AzTrials
AzTrials

Breast CancerPhase 3COMPLEEMENT-1NCT02941926

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

A Phase 3 study testing Ribociclib, Letrozole and Goserelin in people with Breast Cancer, run by Novartis Pharmaceuticals at 495 sites in 38 countries.

Completed

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

Official record

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Trial summary

The purpose of this study 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.. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Ribociclib, Letrozole and Goserelin
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3,246 participants
Where
495 sitesin 38 countries
Study dates
30 Nov 2016to 9 Nov 2022
Phase
Phase 3

Key requirements

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

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 21Show fewer
  • 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

Who cannot join

  • 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.
  • 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.

Trial locations and contacts

495 sites in 38 countries.

495 sites in 38 countries

Italy72 sites

  • Novartis Investigative Site

    Alessandria, AL, 15100

  • Novartis Investigative Site

    Ancona, AN, 60126

  • Novartis Investigative Site

    Arezzo, AR, 52100

  • Novartis Investigative Site

    Asti, AT, 14100

  • Novartis Investigative Site

    Avellino, AV, 83100

  • Novartis Investigative Site

    Aviano, PN, 33081

  • Novartis Investigative Site

    Bari, BA, 70124

  • Novartis Investigative Site

    Benevento, BN, 82100

  • Novartis Investigative Site

    Bergamo, BG, 24127

  • Novartis Investigative Site

    Bologna, BO, 40138

  • Novartis Investigative Site

    Bologna, BO, 40139

  • Novartis Investigative Site

    Brescia, BS, 25123

  • Novartis Investigative Site

    Brescia, BS, 25124

  • Novartis Investigative Site

    Brindisi, BR, 72100

  • Novartis Investigative Site

    Candiolo, TO, 10060

  • Novartis Investigative Site

    Catania, CT, 95124

  • Novartis Investigative Site

    Cona, FE, 44100

  • Novartis Investigative Site

    Cremona, CR, 26100

  • Novartis Investigative Site

    Cuneo, CN, 12100

  • Novartis Investigative Site

    Fano, PU, 61032

  • Novartis Investigative Site

    Florence, FI, 50134

  • Novartis Investigative Site

    Genova, GE, 16132

  • Novartis Investigative Site

    Grosseto, GR, 58100

  • Novartis Investigative Site

    L’Aquila, AQ, 67100

  • Novartis Investigative Site

    Lecco, LC, 23900

  • Novartis Investigative Site

    Livorno, LI, 57124

  • Novartis Investigative Site

    Lucca, LU, 55100

  • Novartis Investigative Site

    Messina, ME, 98158

  • Novartis Investigative Site

    Milan, MI, 20121

  • Novartis Investigative Site

    Milan, MI, 20132

  • Novartis Investigative Site

    Milan, MI, 20133

  • Novartis Investigative Site

    Milan, MI, 20141

  • Novartis Investigative Site

    Milan, MI, 20162

  • Novartis Investigative Site

    Mirano, VE, 30035

  • Novartis Investigative Site

    Modena, MO, 41124

  • Novartis Investigative Site

    Monserrato, CA, 09042

  • Novartis Investigative Site

    Monza, MB, 20900

  • Novartis Investigative Site

    Naples, 80131

  • Novartis Investigative Site

    Naples, 80138

  • Novartis Investigative Site

    Negrar, VR, 37024

  • Novartis Investigative Site

    Novara, 28100

  • Novartis Investigative Site

    Nuoro, NU, 08100

  • Novartis Investigative Site

    Padova, PD, 35100

  • Novartis Investigative Site

    Palermo, PA, 90127

  • Novartis Investigative Site

    Palermo, PA, 90146

  • Novartis Investigative Site

    Parma, PR, 43100

  • Novartis Investigative Site

    Pavia, PV, 27100

  • Novartis Investigative Site

    Pisa, PI, 56126

  • Novartis Investigative Site

    Prato, PO, 59100

  • Novartis Investigative Site

    Province of Macerata, MC, 62100

  • Novartis Investigative Site

    Reggio Calabria, RC, 89124

  • Novartis Investigative Site

    Reggio Emilia, RE, 42123

  • Novartis Investigative Site

    Roma, RM, 00128

  • Novartis Investigative Site

    Roma, RM, 00152

  • Novartis Investigative Site

    Roma, RM, 00161

  • Novartis Investigative Site

    Roma, RM, 00168

  • Novartis Investigative Site

    Roma, RM, 00189

  • Novartis Investigative Site

    Rozzano, MI, 20089

  • Novartis Investigative Site

    Salerno, SA, 84131

  • Novartis Investigative Site

    San Giovanni Rotondo, FG, 71013

  • Novartis Investigative Site

    Saronno, VA, 21047

  • Novartis Investigative Site

    Sassari, SS, 07100

  • Novartis Investigative Site

    Savona, SV, 17100

  • Novartis Investigative Site

    Siena, SI, 53100

  • Novartis Investigative Site

    Taormina, ME, 98039

  • Novartis Investigative Site

    Terni, TR, 05100

  • Novartis Investigative Site

    Torino, TO, 10126

  • Novartis Investigative Site

    Trento, TN, 38100

  • Novartis Investigative Site

    Treviglio, BG, 24047

  • Novartis Investigative Site

    Udine, UD, 33100

  • Novartis Investigative Site

    Verona, VR, 37126

  • Novartis Investigative Site

    Viterbo, VT, 01100

Other trials in Italy

United States71 sites

  • New Mexico Cancer Care Alliance .

