Breast Cancer Clinical Trial

A Trial to Evaluate Efficacy and Safety of Ribociclib With Endocrine Therapy as Adjuvant Treatment in Patients With HR+/HER2- Early Breast Cancer

Summary

A phase III multi-center, randomized, open-label trial to evaluate efficacy and safety of ribociclib with endocrine therapy as adjuvant treatment in patients with HR+/HER2- Early Breast Cancer

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Full Description

The trial will include pre and postmenopausal women and men with HR-positive, HER2-negative EBC, with an Anatomic Stage Group III, IIB or a subset of Stage IIA cases, after adequate surgical resection, radiotherapy (if indicated), adjuvant or neoadjuvant chemotherapy (if indicated), and who are deemed to be eligible for adjuvant ET for at least 60 months of duration.

Approximately 5,000 patients will be randomized (using an Interactive Response Technology system [IRT]) into two treatment arms in a 1:1 ratio.

The trial will include screening, treatment, and follow up phases.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Patient is ≥ 18 years-old at the time of PICF signature
Patient is female with known menopausal status at the time of randomization or initiation of adjuvant ET (whichever occurs earlier), or male.
Patient with histologically confirmed unilateral primary invasive adenocarcinoma of the breast with a date of initial cytologic or histologic diagnosis within 18 months prior to randomization.
Patient has breast cancer that is positive for ER and/or PgR
Patient has HER2-negative breast cancer
Patient has available archival tumor tissue from the surgical specimen
Patient after surgical resection where tumor was removed completely, with the final surgical specimen microscopic margins free from tumor, and belongs to one of the following categories: anatomic stage group II or III
If indicated, patient has completed adjuvant and/or neoadjuvant chemotherapy according to the institutional guidelines
If indicated, patient has completed adjuvant radiotherapy according to the institutional guidelines
Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1.
Patient has no contraindication for the adjuvant ET in the trial and is planned to be treated with ET for 5 years

Exclusion Criteria:

Patient has received any CDK4/6 inhibitor
Patient has received prior treatment with tamoxifen, raloxifene or AIs for reduction in risk ("chemoprevention") of breast cancer and/or treatment for osteoporosis within the last 2 years prior to randomization. Patient is concurrently using hormone replacement therapy.
Patient has received prior treatment with anthracyclines at cumulative doses of 450 mg/m² or more for doxorubicin, or 900 mg/m² or more for epirubicin.
Patient with a known hypersensitivity to any of the excipients of ribociclib and/or ET
Patient with distant metastases of breast cancer beyond regional lymph nodes (stage IV according to AJCC 8th edition) and/or evidence of recurrence after curative surgery.
Patient is concurrently using other anti-neoplastic therapy with the exception of adjuvant ET
Patient has had major surgery, chemotherapy or radiotherapy within 14 days prior to randomization
Patient has not recovered from clinical and laboratory acute toxicities related to prior anti-cancer therapies
Patient has a concurrent invasive malignancy or a prior invasive malignancy whose treatment was completed within 2 years before randomization
Patient has known HIV infection, Hepatitis B or C infection
Clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality
Patient is currently receiving any of the following substances within 7 days before randomization - Concomitant medications, herbal supplements, and/or fruits that are known as strong inhibitors or inducers of CYP3A4/5 or Medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5
is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting trial treatment
Patient has impairment of GI function or GI disease that may significantly alter the absorption of the oral trial treatments
Patient has any other concurrent severe and/or uncontrolled medical condition that would, in the Investigator's judgment, cause unacceptable safety risks, contraindicate patient participation in the clinical trial or compromise compliance with the protocol
Participation in other studies involving investigational drug(s) within 30 days prior to randomization or within 5 half-lives of the investigational drug(s) (whichever is longer), or participation in any other type of medical research judged not to be scientifically or medically compatible with this trial.
Pregnant or breast-feeding (lactating) women or women who plan to become pregnant or breast-feed during the trial

