Study of ribociclib combined with hormone therapy for patients with early-stage hormone receptor-positive, HER2-negative breast cancer

3 1 1 1

What is this study about?

This clinical trial focuses on treating early breast cancer that is hormone receptor-positive and HER2-negative. The study evaluates the effectiveness and safety of using ribociclib (also known as LEE011) in combination with hormone therapy. The hormone therapy medications used in the study include anastrozole, letrozole, and goserelin.

The main purpose of this study is to determine if adding ribociclib to standard hormone therapy improves outcomes for patients with early breast cancer compared to hormone therapy alone. Ribociclib is given as a tablet that is taken by mouth, while goserelin is given as an injection under the skin. Anastrozole and letrozole are also taken as tablets.

During the study, patients will receive either the combination of ribociclib with hormone therapy or hormone therapy by itself. The treatment continues for up to 5 years, and patients will have regular check-ups to monitor their health. The study team will track how long patients remain free from cancer returning and assess the overall safety of the treatment combination.

1 Initial medical assessment

Your medical condition will be confirmed as hormone receptor-positive, HER2-negative early breast cancer

Basic health tests will be performed including blood tests, heart function (ECG), and kidney function assessment

2 Treatment assignment

You will be randomly assigned to one of two treatment groups

Group 1: endocrine therapy alone

Group 2: ribociclib plus endocrine therapy

3 Treatment period

The treatment will continue for 5 years from the start date

Depending on your group, you will receive:

– Endocrine therapy: oral medications (anastrozole or letrozole)

– If applicable, goserelin will be given as an injection under the skin

– If assigned, ribociclib will be taken by mouth

4 Regular monitoring

Regular health checks will include:

Blood tests to monitor cell counts and organ function

Heart monitoring with ECG

Physical examinations

Quality of life assessments

5 Follow-up period

The study will continue until April 2026

Regular check-ups will monitor your health status

Assessment of how well the treatment is working

Monitoring for any side effects

Who Can Join the Study?

  • Must be at least 18 years old
  • Must sign an informed consent form before any study procedures
  • Must have completed radiation therapy (if required) before screening
  • Must be able to receive hormone therapy for at least 5 years
  • Must have good physical functioning status (ECOG 0 or 1, meaning able to perform daily activities)
  • Must have adequate blood test results, including:
    • Normal white blood cell counts
    • Normal platelet levels
    • Adequate hemoglobin levels
    • Normal kidney function
    • Normal liver function
  • Must have normal heart rhythm on ECG test
  • Must be willing to attend all scheduled visits and follow study procedures
  • Women who can become pregnant must have a negative pregnancy test and use effective birth control methods during the study
  • Must have confirmed breast cancer that is:
    • Hormone receptor-positive (responds to hormones)
    • HER2-negative (specific type of breast cancer)
    • Completely removed by surgery with clear margins
    • At specific disease stages (Stage IIA, IIB, or III) with certain risk factors
  • Must have completed chemotherapy (if required) before screening
  • Must have tumor tissue available for laboratory testing (except for patients in China)

Who Cannot Join the Study?

  • Previous treatment with CDK4/6 inhibitors (drugs that block specific proteins involved in cell growth)
  • Presence of metastatic disease (cancer that has spread to other parts of the body)
  • History of other malignancies within the past 5 years, except for adequately treated non-melanoma skin cancer or carcinoma in situ
  • Severe heart conditions including:
    • Uncontrolled high blood pressure
    • Heart attack within past 6 months
    • Unstable heart rhythm problems
  • Severe liver problems or abnormal liver function tests
  • Known hypersensitivity (allergic reaction) to the study medications
  • Pregnant or breastfeeding women
  • Participation in another clinical trial within 30 days before starting this study
  • Any condition that would make it unsafe for the patient to participate in the study, as determined by the study doctor
  • Unable to swallow oral medications
  • Major surgery within 14 days before starting the study treatment
  • Active or uncontrolled infections