    Albuquerque, New Mexico, 87106

  • Alaska Cancer Research and Education Center

    Anchorage, Alaska, 99508

  • Greater Baltimore Medical Center Cancer Center Greater Baltimore Medical Ctr

    Baltimore, Maryland, 21204-6831

  • PeaceHealth St Joseph Medical Center

    Bellingham, Washington, 98225

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Saint Alphonsus Regional Medical Center

    Boise, Idaho, 83706

  • Aultman Cancer Center Main Centre

    Canton, Ohio, 44710

  • Ironwood Cancer and Research Centers

    Chandler, Arizona, 85224

  • Oncology Speciialists of Charlotte

    Charlotte, North Carolina, 28207

  • Cheyenne Regional Medical Center Cheyenne Regional Med Ctr (3)

    Cheyenne, Wyoming, 82001

  • Stroger Cook County Hospital Division of Hematology & Onc

    Chicago, Illinois, 60612

  • The Christ Hospital Cancer Center Research Program Linder Research Center

    Cincinnati, Ohio, 45219

  • University Hospitals of Cleveland Seidman Cancer Center Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation Cleveland Clinic (5)

    Cleveland, Ohio, 44195

  • Florida Cancer Research Institute Dept of Oncology

    Davie, Florida, 33328

  • Centura Health Research Center Centura Health Research Center

    Denver, Colorado, 80210

  • Trinitas Comprehensive Cancer Center

    Elizabeth, New Jersey, 07207

  • Englewood Health

    Englewood, New Jersey, 07631

  • Providence Regional Medical Centre of Everett

    Everett, Washington, 98201

  • San Juan Oncology Associates

    Farmington, New Mexico, 87401

  • Highlands Oncology Group

    Fayetteville, Arkansas, 72703

  • McLeod Center for Cancer Treatment and Research

    Florence, South Carolina, 29506

  • Poudre Valley Hospital Poudre Valley Health System

    Fort Collins, Colorado, 80528

  • Valley View Hospital Cancer Center

    Glenwood Springs, Colorado, 81601

  • Indian Univ Health Goshen Center forCancer SC

    Goshen, Indiana, 46526

  • Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)

    Henderson, Nevada, 89052

  • Foundation for Sickle Cell Disease Research

    Hollywood, Florida, 33021

  • Millennium Research Clin Develop Millennium Oncology - FL

    Houston, Texas, 77090

  • Jackson Oncology Associates

    Jackson, Mississippi, 39202

  • Joliet Oncology-Hematology Associates Presence Cancer Center

    Joliet, Illinois, 60435

  • University of Kansas Medical Center University of Kansas Med Ctr 9

    Kansas City, Kansas, 66160-7330

  • Kadlec Clinic Hematology and Onco

    Kennewick, Washington, 99336

  • Dayton Physicians

    Kettering, Ohio, 45409

  • Clinical Research Alliance

    Lake Success, New York, 11042

  • Watson Clinic Center for Research 1730 Location

    Lakeland, Florida, 33805

  • Nebraska Hematology-Oncology, P.C.

    Lincoln, Nebraska, 68506

  • Pacific Shores Medical Group SC

    Long Beach, California, 90813

  • USC Norris Cancer Center

    Los Angeles, California, 90033

  • Columbia St Mary s Hospital of Milwaukee St. Mary's Hospital Ozaukee

    Milwaukee, Wisconsin, 53211

  • Northwest Oncology

    Munster, Indiana, 46321

  • John Ochsner Heart and Vascular Institute Clinical Trials

    New Orleans, Louisiana, 70121

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Mid Illinois Hematology Oncology Mid Illinois Hema/Onc (3)

    Normal, Illinois, 61761

  • Nebraska Cancer Specialists Oncology Hematology West

    Omaha, Nebraska, 68154

  • University of California Irvine UC Irvine (11)

    Orange, California, 92868

  • Mid Florida Hematology and Onc Ctr

    Orange, Florida, 32763

  • Sarah Cannon at Overland Park Regional Medical Center

    Overland Park, Kansas, 66209

  • Ventura County Hematology and Oncology

    Oxnard, California, 93030

  • The Valley Hospital / Luckow Pavillion

    Paramus, New Jersey, 07652

  • Arizona Oncology Associates

    Phoenix, Arizona, 85016

  • PCR Oncology

    Pismo Beach, California, 93449

  • Northern Light Mercy Hospital SC

    Portland, Maine, 04102

  • Oregon Health Sciences University SC-5

    Portland, Oregon, 97239

  • Valley Medical Center Research Valley Medical Center

    Renton, Washington, 98055

  • Carolina Blood and Cancer Care of South Carolina

    Rock Hill, South Carolina, 29732

  • Maryland Oncology Hematology P A Columbia

    Rockville, Maryland, 20850

  • Kaiser Permanente

    Rockville, Maryland, 20879

  • Mays Cancer Ctr Uthsa Mdacc

    San Antonio, Texas, 78229

  • California Pacific Medical Center Onc Dept

    San Francisco, California, 94120-7999

  • Summit Cancer Care Summit Cancer Care (SC)