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

5101

Study ID:

NCT03701334

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 381 Locations for this study

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University of Alabama at Birmingham/ Kirklin Clinic
Birmingham Alabama, 35294, United States
Cancer Treatment Centers of America
Goodyear Arizona, 85338, United States
St Bernards Medical Center
Jonesboro Arkansas, 72401, United States
Comprehensive Blood and Cancer Center SC-2
Bakersfield California, 93309, United States
UCLA Beverly Hills
Beverly Hills California, 90212, United States
UCLA Burbank
Burbank California, 91505, United States
Encino Research Center
Encino California, 91436, United States
UCLA Hematology Oncology
Laguna Hills California, 92653, United States
Southern California Oncology Research Alliance SCORA
Los Angeles California, 90057, United States
Valley Breast Care and Women s Health Center
Los Angeles California, 91405, United States
Stanford University Medical Center
Palo Alto California, 94304, United States
UCLA Pasadena Health Care Hematology Oncology
Pasadena California, 94110, United States
UCLA Porter Ranch Hematology and Oncology
Porter Ranch California, 91326, United States
Cancer Care Associates Medical Group
Redondo Beach California, 90277, United States
Sharp Memorial Hospital Regulatory
San Diego California, 92123, United States
University of California San Francisco Gynecologic Oncology
San Francisco California, 94115, United States
Central Coast Medical Oncology Corporation Onc Dept
Santa Maria California, 93454, United States
UCLA Santa Monica Hematology / Oncology Regulatory-2
Santa Monica California, 90404, United States
Lundquist Inst BioMed at Harbor
Torrance California, 90509, United States
UCLA Valencia
Valencia California, 91355, United States
UCLA Cancer Center, Westlake Village
Westlake Village California, 91361, United States
St. Jude Heritage Medical Group Dept.of Virginia K Crosson Ctr
Yorba Linda California, 92886, United States
University of Colorado Hospital
Aurora Colorado, 80045, United States
Rocky Mountain Cancer Centers
Greenwood Village Colorado, 80501, United States
Hospital of Central Connecticut
New Britain Connecticut, 06052, United States
Yale University School of Medicine
New Haven Connecticut, 06520, United States
Norwalk Hospital Pulmonary Medicine
Norwalk Connecticut, 06856, United States
Eastern Connecticut Hematology and Oncology Associates Regulatory
Norwich Connecticut, 06360, United States
Holy Cross Hospital - Ft. Lauderdale CLCZ696BUS01
Fort Lauderdale Florida, 33308, United States
Florida Cancer Specialists
Fort Myers Florida, 33901, United States
Memorial Cancer Institute
Hollywood Florida, 33021, United States
Baptist MD Anderson Cancer Center
Jacksonville Florida, 32207, United States
University of Miami
Miami Florida, 33136, United States
Orlando Health, Clinical Trials Orlando Health Inc
Orlando Florida, 32806, United States
Florida Cancer Specialists-North
Saint Petersburg Florida, 33705, United States
Florida Cancer Specialists Panhandle
Tallahassee Florida, 32308, United States
Florida Cancer Specialists- East Region
West Palm Beach Florida, 33401, United States
Winship Cancer Institute of Emory University
Atlanta Georgia, 30322, United States
Southeastern Regional Medical Center
Newnan Georgia, 30265, United States
Cancer Treatment Centers of America
Zion Illinois, 60099, United States
Cancer Care Center
New Albany Indiana, 47150, United States
University of Kansas Cancer Center
Westwood Kansas, 66205, United States
Cancer Center of Kansas
Wichita Kansas, 67214, United States
Norton Cancer Institute
Louisville Kentucky, 40202, United States
Mercy Medical Center
Baltimore Maryland, 21202, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
University of Michigan Cancer Center
Ann Arbor Michigan, 48109, United States
Fairview Health Services
Maple Grove Minnesota, 55369, United States
Metro Minnesota CCOP Metro Minneapolis CCOP
Saint Louis Park Minnesota, 55416, United States
Park Nicollet Institute
Saint Louis Park Minnesota, 55416, United States
Saint Luke's Hospital of Kansas City
Kansas City Missouri, 64111, United States
HCA Midwest Division
Kansas City Missouri, 64132, United States
David C Pratt Cancer Center
Saint Louis Missouri, 63141, United States
St Vincent Frontier Cancer Center
Billings Montana, 59102, United States
Saint Francis Medical Center
Grand Island Nebraska, 68803, United States
Comprehensive Cancer Centers of Nevada
Las Vegas Nevada, 89109, United States
Saint Barnabas Medical Center
Livingston New Jersey, 07039, United States
Perlmutter Cancer Centre
New York New York, 10016, United States
Randolph Medical Associates
Asheboro North Carolina, 27204, United States
Alamance Regional Medical Cancer Center
Burlington North Carolina, 27215, United States
Cone Health Cancer Center
Greensboro North Carolina, 27403, United States
Kaiser Permanente NW Region
Clackamas Oregon, 97015, United States
Penn State Hershey Cancer Institute
Hershey Pennsylvania, 17033, United States
Cancer Treatment Centers of America Eastern Regional Medical Center
Philadelphia Pennsylvania, 19124, United States
The West Clinic
Germantown Tennessee, 38138, United States
Sarah Cannon Research Institute
Nashville Tennessee, 37203, United States
Baylor Charles A. Sammons Cancer Center
Dallas Texas, 75246, United States
Center for Cancer and Blood Disorders Research Department
Fort Worth Texas, 76104, United States
MD Anderson Cancer Center/University of Texas
Houston Texas, 77030, United States
Utah Cancer Specialists
Salt Lake City Utah, 84106, United States