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Cliniques Universitaires Saint-Luc Woluwe-Saint-Lambert Belgium
Centre Antoine Lacassagne Nice France
Centre Hospitalier Victor Dupouy Argenteuil France
Hopitaux Universitaires Pitie Salpetriere Paris France
Hopital Tenon Paris France
Institut Jules Bordet Anderlecht Belgium
IRCCS Humanitas Research Hospital Rozzano Italy
Hospital Vall d’Hebron Barcelona Spain
Beaumont Hospital Dublin Ireland
Hospital Universitario da A Coruna A Coruna Galicia Spain
Virgen del Rocío University Hospital Sevilla Spain
Universitaetsklinikum Erlangen AöR Erlangen Germany
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Medical University Of Vienna Vienna Austria
Hospital Clinic De Barcelona Barcelona Spain
Center For Pediatric And Adolescent Medicine Of The Johannes Gutenberg University Mainz Mainz Germany
Hospital Universitario Fundacion Jimenez Diaz Madrid Spain
University Clinical Hospital Virgen De La Arrixaca Murcia Spain
Universita’ Politecnica Delle Marche Ancona Italy
Hospital Universitario De Salamanca Salamanca Spain
Hospital General Universitario De Valencia Valencia Spain
Hospital Clinico San Carlos Madrid Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Universitaetsklinikum Muenster AöR Munster Germany
Jessa Ziekenhuis Hasselt Belgium
Gasthuiszusters Antwerpen Antwerp Belgium
Centre Hospitalier Universitaire De Nantes Nantes France
Klinikum der Universitaet Muenchen AöR Munich Germany
University Of Szeged Szeged Hungary
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
St Vincent’s University Hospital Dublin Ireland
Medizinische Universitaet Innsbruck Innsbruck Austria
University Of Antwerp Edegem Belgium
Klinikum der Technischen Universitaet Muenchen (TUM Klinikum) Munich Germany
Azienda Ospedaliera Papa Giovanni XXIII Bergamo Italy
Universitaetsklinikum Essen AöR Essen Germany
Institut Gustave Roussy Villejuif France
IRCCS Istituto Nazionale Tumori Fondazione Pascale Naples Italy
I.F.O. Istituti Fisioterapici Ospitalieri Rome Italy
Oncopole Claudius Regaud Toulouse France
Centr Georges Francois Leclerc Dijon France
Technische Universitaet Dresden Dresden Germany
Ordensklinikum Linz GmbH Linz Austria
Centre hospitalier universitaire de Liege Liege Belgium
Katholieke Universiteit te Leuven Leuven Belgium
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH Ulm Germany
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Centre Hospitalier Lyon Sud Pierre Benite France
Hospital General Universitario Gregorio Maranon Madrid Spain
Hopital Beaujon Clichy France
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Vrije Universiteit Brussel Jette Belgium
Institut Catala D’oncologia L'hospitalet De Llobregat Spain
Centrum Onkologii Ziemi Lubelskiej Im. Sw. Jana Z Dukli Lublin Poland
Fundacion Instituto Valenciano De Oncologia Valencia Spain
Hospital Clinico Universitario Lozano Blesa Zaragoza Spain
Complexo Hospitalario Universitario De Vigo Vigo Spain
Hospital Universitario Virgen De Las Nieves Granada Spain
Hospital Universitario De Navarra Pamplona Spain
Institut Curie – Site Paris Paris France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Hospital Universitario Virgen De La Victoria Malaga Spain
Parc Tauli Hospital Universitari Sabadell Spain
Institut Regional Du Cancer De Montpellier Montpellier France
Institut De Cancerologie Strasbourg Europe STRASBOURG, Alsace France
Centre Henri Becquerel Rouen France
Institut De Cancerologie De Lorraine Vandoeuvre Les Nancy France
Centrul De Oncologie SF Nectarie S.R.L. Craiova Romania
Tolna Vármegyei Balassa János Kórház Szekszard Hungary
CHU Croix Rousse-Lyon Lyon France
Bacs-Kiskun Varmegyei Oktatokorhaz Kecskemet Hungary
Clinique Victor Hugo Le Mans France
Spitalul Clinic Filantropia Bucharest Romania
Centre Francois Baclesse Caen France
Centre De Lutte Contre Le Cancer Eugene Marquis Rennes France
Centre Hospitalier Et Universitaire De Limoges Limoges France
Universitaetsklinikum Regensburg AöR Regensburg Germany
Assistance Publique Hopitaux De Paris Paris France
Comite Entreprise Paul Papin Angers France
Istituto Di Candiolo Fondazione Del Piemonte Per Loncologia IRCCS Candiolo Italy
Besancon University Hospital Center Besançon France
Hospital Femme Mere Enfant Bron France
Hospital Universitario Araba Vitoria Spain
Gynaekologisches Zentrum Bonn Bonn Germany
Zala Megyei Szent Rafael Korhaz Zalaegerszeg Hungary
Hospital Universitario Donostia Donostia / San Sebastian Spain
Hospital Universitario Lucus Augusti Lugo Spain
Institute Of Oncology Prof. Dr. Ion Chiricuta Cluj-Napoca Cluj Napoca Romania
Hopital Saint Joseph Marseille France
Narodowy Instytut Onkologii Im. Marii Sklodowskiej-Curie-Panstwowy Instytut Badawczy Cracow Poland
University Of Pecs Pecs Hungary
Hospital Universitario De Canarias La Laguna Spain
Centro Di Riferimento Oncologico Di Aviano Aviano Italy
Centre Hospitalier Regional De La Citadelle Liege Belgium
Hospital General Universitario Morales Meseguer Murcia Spain
Cork University Hospital Cork Ireland
University Hospital Limerick Limerick Ireland
Hospital San Pedro De Alcantara Caceres Spain
Area De Salud De Burgos Y Soria Burgos Spain
Grand Hopital De Charleroi Charleroi Belgium
University Hospital Waterford Waterford Ireland
Dolnoslaskie Centrum Onkologii Pulmonologii I Hematologii Wroclaw Poland
Hospital Universitario De Jaen Jaen Spain
Hospital Universitario Basurto Bilbao Spain
Consorcio Hospitalario Provincial De Castellon Castello De La Plana Spain
El Hospital Universitario De Gran Canaria Dr. Negrin Las Palmas De Gran Canaria Spain
Hospital Universitario De Fuenlabrada Fuenlabrada Spain
Kliniken Essen-Mitte,Evangelische Huyssens-Stiftung Essen Germany
Eb Haus Austria Gemeinnuetzige Salzburger Landeskliniken Betriebsgesellschaft mbH Salzburg Austria