    Savannah, Georgia, 31405

  • Virginia Mason Medical Center-Oncology SC

    Seattle, Washington, 98101

  • June E. Nylan Cancer Center

    Sioux City, Iowa, 51101

  • Somerset Hematology Oncology Associates Somerset Hematolgy Onc -MI

    Somerset, New Jersey, 08873

  • Northwest Medical Specialties Dept.ofNW Med. Specialties

    Tacoma, Washington, 98405

  • Eastchester Center for Cancer Care

    The Bronx, New York, 10469

  • John D Archbold Memorial Hospital John D. Archbold Mem Hosp (4)

    Thomasville, Georgia, 31792

  • Alpha Med Physician Group, LLC

    Tinley Park, Illinois, 60487

  • Arizona Oncology Associates Arizona Oncology Assoc. (2)

    Tucson, Arizona, 85745

  • Oklahoma Cancer Specialists and Research Institute SC-2

    Tulsa, Oklahoma, 74136

  • Hope Cancer Center of East Texas

    Tyler, Texas, 75701

  • Medical Faculty Assc Inc Medical Faculty Assc., Inc. (2

    Washington DC, Maryland, 20037

Other trials in United States

Spain54 sites

  • Novartis Investigative Site

    A Coruña, Galicia, 15006

  • Novartis Investigative Site

    Alicante, Valencia, 03010

  • Novartis Investigative Site

    Alicante, Valencia, 03550

  • Novartis Investigative Site

    Almería, Andalusia, 04009

  • Novartis Investigative Site

    Badajoz, Extremadura, 06080

  • Novartis Investigative Site

    Badalona, Catalonia, 08916

  • Novartis Investigative Site

    Barcelona, Catalonia, 08024

  • Novartis Investigative Site

    Barcelona, Catalonia, 08035

  • Novartis Investigative Site

    Barcelona, Catalonia, 08036

  • Novartis Investigative Site

    Barcelona, 08041

  • Novartis Investigative Site

    Bilbao, Basque Country, 48013

  • Novartis Investigative Site

    Burgos, 09006

  • Novartis Investigative Site

    Cáceres, Extremadura, 10003

  • Novartis Investigative Site

    Castellon, Valencia, 12002

  • Novartis Investigative Site

    Córdoba, Andalusia, 14004

  • Novartis Investigative Site

    Donostia / San Sebastian, Basque Country, 20080

  • Novartis Investigative Site

    El Palmar, Murcia, 30120

  • Novartis Investigative Site

    Elche, Alicante, 03203

  • Novartis Investigative Site

    Girona, Catalonia, 17007

  • Novartis Investigative Site

    Granada, Andalusia, 18014

  • Novartis Investigative Site

    Granollers, 08402

  • Novartis Investigative Site

    Huelva, Andalusia, 21005

  • Novartis Investigative Site

    Jaén, Andalusia, 23007

  • Novartis Investigative Site

    Jerez de la Frontera, Cadiz, 11407

  • Novartis Investigative Site

    L'Hospitalet de Llobregat, Catalonia, 08907

  • Novartis Investigative Site

    Las Palmas de Gran Canarias, Las Palmas de Gran Canaria, 35016

  • Novartis Investigative Site

    Lleida, Catalonia, 25198

  • Novartis Investigative Site

    Madrid, 28006

  • Novartis Investigative Site

    Madrid, 28009

  • Novartis Investigative Site

    Madrid, 28034

  • Novartis Investigative Site

    Madrid, 28040

  • Novartis Investigative Site

    Madrid, 28041

  • Novartis Investigative Site

    Madrid, 28046

  • Novartis Investigative Site

    Madrid, 28222

  • Novartis Investigative Site

    Málaga, Andalusia, 29010

  • Novartis Investigative Site

    Murcia, 30008

  • Novartis Investigative Site

    Palma de Mallorca, Balearic Islands, 07120

  • Novartis Investigative Site

    Pamplona, Navarre, 31008

  • Novartis Investigative Site

    Reus, Tarragona, 43201

  • Novartis Investigative Site

    Sabadell, Barcelona, 08208

  • Novartis Investigative Site

    Salamanca, Castille and León, 37007

  • Novartis Investigative Site

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • Novartis Investigative Site