Virginia Cancer Specialists
Fairfax Virginia, 22031, United States
Virginia Cancer Institute
Richmond Virginia, 23230, United States
Seattle Cancer Care Alliance Medical Oncology
Seattle Washington, 98109, United States
University of Wisconsin / Paul P. Carbone Comp Cancer Center
Madison Wisconsin, 53792, United States
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Rosario Santa Fe, S2000, Argentina
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Rosario Sante Fe, S200K, Argentina
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San Miguel De Tucuman Tucuman, T4000, Argentina
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Rio Negro Viedma, 8500, Argentina
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Caba , C1419, Argentina
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Cordoba , X5004, Argentina
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Jujuy , 4600, Argentina
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Campbelltown New South Wales, 2560, Australia
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Darlinghurst New South Wales, 2010, Australia
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Kingswood New South Wales, 2747, Australia
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Kogarah New South Wales, 2217, Australia
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Liverpool New South Wales, 2170, Australia
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North Ryde New South Wales, 2109, Australia
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St Leonards New South Wales, 2065, Australia
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Wahroonga New South Wales, 2076, Australia
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Westmead New South Wales, 2145, Australia
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Auchenflower Queensland, 4066, Australia
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Birtinya Queensland, 4575, Australia
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Wooloongabba Queensland, 4102, Australia
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Bedford Park South Australia, 5042, Australia
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Bendigo Victoria, 3550, Australia
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East Melbourne Victoria, 3002, Australia
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Epping Victoria, 3076, Australia
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Fitzroy Victoria, 3065, Australia
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Franston Victoria, 3199, Australia
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Heidelberg Victoria, 3084, Australia
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Melbourne Victoria, 3000, Australia
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Shepparton Victoria, 3630, Australia
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Murdoch Western Australia, 6150, Australia
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Nedlands Western Australia, 6009, Australia
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Graz Styria, 8036, Austria
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Innsbruck Tyrol, 6020, Austria
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Linz , 4020, Austria
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Salzburg , 5020, Austria
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Wien , 1090, Austria
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Edegem Antwerpen, 2650, Belgium
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Bruxelles , 1000, Belgium
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Bruxelles , 1090, Belgium
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Bruxelles , 1200, Belgium
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Charleroi , 6000, Belgium
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Hasselt , 3500, Belgium
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Leuven , 3000, Belgium
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Libramont , 6800, Belgium
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Liege , 4000, Belgium
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Namur , 5000, Belgium
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Wilrijk , 2610, Belgium
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Yvoir , 5530, Belgium
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Londrina PR, 86015, Brazil
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Porto Alegre Rio Grande Do Sul, 90050, Brazil
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Porto Alegre Rio Grande Do Sul, 90610, Brazil
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Ijuí RS, 98700, Brazil
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Porto Alegre RS, 90035, Brazil
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Porto Alegre RS, 90560, Brazil
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Porto Alegre RS, 90880, Brazil
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Barretos Sao Paulo, 14784, Brazil
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Santo Andre SP, 09060, Brazil
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Sao Paulo SP, 01317, Brazil
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Sao Paulo SP, 03102, Brazil
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Caxias do Sul , 95070, Brazil
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Passo Fundo , 99010, Brazil
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Piracicaba , 13419, Brazil
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Recife , 50040, Brazil
