Irvine UC Irvine (11)
Orange, California, United States
Ventura County Hematology and Oncology
Oxnard, California, United States
PCR Oncology
Pismo Beach, California, United States
California Pacific Medical Center Onc Dept
San Francisco, California, United States
Centura Health Research Center Centura Health Research Center
Denver, Colorado, United States
Poudre Valley Hospital Poudre Valley Health System
Fort Collins, Colorado, United States
Valley View Hospital Cancer Center
Glenwood Springs, Colorado, United States
Florida Cancer Research Institute Dept of Oncology
Davie, Florida, United States
Foundation for Sickle Cell Disease Research
Hollywood, Florida, United States
Watson Clinic Center for Research 1730 Location
Lakeland, Florida, United States
Mid Florida Hematology and Onc Ctr
Orange, Florida, United States
Summit Cancer Care Summit Cancer Care (SC)
Savannah, Georgia, United States
John D Archbold Memorial Hospital John D. Archbold Mem Hosp (4)
Thomasville, Georgia, United States
Saint Alphonsus Regional Medical Center
Boise, Idaho, United States
Stroger Cook County Hospital Division of Hematology & Onc
Chicago, Illinois, United States
Joliet Oncology-Hematology Associates Presence Cancer Center
Joliet, Illinois, United States
Mid Illinois Hematology Oncology Mid Illinois Hema/Onc (3)
Normal, Illinois, United States
Alpha Med Physician Group, LLC
Tinley Park, Illinois, United States
Indian Univ Health Goshen Center forCancer SC
Goshen, Indiana, United States
Northwest Oncology
Munster, Indiana, United States
June E. Nylan Cancer Center
Sioux City, Iowa, United States
University of Kansas Medical Center University of Kansas Med Ctr 9
Kansas City, Kansas, United States
Sarah Cannon at Overland Park Regional Medical Center
Overland Park, Kansas, United States
John Ochsner Heart and Vascular Institute Clinical Trials
New Orleans, Louisiana, United States
Northern Light Mercy Hospital SC
Portland, Maine, United States
Greater Baltimore Medical Center Cancer Center Greater Baltimore Medical Ctr
Baltimore, Maryland, United States
Maryland Oncology Hematology P A Columbia
Rockville, Maryland, United States
Kaiser Permanente
Rockville, Maryland, United States
Medical Faculty Assc Inc Medical Faculty Assc., Inc. (2
Washington DC, Maryland, United States
Jackson Oncology Associates
Jackson, Mississippi, United States
Nebraska Hematology-Oncology, P.C.
Lincoln, Nebraska, United States
Nebraska Cancer Specialists Oncology Hematology West
Omaha, Nebraska, United States
Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)
Henderson, Nevada, United States
Trinitas Comprehensive Cancer Center
Elizabeth, New Jersey, United States
Englewood Health
Englewood, New Jersey, United States
The Valley Hospital / Luckow Pavillion
Paramus, New Jersey, United States
Somerset Hematology Oncology Associates Somerset Hematolgy Onc -MI
Somerset, New Jersey, United States
New Mexico Cancer Care Alliance .
Albuquerque, New Mexico, United States
San Juan Oncology Associates
Farmington, New Mexico, United States
Clinical Research Alliance
Lake Success, New York, United States
Eastchester Center for Cancer Care
The Bronx, New York, United States
Oncology Speciialists of Charlotte
Charlotte, North Carolina, United States
Aultman Cancer Center Main Centre
Canton, Ohio, United States
The Christ Hospital Cancer Center Research Program Linder Research Center
Cincinnati, Ohio, United States
University Hospitals of Cleveland Seidman Cancer Center Cleveland Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation Cleveland Clinic (5)
Cleveland, Ohio, United States
Dayton Physicians
Kettering, Ohio, United States
Oklahoma Cancer Specialists and Research Institute SC-2
Tulsa, Oklahoma, United States
Oregon Health Sciences University SC-5
Portland, Oregon, United States
McLeod Center for Cancer Treatment and Research
Florence, South Carolina, United States
Carolina Blood and Cancer Care of South Carolina
Rock Hill, South Carolina, United States
Millennium Research Clin Develop Millennium Oncology - FL
Houston, Texas, United States
Mays Cancer Ctr Uthsa Mdacc
San Antonio, Texas, United States
Hope Cancer Center of East Texas
Tyler, Texas, United States
Virginia Oncology Associates
Norfolk, Virginia, United States
PeaceHealth St Joseph Medical Center
Bellingham, Washington, United States
Providence Regional Medical Centre of Everett
Everett, Washington, United States
Kadlec Clinic Hematology and Onco
Kennewick, Washington, United States
Valley Medical Center Research Valley Medical Center
Renton, Washington, United States
Virginia Mason Medical Center-Oncology SC
Seattle, Washington, United States
Northwest Medical Specialties Dept.ofNW Med. Specialties
Tacoma, Washington, United States
Columbia St Mary s Hospital of Milwaukee St. Mary's Hospital Ozaukee
Milwaukee, Wisconsin, United States
Cheyenne Regional Medical Center Cheyenne Regional Med Ctr (3)
Cheyenne, Wyoming, United States
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Enschede, , Netherlands
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Goes, , Netherlands
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Groningen, , Netherlands
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Hilversum, , Netherlands
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Hoofddorp, , Netherlands
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Leeuwarden, , Netherlands
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Roermond, , Netherlands
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Rotterdam, , Netherlands
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Sittard-Geleen, , Netherlands
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The Hague, , Netherlands
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Utrecht, , Netherlands
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Zutphen, , Netherlands
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Zwolle, , Netherlands
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Grålum, , Norway
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Oslo, , Norway
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Oslo, , Norway
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Stavanger, , Norway
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Muscat, , Oman
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Panama City, , Panama
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City of Taguig, National Capital Region, Philippines
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Las Piñas, , Philippines
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San Juan City, , Philippines
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Żory, Silesian Voivodeship, Poland
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Bydgoszcz, , Poland
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Bytom, , Poland
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Gdansk, , Poland
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Krakow, , Poland
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Lublin, , Poland
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Opole, , Poland
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Rzeszów, , Poland
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Warsaw, , Poland
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Wroclaw, , Poland
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Braga, , Portugal
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Guimarães, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Lisbon, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Porto, , Portugal
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Leningrad Region, Russia, Russia
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Kazan', Tatarstan Republic, Russia
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Chelyabinsk, , Russia
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Irkutsk, , Russia
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Kaluga, , Russia
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Krasnoyarsk, , Russia
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Moscow, , Russia
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Moscow, , Russia
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Moscow Region Istra Village, , Russia
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Moscow Rerion Balashiha, , Russia
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Rostov-on-Don, , Russia