    Santiago de Compostela, Galicia, 15706

  • Novartis Investigative Site

    Seville, Andalusia, 41009

  • Novartis Investigative Site

    Seville, Andalusia, 41013

  • Novartis Investigative Site

    Seville, Andalusia, 41014

  • Novartis Investigative Site

    Toledo, Castille-La Mancha, 45071

  • Novartis Investigative Site

    Valencia, Valencia, 46009

  • Novartis Investigative Site

    Valencia, Valencia, 46010

  • Novartis Investigative Site

    Valencia, Valencia, 46014

  • Novartis Investigative Site

    Valencia, Valencia, 46015

  • Novartis Investigative Site

    Valencia, 46026

  • Novartis Investigative Site

    Vigo, Pontevedra, 36212

  • Novartis Investigative Site

    Zaragoza, 50009

Other trials in Spain

France44 sites

  • Novartis Investigative Site

    Albi, 81000

  • Novartis Investigative Site

    Angers, 49055

  • Novartis Investigative Site

    Avignon, 84082

  • Novartis Investigative Site

    Besançon, 25030

  • Novartis Investigative Site

    Bobigny, 93009

  • Novartis Investigative Site

    Bordeaux, 33000

  • Novartis Investigative Site

    Bordeaux, 33076

  • Novartis Investigative Site

    Caen, 14021

  • Novartis Investigative Site

    Clermont-Ferrand, 63011

  • Novartis Investigative Site

    Colmar, 68024

  • Novartis Investigative Site

    Corbeil-Essonnes, 91100

  • Novartis Investigative Site

    Créteil, 94010

  • Novartis Investigative Site

    Dijon, Cote D Or, 21034

  • Novartis Investigative Site

    Le Mans, 72015

  • Novartis Investigative Site

    Lille, 59020

  • Novartis Investigative Site

    Limoges, Haute Vienne, 87000

  • Novartis Investigative Site

    Limoges, 87000

  • Novartis Investigative Site

    Lyon, 69373

  • Novartis Investigative Site

    Marseille, 13273

  • Novartis Investigative Site

    Mont-de-Marsan, 40024

  • Novartis Investigative Site

    Montpellier, 34070

  • Novartis Investigative Site

    Montpellier, 34298

  • Novartis Investigative Site

    Nancy, 54000

  • Novartis Investigative Site

    Nantes, 44277

  • Novartis Investigative Site

    Nice, Alpes Maritimes, 06189

  • Novartis Investigative Site

    Paris, 75012

  • Novartis Investigative Site

    Paris, 75231

  • Novartis Investigative Site

    Paris, 75475

  • Novartis Investigative Site

    Paris, 75651

  • Novartis Investigative Site

    Paris, 75970

  • Novartis Investigative Site

    Périgueux, 24004

  • Novartis Investigative Site

    Pierre-Bénite, 69495

  • Novartis Investigative Site

    Plerin Sur Mer, 22190

  • Novartis Investigative Site

    Reims, Marne, 51056

  • Novartis Investigative Site

    Reims, 51100

  • Novartis Investigative Site

    Rouen, 76038

  • Novartis Investigative Site

    Saint-Cloud, Hauts De Seine, 92210

  • Novartis Investigative Site

    Saint-Herblain, 44805

  • Novartis Investigative Site

    Strasbourg, 67010

  • Novartis Investigative Site

    Strasbourg, 67091

  • Novartis Investigative Site

    Toulon La Seyne Sur Mer, 83056

  • Novartis Investigative Site

    Tours, Indre Et Loire, 37044

  • Novartis Investigative Site

    Troyes, 10003

  • Novartis Investigative Site

    Vandœuvre-lès-Nancy, 54519

Other trials in France

Canada32 sites

  • Novartis Investigative Site

    Barrie, Ontario, L4M 6M2

  • Novartis Investigative Site

    Calgary, Alberta, T2N 4N2

  • Novartis Investigative Site

    Cambridge, Ontario, N1R 3G2

  • Novartis Investigative Site

    Edmonton, Alberta, T6G 1Z2

  • Novartis Investigative Site

    Greater Sudbury, Ontario, P3E 5J1

  • Novartis Investigative Site

    Greenfield Park, Quebec, J4V 2H1

  • Novartis Investigative Site

    Halifax, Nova Scotia, B3H 2Y9

  • Novartis Investigative Site

    Hamilton, Ontario, L8V 5C2

  • Novartis Investigative Site

    Kelowna, British Columbia, V1Y 5L3

  • Novartis Investigative Site

    Kingston, Ontario, K7L 5P9

  • Novartis Investigative Site

    Kitchener, Ontario, N2G 1G3

  • Novartis Investigative Site

    Laval, Quebec, H7M 3L9

  • Novartis Investigative Site

    London, Ontario, N6A 4G4

  • Novartis Investigative Site

    Moncton, New Brunswick, E1C 6Z8

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1E2

  • Novartis Investigative Site

    Montreal, Quebec, H3T 1M5

  • Novartis Investigative Site

    Montreal, Quebec, H4J 1C5

  • Novartis Investigative Site

    Newmarket, Ontario, L3Y 2P9

  • Novartis Investigative Site

    North York, Ontario, M2K1E1

  • Novartis Investigative Site

    Oshawa, Ontario, L1G 2B9

  • Novartis Investigative Site

    Ottawa, Ontario, KIH 7W9

  • Novartis Investigative Site

    Québec, Quebec, G1S 4L8

  • Novartis Investigative Site

    Regina, Saskatchewan, S4T 7T1

  • Novartis Investigative Site

    Saskatoon, Saskatchewan, S7N 4H4

  • Novartis Investigative Site

    Sault Ste. Marie, Ontario, P6B 0A8