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Rio De Janeiro , 20560, Brazil
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Salvador , 41810, Brazil
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Sao Paulo , 01255, Brazil
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Calgary Alberta, T2N 4, Canada
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Edmonton Alberta, T6G 1, Canada
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Kelowna British Columbia, V1Y 5, Canada
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North Vancouver British Columbia, V7L 2, Canada
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Surrey British Columbia, V3V 1, Canada
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Vancouver British Columbia, V5Z 4, Canada
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Halifax Nova Scotia, B3H 1, Canada
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Kitchener Ontario, N2G 1, Canada
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London Ontario, N6A 4, Canada
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Newmarket Ontario, J7Y 2, Canada
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Oshawa Ontario, L1G 2, Canada
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Sault Ste Marie Ontario, P6B 0, Canada
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Sudbury Ontario, P3E 5, Canada
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Toronto Ontario, M4N 3, Canada
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Toronto Ontario, M5G 2, Canada
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Windsor Ontario, N8W 2, Canada
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Greenfield Park Quebec, J4V 2, Canada
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Montreal Quebec, H2W 1, Canada
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Montreal Quebec, H4A 3, Canada
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Sherbrooke Quebec, J1H 5, Canada
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St-Jerome Quebec, J7Z 5, Canada
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Shijiazhuang Hebei, 05001, China
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Harbin Heilongjiang, 15008, China
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Zhengzhou Henan, 45000, China
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Wuhan Hubei, 43002, China
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Suzhou Jiangsu, 21500, China
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Chang Chun Jilin, 13002, China
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Chengdu Sichuan, 61004, China
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Tianjin Tianjin, 30006, China
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Hangzhou Zhejiang, 31001, China
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Beijing , 10002, China
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Chongqing , 40001, China
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Guangzhou , 51000, China
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Nanjing , 21003, China
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Shanghai , 20003, China
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Zhenjiang , , China
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Nice Cedex 2 Alpes Maritimes, 06189, France
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Dijon Cedex Cote D Or, 21034, France
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Limoges cedex Haute Vienne, 87000, France
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Saint-Cloud Hauts De Seine, 92210, France
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Rennes Cedex Ille Et Vilaine, 35062, France
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Amiens , 80000, France
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Angers Cedex 02 , 49055, France
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Argenteuil , 95107, France
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Avignon Cedex , 84082, France
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Besancon cedex , 25030, France
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Bordeaux Cedex , 33076, France
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Caen Cedex , 14021, France
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Grenoble cedex , 38028, France
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Le Mans , 72000, France
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Lyon , 69317, France
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Lyon , 69677, France
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Marseille , 13008, France
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Montpellier Cedex 5 , 34298, France
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Montpellier , 34070, France
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Nantes cedex 2 , 44202, France
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Paris Cedex 10 , 75475, France
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Paris Cedex 13 , 75651, France
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Paris , 75015, France
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Paris , 75231, France
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Paris , 75970, France
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Pierre Benite Cedex , 69495, France
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Rouen Cedex 1 , 76038, France
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Saint Herblain cedex , 44805, France
