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A Trial to Evaluate Efficacy ...

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

Last Updated: 2025-10-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

5101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-07

Study Completion Date

2026-05-29

Brief Summary

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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 (EBC)

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Detailed Description

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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.

Conditions

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Early Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ribociclib + Endocrine Therapy

Participants will receive ribociclib 400 mg once daily on days 1-21 of a 28-day cycle and endocrine therapy once daily continuously

Group Type EXPERIMENTAL

Ribociclib

Intervention Type DRUG

Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle

Endocrine Therapy

Intervention Type OTHER

ET will be administered according to the local clinical guidelines and current local prescribing information

Endocrine Therapy

Participants will receive endocrine therapy only once daily continuously

Group Type ACTIVE_COMPARATOR

Endocrine Therapy

Intervention Type OTHER

ET will be administered according to the local clinical guidelines and current local prescribing information

Interventions

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Ribociclib

Ribociclib orally taken at 400 mg on days 1 to 21 of a 28-day cycle

Intervention Type DRUG

Endocrine Therapy

ET will be administered according to the local clinical guidelines and current local prescribing information

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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University of Alabama at Birmingham-Kirklin Clinic

Birmingham, Alabama, United States

Site Status

Cancer Treatment Centers of America

Goodyear, Arizona, United States

Site Status

St Bernards Medical Center

Jonesboro, Arkansas, United States

Site Status

Comprehensive Blood and Cancer

Bakersfield, California, United States

Site Status

UCLA Beverly Hills

Beverly Hills, California, United States

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UCLA Burbank

Burbank, California, United States

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Encino Research Center

Encino, California, United States

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St. Jude Heritage Medical Group

Fullerton, California, United States

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UCLA Hematology Oncology

Laguna Hills, California, United States

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Southern CA Oncology Rsrch Alliance

Los Angeles, California, United States

Site Status

Stanford University Medical Center

Palo Alto, California, United States

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UCLA Pasadena HC Hemato Onco

Pasadena, California, United States

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UCLA Porter Ranch Hemato and Onco

Porter Ranch, California, United States

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Cancer Care Associates Medical Grp

Redondo Beach, California, United States

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Sharp Memorial Hospital

San Diego, California, United States

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UCSF

San Francisco, California, United States

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Central Coast Medical Oncology Corporation

Santa Maria, California, United States

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UCLA Santa Monica Hematology Oncology

Santa Monica, California, United States

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Lundquist Inst BioMed at Harbor

Torrance, California, United States

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UCLA Valencia

Valencia, California, United States

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Valley Breast Care

Van Nuys, California, United States

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UCLA Cancer Center Westlake Village

Westlake Village, California, United States

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University Of Colorado Hospital

Aurora, Colorado, United States

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Rocky Mountain Cancer Centers

Denver, Colorado, United States

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Hospital of Central Connecticut

New Britain, Connecticut, United States

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Yale University School Of Medicine

New Haven, Connecticut, United States

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Norwalk Hospital

Norwalk, Connecticut, United States

Site Status

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Site Status

Holy Cross Hospital-Ft. Lauderdale

Fort Lauderdale, Florida, United States

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Florida Cancer Specialists

Fort Myers, Florida, United States

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Memorial Cancer Institute

Hollywood, Florida, United States

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Baptist MD Anderson Cancer Center

Jacksonville, Florida, United States

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University of Miami

Miami, Florida, United States

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Orlando Health Clinical Trials

Orlando, Florida, United States

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Florida Cancer Specialists-North

St. Petersburg, Florida, United States

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Florida Cancer Specialists Pan

Tallahassee, Florida, United States

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Florida Cancer Specialists

West Palm Beach, Florida, United States

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Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

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Southeastern Regional Medical Center

Newnan, Georgia, United States

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Cancer Treatment Centers of America

Zion, Illinois, United States

Site Status

Cancer Care Center

New Albany, Indiana, United States

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University of Kansas Cancer Center

Westwood, Kansas, United States

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Cancer Center of Kansas

Wichita, Kansas, United States

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Norton Cancer Institute

Louisville, Kentucky, United States

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Mercy Medical Center

Baltimore, Maryland, United States

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Massachusetts General Hospital

Boston, Massachusetts, United States

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University of Michigan Cancer Center

Ann Arbor, Michigan, United States

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Fairview Health Services

Maple Grove, Minnesota, United States

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Metro Minnesota CCOP

Saint Louis Park, Minnesota, United States

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Park Nicollet Institute

Saint Louis Park, Minnesota, United States

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Saint Lukes Hospital of Kansas City

Kansas City, Missouri, United States

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HCA Midwest Division

Kansas City, Missouri, United States

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David C Pratt Cancer Center

St Louis, Missouri, United States

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St Vincent Frontier Cancer Center

Billings, Montana, United States

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Saint Francis Medical Center