  • Novartis Investigative Site

    Sherbrooke, Quebec, J1H 5N4

  • Novartis Investigative Site

    Surrey, British Columbia, V3V 1Z2

  • Novartis Investigative Site

    Toronto, Ontario, M3M 0B2

  • Novartis Investigative Site

    Toronto, Ontario, M4N 3M5

  • Novartis Investigative Site

    Toronto, Ontario, M5B 1W8

  • Novartis Investigative Site

    Vancouver, British Columbia, V5Z 4E6

  • Novartis Investigative Site

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

United Kingdom28 sites

  • Novartis Investigative Site

    Aberdeen, Scotland, AB25 2ZN

  • Novartis Investigative Site

    Bristol, BS2 8ED

  • Novartis Investigative Site

    Cardiff, CF14 2TL

  • Novartis Investigative Site

    East Sussex, BN2 5BE

  • Novartis Investigative Site

    Edinburgh, EH4 2XU

  • Novartis Investigative Site

    Exeter, EX2 5DW

  • Novartis Investigative Site

    Glasgow, G12 0YN

  • Novartis Investigative Site

    Guildford, Surrey, GU2 7XX

  • Novartis Investigative Site

    Ipswich, Suffolk, IP4 5PD

  • Novartis Investigative Site

    Leeds, LS9 7TF

  • Novartis Investigative Site

    Leicester, LE1 5WW

  • Novartis Investigative Site

    London, NW1 2PJ

  • Novartis Investigative Site

    London, SW3 6JJ

  • Novartis Investigative Site

    London, W8 6RF

  • Novartis Investigative Site

    Maidstone, Kent, ME16 9QQ

  • Novartis Investigative Site

    Manchester, M20 4BX

  • Novartis Investigative Site

    Newcastle upon Tyne, NE7 7DN

  • Novartis Investigative Site

    Nottingham, NG5 1PB

  • Novartis Investigative Site

    Oxford, OX3 7LJ

  • Novartis Investigative Site

    Peterborough, Cambridgeshire, PE3 9GZ

  • Novartis Investigative Site

    Plymouth, PL6 8DH

  • Novartis Investigative Site

    Portsmouth, Hants, PO6 3LY

  • Novartis Investigative Site

    Preston, PR2 9HT

  • Novartis Investigative Site

    Sheffield, S10 2SJ

  • Novartis Investigative Site

    Stoke-on-Trent, ST4 6QG

  • Novartis Investigative Site

    Sutton, Surrey, SM2 5PT

  • Novartis Investigative Site

    Truro, Cornwall, TR1 3LJ

  • Novartis Investigative Site

    York, North Yorkshire, YO31 8HE

Other trials in United Kingdom

Netherlands24 sites

  • Novartis Investigative Site

    's-Hertogenbosch, 5223 GZ

  • Novartis Investigative Site

    Apeldoorn, DZ, 7334

  • Novartis Investigative Site

    Arnhem, Gelderland, 6815 AD

  • Novartis Investigative Site

    Beverwijk, 1942 LE

  • Novartis Investigative Site

    Breda, 4818 CK

  • Novartis Investigative Site

    Delft, 2625 AD

  • Novartis Investigative Site

    Dordrecht, 3318AT

  • Novartis Investigative Site

    Ede, 6716 RP

  • Novartis Investigative Site

    Eindhoven, 5623EJ

  • Novartis Investigative Site

    Enschede, 7513 ER

  • Novartis Investigative Site

    Goes, 4462 RA

  • Novartis Investigative Site

    Groningen, 9728 NZ

  • Novartis Investigative Site

    Hilversum, XZ1213

  • Novartis Investigative Site

    Hoofddorp, 2134 TM

  • Novartis Investigative Site

    Leeuwarden, 8934 AD

  • Novartis Investigative Site

    Maastricht, AZ, 5800

  • Novartis Investigative Site

    Roermond, 6043 CV

  • Novartis Investigative Site

    Rotterdam, 3079 DZ

  • Novartis Investigative Site

    Sittard-Geleen, 6162 BG

  • Novartis Investigative Site

    The Hague, 2545 CH

  • Novartis Investigative Site

    Utrecht, 3543 AZ

  • Novartis Investigative Site

    Venray, CE, 5801

  • Novartis Investigative Site

    Zutphen, 7207 AE

  • Novartis Investigative Site

    Zwolle, 8025 AB

Other trials in Netherlands

Belgium20 sites

  • Novartis Investigative Site

    Antwerp, 2020

  • Novartis Investigative Site

    Bonheiden, 2820

  • Novartis Investigative Site

    Bruges, 8000

  • Novartis Investigative Site

    Brussels, 1000

  • Novartis Investigative Site

    Brussels, 1090

  • Novartis Investigative Site

    Brussels, BE-B-1200

  • Novartis Investigative Site

    Charleroi, 6000

  • Novartis Investigative Site

    Genk, 3600

  • Novartis Investigative Site

    Ghent, 9000

  • Novartis Investigative Site

    Hasselt, 3500

  • Novartis Investigative Site

    Kortrijk, 8500

  • Novartis Investigative Site

    Leuven, 3000

  • Novartis Investigative Site

    Liège, 4000

  • Novartis Investigative Site

    Luxembourg, Luxembourg, 1210

  • Novartis Investigative Site

    Mons, 7000

  • Novartis Investigative Site

    Namur, 5000

  • Novartis Investigative Site

    Roeselare, 8800

  • Novartis Investigative Site

    Sint-Niklaas, Oost Vlaanderen, 9100

  • Novartis Investigative Site

    Verviers, 4800

  • Novartis Investigative Site

    Wilrijk, 2610

Other trials in Belgium

Russia16 sites

  • Novartis Investigative Site

    Chelyabinsk, 454087

  • Novartis Investigative Site

    Irkutsk, 664035

  • Novartis Investigative Site

    Kaluga, 248007