Other Sites

Site Name City Country Status
Rotkreuzklinikum Muenchen gGmbH Munich Germany
Haematologie-Onkologie im Zentrum MVZ GmbH Augsburg Germany
MVZ Onko Medical GmbH Hannover Hanover Germany
L’Hopital Prive Du Confluent Nantes France
Mater Private Hospital Dublin Ireland
Centre De Cancerologue Du Grand Montpellier Montpellier France
Institut Sainte Catherine Avignon France
Europejskie Centrum Zdrowia Otwock Sp. z o.o. Otwock Poland
Medizinischen Universität Lausitz – Carl Thiem Cottbus Germany
Flkwiaguuc Hornsfej Hueuqplrwj Georgsmarienhütte Germany
Btfdiqfnv Uaoxbq Urtxh Kozmkn Budapest Hungary
Cstmps Oinrzwtdwi Db Geqmpxm A Coruna Galicia Spain
Ubigtwhnrsmoxvixkkhqc Mygqmbps Gmns Mannheim Germany
Mbdooyyybgzmvw Byklltz gtdem Bottrop Germany
Hgkwcm Kqbuuznx Bqbstnygpml Gkqp Berlin Germany
Cppjoq Hfnhzmarkru Uzcfykvjbbjtt Dxmknj Gmhrndi Shrzvyrcvcfmaqouogmgxawsfd Namur Belgium
Spltjcqp Plsewkftb Svg z ovwc Gdynia Poland
Udmsatswat Tzfdfzlu Hlmyjmmp Mwtkbkxytcrv Szombathely Hungary
Mvvwwtwcsb Sohqcfa Sivearmtigrfoju Ibpnzxsegnfj Pjwmiqnzmo W Oamtzwowc Ostroleka Poland
Shiklwuhves Kmqtjnx Kivh Debrecen Hungary
Crumdfci dd lafvcbtunnkqza Amiens France
Anuuwqztlk Fiktasippfx Duxskkle Kwcimmoe gafqf Frankfurt Germany
Oxqlzagab Rgmrpmtsi Pprhyrbmgnsqae Troisdorf Germany
Okojcfe Sixssl Timisoara Romania
Lvncwltyhjdwkhhuesyvjp dzw Svjcm Sbjavqubxaw Gili Schweinfurt Germany
Hitpulax Urgjsotypfbgg Dh Bhjnybi Badajoz Spain
Ofoydhaq Crcqrbk Ooklstjsu Icv Pagnq Tvzhgagq Kvixgbdunumfgd W Ohfig Seeawgepqbm Pxrllqyal Zveexi Okqded Ztnftssiza Opole Poland
Ogyvjwk Sszbpq Craiova Romania
Hvgtgjgfs Iaettugm Cammnkz Culjzavs Shadlt Misterbianco Italy
Usnda Mhg Gfcbrxk Gedgux Huvj Mqdftidtnp Dv Galrwhpb Grenoble France
Kcsfyagbxuejxabql Vmmgdfuwu Smoud Bhnzzcn Kxzyzw Tatabanya Hungary
Sexomrzxivozmi Ojjofsmfh Rmutygrqog Gbbh Ravensburg Germany
Hxaaoiu Dg Lkfvkndtf Libramont-Chevigny Belgium
Cxoaweh Thkgkya Wjcqksftkcnd Jmzu Jomwygtzxwyi Ssqvip Lodz Poland
Mr Arytpqgb Clsgsg Cqdigi Madrid Spain
Beptjtrnleic Cayzarm Orailpvzj Idr Mdaxf Ssfqvxpekidxzjnkoy W Bzcwwcddznh Bialystok Poland
Mvpugnmaiw Scikvlo Oqfrhafnjjhb Slt z ovyz Wieliszew Poland
Rzjaclzpjc Snirrwr Sloxowmymqfdpyd Iwg Dyx Wlsoqswomg Bkototxbxecj Grudziadz Poland
Acurzmm Xyebr Anjlaaulzqgf Uxdbmilkeuzzg Dj Mlsxaya Fxkxrfid Papstzq Manresa Spain
Meccwjabkqtz Hldqept Maf Gjf Hamburg Germany
Bzoelszrnxzm Rlopfrweab Sdkxgehynmjeqlrlofg mxw Moenchengladbach Germany
Mqhhzejxjjeuj Vzuuluw Gnq Velbert Germany
Shuef Mohddu Ksnjzy Budapest Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