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Saint Petersburg, , Russia
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Saint Petersburg, , Russia
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Samara, , Russia
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Ufa, , Russia
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Yaroslavl, , Russia
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Dammam, , Saudi Arabia
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Mecca, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Riyadh, , Saudi Arabia
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Singapore, , Singapore
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Singapore, , Singapore
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Singapore, , Singapore
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Banská Bystrica, Slovak Republic, Slovakia
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Košice, , Slovakia
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Poprad, , Slovakia
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Ljubljana, , Slovenia
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Maribor, , Slovenia
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Elche, Alicante, Spain
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Almería, Andalusia, Spain
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Córdoba, Andalusia, Spain
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Granada, Andalusia, Spain
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Huelva, Andalusia, Spain
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Jaén, Andalusia, Spain
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Málaga, Andalusia, Spain
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Seville, Andalusia, Spain
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Seville, Andalusia, Spain
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Seville, Andalusia, Spain
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Palma de Mallorca, Balearic Islands, Spain
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Sabadell, Barcelona, Spain
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Bilbao, Basque Country, Spain
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Donostia / San Sebastian, Basque Country, Spain
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Jerez de la Frontera, Cadiz, Spain
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Salamanca, Castille and León, Spain
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Toledo, Castille-La Mancha, Spain
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Badalona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Barcelona, Catalonia, Spain
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Girona, Catalonia, Spain
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L'Hospitalet de Llobregat, Catalonia, Spain
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Lleida, Catalonia, Spain
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Badajoz, Extremadura, Spain
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Cáceres, Extremadura, Spain
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A Coruña, Galicia, Spain
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Santiago de Compostela, Galicia, Spain
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Las Palmas de Gran Canarias, Las Palmas de Gran Canaria, Spain
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El Palmar, Murcia, Spain
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Pamplona, Navarre, Spain
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Vigo, Pontevedra, Spain
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San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain
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Reus, Tarragona, Spain
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Alicante, Valencia, Spain
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Alicante, Valencia, Spain
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Castellon, Valencia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Valencia, Valencia, Spain
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Barcelona, , Spain
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Burgos, , Spain
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Granollers, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Madrid, , Spain
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Murcia, , Spain
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Valencia, , Spain
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Zaragoza, , Spain
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Gothenburg, , Sweden
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Örebro, , Sweden
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Stockholm, , Sweden
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Uppsala, , Sweden
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Vaxjo, , Sweden
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Taichung, , Taiwan
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Tainan City, , Taiwan
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Taipei, , Taiwan
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Songkhla, Hat Yai, Thailand
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Khon Kaen, THA, Thailand
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Bangkok, , Thailand
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Chiang Mai, , Thailand
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Peterborough, Cambridgeshire, United Kingdom
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Truro, Cornwall, United Kingdom
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Portsmouth, Hants, United Kingdom
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Maidstone, Kent, United Kingdom
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York, North Yorkshire, United Kingdom
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Aberdeen, Scotland, United Kingdom
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Ipswich, Suffolk, United Kingdom
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Guildford, Surrey, United Kingdom
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Sutton, Surrey, United Kingdom
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Bristol, , United Kingdom
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Cardiff, , United Kingdom
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East Sussex, , United Kingdom
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Edinburgh, , United Kingdom
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Exeter, , United Kingdom
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Glasgow, , United Kingdom
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Leeds, , United Kingdom
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Leicester, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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London, , United Kingdom
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Manchester, , United Kingdom
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Newcastle upon Tyne, , United Kingdom
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Nottingham, , United Kingdom
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Oxford, , United Kingdom
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Plymouth, , United Kingdom
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Preston, , United Kingdom
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Sheffield, , United Kingdom
Novartis Investigative Site
Stoke-on-Trent, , United Kingdom
Countries
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References
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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.
Salvador 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.
De 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.
Campone 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.
De 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.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003467-19
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CLEE011A2404
Identifier Type: -
Identifier Source: org_study_id
NCT03613220
Identifier Type: -
Identifier Source: nct_alias
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