  • Novartis Investigative Site

    Kazan', Tatarstan Republic, 420029

  • Novartis Investigative Site

    Krasnoyarsk, 660022

  • Novartis Investigative Site

    Leningrad Region, Russia, 188663

  • Novartis Investigative Site

    Moscow, 115478

  • Novartis Investigative Site

    Moscow, 125284

  • Novartis Investigative Site

    Moscow Region Istra Village, 143423

  • Novartis Investigative Site

    Moscow Rerion Balashiha, 143900

  • Novartis Investigative Site

    Rostov-on-Don, 344037

  • Novartis Investigative Site

    Saint Petersburg, 197022

  • Novartis Investigative Site

    Saint Petersburg, 197758

  • Novartis Investigative Site

    Samara, 443031

  • Novartis Investigative Site

    Ufa, 450054

  • Novartis Investigative Site

    Yaroslavl, 150054

Other trials in Russia

Czechia13 sites

  • Novartis Investigative Site

    Brno, Czech Republic, 656 53

  • Novartis Investigative Site

    Brno, 625 00

  • Novartis Investigative Site

    České Budějovice, 370 87

  • Novartis Investigative Site

    Hradec Králové, CZE, 500 05

  • Novartis Investigative Site

    Liberec, Czech Republic, 46063

  • Novartis Investigative Site

    Olomouc, CZE, 779 00

  • Novartis Investigative Site

    Pardubice, 532 03

  • Novartis Investigative Site

    Prague, Czech Republic, 180 00

  • Novartis Investigative Site

    Prague, 100 34

  • Novartis Investigative Site

    Prague, 12808

  • Novartis Investigative Site

    Prague, 140 59

  • Novartis Investigative Site

    Prague, 150 00

  • Novartis Investigative Site

    Zlín, Czech Republic, 762 75

Other trials in Czechia

India11 sites

  • Novartis Investigative Site

    Admedabad, Gujarat, 380060

  • Novartis Investigative Site

    Bangalore, Karnataka, 560027

  • Novartis Investigative Site

    Delhi, 110 085

  • Novartis Investigative Site

    Hyderabad, Andhra Pradesh, 500 034

  • Novartis Investigative Site

    Jaipur, Rajasthan, 302017

  • Novartis Investigative Site

    Kolkata, West Bengal, 700160

  • Novartis Investigative Site

    Nashik, Maharashtra, 422 004

  • Novartis Investigative Site

    New Delhi, National Capital Territory of Delhi, 110092

  • Novartis Investigative Site

    Pune, Maharashtra, 411013

  • Novartis Investigative Site

    Tamil Nadu, Chennai, 600035

  • Novartis Investigative Site

    Vellore, Tamil Nadu, 632 004

Other trials in India

Poland10 sites

  • Novartis Investigative Site

    Bydgoszcz, 85 796

  • Novartis Investigative Site

    Bytom, 41-902

  • Novartis Investigative Site

    Gdansk, 80 952

  • Novartis Investigative Site

    Krakow, 31-501

  • Novartis Investigative Site

    Lublin, 20 090

  • Novartis Investigative Site

    Opole, 45-061

  • Novartis Investigative Site

    Rzeszów, 35-021

  • Novartis Investigative Site

    Warsaw, 02 781

  • Novartis Investigative Site

    Wroclaw, 53 413

  • Novartis Investigative Site

    Żory, Silesian Voivodeship, 44-240

Other trials in Poland

Portugal9 sites

  • Novartis Investigative Site

    Braga, 4710243

  • Novartis Investigative Site

    Guimarães, 4835-044

  • Novartis Investigative Site

    Lisbon, 1400-038

  • Novartis Investigative Site

    Lisbon, 1500 650

  • Novartis Investigative Site

    Lisbon, 1649-035

  • Novartis Investigative Site

    Lisbon, 1998-018

  • Novartis Investigative Site

    Porto, 4099-001

  • Novartis Investigative Site

    Porto, 4200-072

  • Novartis Investigative Site

    Porto, 4200-319

Other trials in Portugal

Austria8 sites

  • Novartis Investigative Site

    Graz, 8036

  • Novartis Investigative Site

    Innsbruck, Tyrol, 6020

  • Novartis Investigative Site

    Leoben, A 8700

  • Novartis Investigative Site

    Rankweil, A-6830

  • Novartis Investigative Site

    Salzburg, 5020

  • Novartis Investigative Site

    Vienna, 1090

  • Novartis Investigative Site

    Vienna, A 1090

  • Novartis Investigative Site

    Vienna, A-1130

Other trials in Austria

Greece7 sites

  • Novartis Investigative Site

    Athens, 115 28

  • Novartis Investigative Site

    Athens, GR 115 22

  • Novartis Investigative Site

    Athens, GR14564

  • Novartis Investigative Site

    Ioannina, GR, 455 00

  • Novartis Investigative Site

    Pátrai, 265 00

  • Novartis Investigative Site

    Thessaloniki, GR, 54645

  • Novartis Investigative Site

    Thessaloniki, 540 07

Other trials in Greece

Bulgaria6 sites

  • Novartis Investigative Site

    Gabrovo, 5300

  • Novartis Investigative Site

    Plovdiv, 4004

  • Novartis Investigative Site

    Sofia, 1303

  • Novartis Investigative Site

    Sofia, 1527

  • Novartis Investigative Site

    Sofia, 1606

  • Novartis Investigative Site

    Sofia, 1756

Other trials in Bulgaria

Israel6 sites

  • Novartis Investigative Site

    Beersheba, 8457108

  • Novartis Investigative Site

    Haifa, 3109601