14.06.2019
Belgium Belgium
Not recruiting
14.06.2019
France France
Not recruiting
14.06.2019
Germany Germany
Not recruiting
14.06.2019
Hungary Hungary
Not recruiting
14.06.2019
Ireland Ireland
Not recruiting
14.06.2019
Italy Italy
Not recruiting
14.06.2019
Poland Poland
Not recruiting
14.06.2019
Romania Romania
Not recruiting
14.06.2019
Spain Spain
Not recruiting
14.06.2019

Trial locations

Ribociclib
A medication used in combination with endocrine therapy for treating breast cancer. It belongs to a class of drugs called CDK4/6 inhibitors that help stop cancer cells from growing and dividing. This medication is taken orally and works by blocking specific proteins that promote cancer cell growth.

Endocrine Therapy (ET)
A treatment that blocks or lowers the amount of hormones in the body to stop or slow down the growth of hormone receptor-positive breast cancer. This therapy can include different types of hormone-blocking medications that either lower estrogen levels or prevent estrogen from attaching to cancer cells.

Hormone Receptor-Positive Breast Cancer – A type of breast cancer where cancer cells grow in response to hormones estrogen and progesterone. The cancer cells have proteins called hormone receptors that become activated when hormones attach to them. This disease typically develops in the breast tissue and can spread to nearby lymph nodes. The cancer cells display specific receptors on their surface that respond to natural hormones in the body. This condition represents the most common form of breast cancer.

HER2-Negative Breast Cancer – A form of breast cancer where the cancer cells do not have high amounts of a protein called HER2 on their surface. This cancer tends to grow more slowly than HER2-positive cancers. The disease develops when breast cells begin to divide uncontrollably without elevated levels of the HER2 protein. This type of breast cancer typically responds differently to treatments compared to HER2-positive cases.

Early Breast Cancer – A stage of breast cancer where the disease is contained within the breast or has only spread to nearby lymph nodes. At this stage, the cancer is localized and has not spread to distant parts of the body. The disease is typically discovered during early screening or when a small lump is detected. This represents the initial phase of breast cancer development.

Trial ID:
2023-510357-42-00
Protocol code:
CLEE011O12301C
NCT ID:
NCT03701334
Trial Phase:
Therapeutic confirmatory (Phase III)

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