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Strasbourg , F 670, France
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Toulouse Cedex 9 , 31059, France
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Vandoeuvre-les-Nancy cedex , 54519, France
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Villejuif Cedex , 94800, France
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Ravensburg Baden-Wuerttemberg, 88212, Germany
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Muenchen Bavaria, 80637, Germany
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Georgsmarienhuette Lower Saxony, 49124, Germany
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Hannover Niedersachsen, 30177, Germany
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Essen Nordrhein-Westfalen, 45136, Germany
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Velbert North Rhine-westphalia, 42551, Germany
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Augsburg , 86150, Germany
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Bad Liebenwerda , 04924, Germany
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Berlin , 13125, Germany
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Bonn , 53111, Germany
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Bottrop , 46236, Germany
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Cottbus , 03048, Germany
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Dresden , 01307, Germany
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Erlangen , 91054, Germany
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Essen , 45147, Germany
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Frankfurt , 60431, Germany
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Hamburg , 20357, Germany
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Kiel , 24105, Germany
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Mainz , 55131, Germany
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Mannheim , 68167, Germany
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Moenchengladbach , 41061, Germany
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Muenchen , 81377, Germany
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Muenster , 48149, Germany
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Munchen , 81675, Germany
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Regensburg , 93053, Germany
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Schweinfurt , 97422, Germany
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Tübingen , 72076, Germany
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Ulm , 89081, Germany
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Wuerzburg , 97080, Germany
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Zalaegerszeg Zala, 8900, Hungary
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Budapest , 1085, Hungary
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Budapest , 1145, Hungary
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Budapest , H-103, Hungary
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Debrecen , 4032, Hungary
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Kecskemet , 6000, Hungary
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Szeged , 6725, Hungary
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Szombathely , 9700, Hungary
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Wilton Cork, , Ireland
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Bergamo BG, 24127, Italy
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Catania CT, 95123, Italy
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Milano MI, 20133, Italy
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Rozzano MI, 20089, Italy
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Palermo PA, 90146, Italy
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Aviano PN, 33081, Italy
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Roma RM, 00128, Italy
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Candiolo TO, 10060, Italy
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Cheongju si Chungcheongbuk Do, 28644, Korea, Republic of
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Bundang Gu Gyeonggi Do, 13620, Korea, Republic of
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Seoul , 06351, Korea, Republic of
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Ulsan , 44033, Korea, Republic of
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Bialystok , 15 02, Poland
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Gdynia , 81 51, Poland
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Gliwice , 44 10, Poland
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Grudziadz , 86 30, Poland
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Opole , 45 05, Poland
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Ostroleka , 07 41, Poland
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Otwock , 05 40, Poland
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Wieliszew , 05 13, Poland
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Wroclaw , 53 41, Poland
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Craiova Dolj, 20034, Romania
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Craiova Dolj, 20053, Romania
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Bucuresti , 01117, Romania
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Cluj-Napoca , 40012, Romania
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Timisoara , 30023, Romania
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Leningrad Region Russia, 18866, Russian Federation