  • Novartis Investigative Site

    Jerusalem, 9112001

  • Novartis Investigative Site

    Petah Tikva, 4941492

  • Novartis Investigative Site

    Ramat Gan, 52621

  • Novartis Investigative Site

    Tel Aviv, 6423906

Other trials in Israel

Argentina5 sites

  • Novartis Investigative Site

    CABA, Buenos Aires, C1125ABD

  • Novartis Investigative Site

    CABA, Buenos Aires, C1426ANZ

  • Novartis Investigative Site

    La Rioja, 5300

  • Novartis Investigative Site

    Rosario, Santa Fe Province, S2000KZE

  • Novartis Investigative Site

    San Miguel de Tucumán, Tucumán Province, T4000IAK

Other trials in Argentina

Hungary5 sites

  • Novartis Investigative Site

    Budapest, 1134

  • Novartis Investigative Site

    Budapest, H 1122

  • Novartis Investigative Site

    Budapest, H-1032

  • Novartis Investigative Site

    Debrecen, 4032

  • Novartis Investigative Site

    Szeged, 6725

Other trials in Hungary

Malaysia5 sites

  • Novartis Investigative Site

    Kuala Lumpur, Kuala Lumpur, 50586

  • Novartis Investigative Site

    Kuala Lumpur, 59100

  • Novartis Investigative Site

    Petaling Jaya, Selangor, 46050

  • Novartis Investigative Site

    Putrajaya, Kuala Lumpur, 62250

  • Novartis Investigative Site

    Tanjong Bungah, Pulau Pinang, 11200

Other trials in Malaysia

Sweden5 sites

  • Novartis Investigative Site

    Gothenburg, SE-431 45

  • Novartis Investigative Site

    Örebro, 701 85

  • Novartis Investigative Site

    Stockholm, SE-118 83

  • Novartis Investigative Site

    Uppsala, 751 85

  • Novartis Investigative Site

    Vaxjo, SE-351 85

Other trials in Sweden

Norway4 sites

  • Novartis Investigative Site

    Grålum, 1714

  • Novartis Investigative Site

    Oslo, 0379

  • Novartis Investigative Site

    Oslo, NO 0450

  • Novartis Investigative Site

    Stavanger, NO-4068

Other trials in Norway

Saudi Arabia4 sites

  • Novartis Investigative Site

    Dammam, 15215

  • Novartis Investigative Site

    Mecca, 57657

  • Novartis Investigative Site

    Riyadh, 11211

  • Novartis Investigative Site

    Riyadh, 11426

Other trials in Saudi Arabia

Thailand4 sites

  • Novartis Investigative Site

    Bangkok, 10400

  • Novartis Investigative Site

    Chiang Mai, 50200

  • Novartis Investigative Site

    Khon Kaen, THA, 40002

  • Novartis Investigative Site

    Songkhla, Hat Yai, 90110

Other trials in Thailand

Finland3 sites

  • Novartis Investigative Site

    Helsinki, 00029

  • Novartis Investigative Site

    Oulu, FIN-90220

  • Novartis Investigative Site

    Tampere, FIN-33521

Other trials in Finland

Hong Kong3 sites

  • Novartis Investigative Site

    Hong Kong

  • Novartis Investigative Site

    Kowloon

  • Novartis Investigative Site

    Pokfulam, Hong Kong

Other trials in Hong Kong

Lebanon3 sites

  • Novartis Investigative Site

    Beirut, 10999

  • Novartis Investigative Site

    El Achrafiyé, 166830

  • Novartis Investigative Site

    Saida, 652

Other trials in Lebanon

Mexico3 sites

  • Novartis Investigative Site

    Mexico City, 01120

  • Novartis Investigative Site

    Mexico City, 04700

  • Novartis Investigative Site

    Monterrey, Nuevo León, 64710

Other trials in Mexico

Philippines3 sites

  • Novartis Investigative Site

    City of Taguig, National Capital Region, 1634

  • Novartis Investigative Site

    Las Piñas, 1740

  • Novartis Investigative Site

    San Juan City, 1500

Other trials in Philippines

Singapore3 sites

  • Novartis Investigative Site

    Singapore, 217562

  • Novartis Investigative Site

    Singapore, 258500

  • Novartis Investigative Site

    Singapore, 308433

Other trials in Singapore

Slovakia3 sites

  • Novartis Investigative Site

    Banská Bystrica, Slovak Republic, 97401

  • Novartis Investigative Site

    Košice, 04191

  • Novartis Investigative Site

    Poprad, 058 01

Other trials in Slovakia

Taiwan3 sites

  • Novartis Investigative Site

    Taichung, 40447

  • Novartis Investigative Site

    Tainan, 70403

  • Novartis Investigative Site

    Taipei, 114

Other trials in Taiwan

Denmark2 sites

  • Novartis Investigative Site

    Copenhagen, DK-2100

  • Novartis Investigative Site

    Vejle, 7100

Other trials in Denmark

Slovenia2 sites

  • Novartis Investigative Site

    Ljubljana, 1000

  • Novartis Investigative Site

    Maribor, 2000

Other trials in Slovenia

Chile1 site

  • Novartis Investigative Site

    Santiago, 8420383

Other trials in Chile

Jordan1 site

  • Novartis Investigative Site

    Amman, 11941

Other trials in Jordan

Oman1 site

  • Novartis Investigative Site

    Muscat, 123

Other trials in Oman

Panama1 site

  • Novartis Investigative Site

    Panama City, 0801

Other trials in Panama

About this study

Official title: 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

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..