Grand Island, Nebraska, United States

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Comprehensive Cancer Cntr Of Nevada

Henderson, Nevada, United States

Site Status

Saint Barnabas Medical Center

Livingston, New Jersey, United States

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Perlmutter Cancer Centre

New York, New York, United States

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Randolph Medical Associates

Asheboro, North Carolina, United States

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Cone Health Cancer Center

Greensboro, North Carolina, United States

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Kaiser Permanente NW Region

Clackamas, Oregon, United States

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Penn State Hershey Cancer Institute

Hershey, Pennsylvania, United States

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Cancer Treatment Centers of America Eastern Regional Medical Center

Philadelphia, Pennsylvania, United States

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The West Clinic

Germantown, Tennessee, United States

Site Status

Sarah Cannon Research Institute

Nashville, Tennessee, United States

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Baylor Charles A Sammons Cancer Cnt

Dallas, Texas, United States

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Ctr For Cancer And Blood Disorders

Fort Worth, Texas, United States

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MD Anderson Cancer Center University of Texas

Houston, Texas, United States

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Utah Cancer Specialists

Salt Lake City, Utah, United States

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Virginia Cancer Specialists

Fairfax, Virginia, United States

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Virginia Cancer Institute

Richmond, Virginia, United States

Site Status

Fred Hutchinson Cancer Center

Seattle, Washington, United States

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University of Wisconsin Paul P Carbone Comp Cancer Center

Madison, Wisconsin, United States

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Novartis Investigative Site

San Salvador de Jujuy, Jujuy Province, Argentina

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Novartis Investigative Site

Rosario, Santa Fe Province, Argentina

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Novartis Investigative Site

Rosario, Sante Fe, Argentina

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Novartis Investigative Site

San Miguel Tucuman, Tucumán Province, Argentina

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Novartis Investigative Site

Rio Negro, Viedma, Argentina

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Novartis Investigative Site

CABA, , Argentina

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Novartis Investigative Site

Córdoba, , Argentina

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Novartis Investigative Site

La Rioja, , Argentina

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Novartis Investigative Site

Campbelltown, New South Wales, Australia

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Novartis Investigative Site

Coffs Harbour, New South Wales, Australia

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Novartis Investigative Site

Darlinghurst, New South Wales, Australia

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Novartis Investigative Site

Kingswood, New South Wales, Australia

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Novartis Investigative Site

Kogarah, New South Wales, Australia

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Novartis Investigative Site

North Ryde, New South Wales, Australia

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Novartis Investigative Site

St Leonards, New South Wales, Australia

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Novartis Investigative Site

Wahroonga, New South Wales, Australia

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Novartis Investigative Site

Westmead, New South Wales, Australia

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Novartis Investigative Site

Auchenflower, Queensland, Australia

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Novartis Investigative Site

Birtinya, Queensland, Australia

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Novartis Investigative Site

Wooloongabba, Queensland, Australia

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Novartis Investigative Site

Bedford Park, South Australia, Australia

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Novartis Investigative Site

Bendigo, Victoria, Australia

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Novartis Investigative Site

East Melbourne, Victoria, Australia

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Novartis Investigative Site

Epping, Victoria, Australia

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Novartis Investigative Site

Fitzroy, Victoria, Australia

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Novartis Investigative Site

Franston, Victoria, Australia

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Novartis Investigative Site

Heidelberg, Victoria, Australia

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Novartis Investigative Site

Melbourne, Victoria, Australia

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Novartis Investigative Site

Shepparton, Victoria, Australia

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Novartis Investigative Site

Murdoch, Western Australia, Australia

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Novartis Investigative Site

Nedlands, Western Australia, Australia

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Novartis Investigative Site

Liverpool, , Australia

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Novartis Investigative Site

Innsbruck, Tyrol, Austria

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Novartis Investigative Site

Graz, , Austria

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Novartis Investigative Site

Linz, , Austria

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Novartis Investigative Site

Salzburg, , Austria

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Novartis Investigative Site

Vienna, , Austria

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Novartis Investigative Site

Brussels, , Belgium

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Novartis Investigative Site

Brussels, , Belgium

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Novartis Investigative Site

Charleroi, , Belgium

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Novartis Investigative Site

Edegem, , Belgium

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Novartis Investigative Site

Hasselt, , Belgium

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Novartis Investigative Site

Jette, , Belgium

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Novartis Investigative Site

Leuven, , Belgium

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Novartis Investigative Site

Libramont, , Belgium

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Novartis Investigative Site

Liège, , Belgium

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Novartis Investigative Site

Namur, , Belgium

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Novartis Investigative Site

Wilrijk, , Belgium

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Novartis Investigative Site

Yvoir, , Belgium

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Novartis Investigative Site

Londrina, Paraná, Brazil

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