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St Petersburg Saint Petersburg, 19527, Russian Federation
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Chelyabinsk , 45408, Russian Federation
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Kazan , 42002, Russian Federation
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Kostroma , 15600, Russian Federation
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Krasnoyarsk , 66002, Russian Federation
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Moscow , 11112, Russian Federation
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Moscow , 11547, Russian Federation
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Moscow , 14342, Russian Federation
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Nizhny Novgorod , 60313, Russian Federation
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Novosibirsk , , Russian Federation
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Obninsk , 24903, Russian Federation
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Omsk , 64401, Russian Federation
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Orenburg , 46002, Russian Federation
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Rostov-na-Donu , 34403, Russian Federation
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Ryazan , 39001, Russian Federation
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St Petersburg , 19775, Russian Federation
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St- Petersburg , 19702, Russian Federation
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Tyumen , 62504, Russian Federation
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Ufa , 45005, Russian Federation
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Yaroslavl , 15005, Russian Federation
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Elche Alicante, 03203, Spain
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Cordoba Andalucia, 14004, Spain
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Granada Andalucia, 18014, Spain
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Huelva Andalucia, 21005, Spain
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Jaen Andalucia, 23007, Spain
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Sevilla Andalucia, 41017, Spain
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Manresa Catalunya, 08240, Spain
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Barcelona Cataluña, 08907, Spain
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Alicante Comunidad Valenciana, 03550, Spain
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Valencia Comunidad Valenciana, 46010, Spain
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Valencia Comunidad Valenciana, 46014, Spain
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Badajoz Extremadura, 06080, Spain
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Caceres Extremadura, 10003, Spain
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A Coruna Galicia, 15009, Spain
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La Coruna Galicia, 15006, Spain
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Lugo Galicia, 27003, Spain
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Fuenlabrada Madrid, 28942, Spain
Novartis Investigative Site
El Palmar Murcia, 30120, Spain
Novartis Investigative Site
Pamplona Navarra, 31008, Spain
Novartis Investigative Site
San Sebastian Pais Vasco, 20080, Spain
Novartis Investigative Site
Vitoria-Gasteiz País Vasco, 01009, Spain
Novartis Investigative Site
Vigo Pontevedra, 36312, Spain
Novartis Investigative Site
La Laguna Santa Cruz De Tenerife, 38320, Spain
Novartis Investigative Site
Bilbao , 48013, Spain
Novartis Investigative Site
Castellon , 12002, Spain
Novartis Investigative Site
Girona , 17007, Spain
Novartis Investigative Site
Granada , 18013, Spain
Novartis Investigative Site
Las Palmas de Gran Canaria , 35010, Spain
Novartis Investigative Site
Madrid , 28009, Spain
Novartis Investigative Site
Madrid , 28033, Spain
Novartis Investigative Site
Madrid , 28034, Spain
Novartis Investigative Site
Madrid , 28040, Spain
Novartis Investigative Site
Madrid , 28222, Spain
Novartis Investigative Site
Murcia , 30008, Spain
Novartis Investigative Site
Valencia , 46009, Spain
Novartis Investigative Site
Zaragoza , 50009, Spain
Novartis Investigative Site
Changhua , 50006, Taiwan
Novartis Investigative Site
Taichung , 40447, Taiwan
Novartis Investigative Site
Taichung , 407, Taiwan
Novartis Investigative Site
Tainan , 70403, Taiwan
Novartis Investigative Site
Taipei , 10002, Taiwan
Novartis Investigative Site
Taipei , 10449, Taiwan
Novartis Investigative Site
Taipei , 11217, Taiwan
Novartis Investigative Site
Taipei , , Taiwan
Novartis Investigative Site
Taoyuan , 33305, Taiwan
Novartis Investigative Site
Truro Cornwall, TR1 3, United Kingdom
Novartis Investigative Site
Cardiff , CF14 , United Kingdom
Novartis Investigative Site
London , NW1 2, United Kingdom
Novartis Investigative Site
London , SE1 9, United Kingdom
Novartis Investigative Site
London , SM2 5, United Kingdom
Novartis Investigative Site
London , SW3 6, United Kingdom
Novartis Investigative Site
Nottingham , NG5 1, United Kingdom
Novartis Investigative Site
Oxford , OX3 7, United Kingdom
Novartis Investigative Site
Preston , PR2 9, United Kingdom
Novartis Investigative Site
Stoke-on-Trent , ST4 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

5101

Study ID:

NCT03701334

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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