Read the detailed description

This was an open-label, single arm, multi-center Phase IIIb study. The study was composed of 2 phases: Core Phase and Extension Phase. In the Core Phase, safety and efficacy data was collected. The study treatment during the Core Phase was provided until disease progression, death, unacceptable toxicities, physician's decision, subject/guardian's decision, protocol deviation, study termination by sponsor, lost to follow-up, technical problems or up to 18 months after LPFV.

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
Breast Cancer
Being tested
Ribociclib, Letrozole, Goserelin, Leuprolide
Keywords
HR-positive HER2-negative, advanced breast cancer, LEE011, ribociclib, letrozole, goserelin, CDK, CDK4, CDK6, CDK4/6, Phase IIIb, ER-positive, PR-positive, premenopausal, postmenopausal, men with advanced breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

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

  • RibociclibDrug

    Also called LEE011

    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

  • LetrozoleDrug

    Letrozole was procured locally and administered orally once a day on a continuous daily schedule at a dose of 2.5 mg

  • GoserelinDrug

    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)

  • LeuprolideDrug

    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)

Study groups in NCT02941926
Study groupRoleWhat they receive
Ribociclib + letrozole+goserelin/leuprolideExperimentalParticipants 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.
Receives: Drug: Ribociclib; Drug: Letrozole; Drug: Goserelin; Drug: Leuprolide

What is being measured

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

  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.

    Measured: 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)

  1. Time-to-Progression (TTP) Based on Investigator's Assessment (Core Phase)

    Time to progression (TTP) is defined as time from date of start of treatment to the date of first documented progression or death due to underlying cancer. Participants with symptoms of rapidly progressing disease without radiologic evidence were classified as progression only when clear evidence of clinical deterioration was documented and/or patient discontinued due to 'Disease progression' or death due to study indication. When there was no documentation of radiologic evidence of progression, and the patient discontinued for 'Disease progression' due to documented clinical deterioration of disease, the date of discontinuation was used as date of progression.

    TTP was estimated using the Kaplan-Meier method. 95% CI of median was calculated according to Brookmeyer and Crowley method.

    Measured: Up to approximately 33 months

  2. Overall Response Rate (ORR) Based on Investigator's Assessment (Core Phase)

    Overall response rate (ORR) is defined as the percentage of participants with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 based on investigator's assessment.

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

    95% CI was calculated using the exact binomial method.

    Measured: Up to approximately 33 months

  3. Clinical Benefit Rate (CBR) Based on Investigator's Assessment (Core Phase)

    Clinical benefit rate (CBR) is defined as the percentage of participants with a best overall response of complete response (CR), or partial response (PR) or an overall lesion response of stable disease (SD), lasting as per local review, for a duration of at least 24 weeks. CR, PR and SD are defined according to RECIST 1.1 based on investigator's assessment.

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

    SD: Neither sufficient shrinkage to qualify for PR or CR nor an increase in lesions which would qualify for progressive disease.

    95% CI was calculated using the exact binomial method.

    Measured: Up to approximately 33 months

  4. Change From Baseline in Functional Assessment of Cancer Therapy - Breast (FACT-B) Score (Core Phase)

    Change from baseline in FACT-B scores was assessed. FACT-B is a self-report instrument that measures multidimensional quality of life (QOL) in patients with breast cancer. The FACT-B consists of 37 questions that address physical, social, emotional, and functional well-being, with specific questions relevant to women with breast cancer. Each item has a score range of 0 (Not at all) to 4 (Very much), with a total score ranging from 0-148. The higher the score, the better the QOL reported by the participant. A positive change from baseline indicates improvement in QoL.

    Due to the nature of the questionnaire, only females were asked to complete this questionnaire.

    Measured: 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

  5. Number of Participants With AEs and SAEs in the Extension 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.

    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.

    Measured: From first dose of treatment in the Extension phase up to 30 days after last dose of treatment, assessed up approximately 37.6 months

  6. Number of Participants With Clinical Benefit (Extension Phase)

    Clinical benefit as assessed by the Investigator during Extension phase

    Measured: On Day 1 of every 3 cycles, starting from Cycle 1 of the Extension phase until end of treatment, assessed up to 37.4 months. Cycle= 28 days

Timeline

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

  1. First posted21 Oct 2016 (estimated)
  2. Study start30 Nov 2016
  3. Primary completion8 Nov 2019
  4. Study completion9 Nov 2022

Resources

More details

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

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
3,246 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02941926
Sponsor's protocol ID
CLEE011A2404
Other IDs
2016-003467-19, 2016
Acronym
COMPLEEMENT-1
Status last verified
Oct 2023
First submitted
20 Oct 2016
Last updated
24 Oct 2023
Data monitoring committee
No
FDA-regulated drug
Yes
Individual data sharing
Yes: Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. This trial data availability is according to the criteria and process described on https://www.clinicalstudydatarequest.com/.

Publications

  • 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.

    PubMed 36267663

  • 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.

    PubMed 36206609

  • 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.

    PubMed 36152144

  • 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.

    PubMed 35212906

  • 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.

    PubMed 34414532

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