Breast Cancer Clinical Trial

Study of 2 Ribociclib Doses in Combination With Aromatase Inhibitors in Women With HR+, HER2- Advanced Breast Cancer

Summary

QT interval prolongation and neutropenia are considered to be important identified risks for ribociclib. The approved dosing regimen of ribociclib is 600 mg daily (QD) on a 3 weeks on/1 week off schedule.

The purpose of the study is to explore whether a reduced dosing regimen of 400 mg ribociclib orally QD 3 weeks on/1 week off may decrease the risk of QTc prolongation without compromising the efficacy of ribociclib in combination with an NSAI in pre- and postmenopausal women with HR-positive, HER2-negative aBC who have received no prior therapy for advanced disease. The risks of other AEs of special interest, such as neutropenia and hepatobiliary toxicity will be evaluated in this study as well.

Approximately 350 patients will be randomly assigned to one of the below treatment arms in a 1:1 ratio: Experimental arm (Arm 1) - Ribociclib 400 mg QD 3 weeks on/1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Control arm (Arm 2) - Ribociclib 600 mg QD 3 weeks on/1 week off + NSAI (+ goserelin in premenopausal women): 175 patients Randomization will be stratified by the presence of lung and/or liver metastases (yes versus no).

View Eligibility Criteria

Eligibility Criteria

Key Inclusion criteria:

Patient has advanced (loco-regionally recurrent or metastatic) breast cancer not amenable to curative therapy.

Patient has a histologically and/or cytologically confirmed diagnosis of ER-positive and/or PgR-positive breast cancer based on the most recently analyzed tissue sample, and all tested by local laboratory.

Patient has 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 is required by local laboratory testing and based on the most recently analyzed tissue sample.

Patient must have measurable disease, i.e., at least one measurable lesion according to RECIST version 1.1. (a lesion in a previously irradiated site may only be counted as a target lesion if there is clear evidence of progression since the irradiation).

Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

Standard 12-lead ECG values defined as the mean of the triplicate ECGs and assessed by the central laboratory:

QTcF interval at screening < 450 ms (QT interval using Fridericia's correction)
Mean resting heart rate 50 to 90 bpm (determined from the ECG)

Women of childbearing potential (CBP), defined as all women physiologically capable of becoming pregnant, must have confirmed negative serum pregnancy test (for β-hCG) within 14 days prior to randomization.

Women of CBP must be willing to use highly effective methods of contraception.

Key Exclusion Criteria:

Patient with symptomatic visceral disease or any disease burden that makes the patient ineligible for endocrine therapy per the investigator's judgment.

Patient who received any prior systemic anti-cancer therapy(including endocrine therapy, chemotherapy, prior CDK4/6 inhibitors) for aBC. Patients who received neo-/adjuvant therapy for breast cancer are eligible.

Patient is concurrently using other anti-cancer therapy.

Patient has had major surgery within 14 days prior to starting study drug or has not recovered from major toxicities.

Patient has received extended-field radiotherapy ≤ 4 weeks or limited field radiotherapy ≤ 2 weeks prior to randomization, and has not recovered to grade 1 or better from related side effects of such therapy (with the exception of alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion). Patients in whom ≥ 25% of the bone marrow has been previously irradiated are also excluded.

Patient has a concurrent malignancy or malignancy within 3 years of the randomization date, with the exception of adequately treated basal or squamous cell skin carcinoma, or curatively resected cervical carcinoma in situ.

Patients with central nervous system (CNS) involvement unless they meet specific stability criteria.

Patient has clinically significant, uncontrolled heart disease and/or cardiac repolarization abnormality.

Patient is currently receiving or has received systemic corticosteroids ≤ 2 weeks prior to starting study drug, and has not fully recovered from side effects of such treatment.

Other protocol-defined Inclusion/Exclusion may apply.

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

376

Study ID:

NCT03822468

Recruitment Status:

Active, not recruiting

Sponsor:

Novartis Pharmaceuticals

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There are 88 Locations for this study

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Southern Cancer Center PC
Mobile Alabama, 36608, United States
Marin Cancer Care
Greenbrae California, 94904, United States
Rocky Mountain Cancer Centers Rocky Mountain Cancer Ctr (50)
Longmont Colorado, 80501, United States
Florida Retina Institute
Orlando Florida, 32804, United States
Emory University School of Medicine/Winship Cancer Institute
Atlanta Georgia, 30322, United States
Weinberg Cancer Institute at Franklin Square Hospital
Baltimore Maryland, 21237, United States
Nebraska Hematology-Oncology, P.C.
Lincoln Nebraska, 68506, United States
Nebraska Cancer Specialists Oncology Hematology West
Omaha Nebraska, 68154, United States
Comprehensive Cancer Centers of Nevada CCC of Nevada Henderson (4)
Henderson Nevada, 89052, United States
New York Oncology Hematology SC
Albany New York, 12208, United States
Montefiore Medical Center
Bronx New York, 10467, United States
Mount Sinai School of Medicine CFTY720D2306
New York New York, 10029, United States
Millennium Research Clin Develop
Houston Texas, 77090, United States
Texas Oncology
McAllen Texas, 78503, United States
Northwest Medical Specialties Dept.ofNW Med. Specialties
Tacoma Washington, 98405, United States
Novartis Investigative Site
San Juan , J5402, Argentina
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Innsbruck , A-602, Austria
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Linz , 4010, Austria
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Salzburg , 5020, Austria
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Vienna , 1090, Austria
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Edegem Antwerpen, 2650, Belgium
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Namur , 5000, Belgium
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Goiania GO, 74605, Brazil
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Natal RN, 59075, Brazil
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Florianopolis Santa Catarina, 88034, Brazil
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Sao Paulo SP, 01317, Brazil
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Sao Paulo SP, 04014, Brazil
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Sao Jose do Rio Preto , 15090, Brazil
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Plovdiv , 4004, Bulgaria
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Sofia , 1303, Bulgaria
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Sofia , 1756, Bulgaria
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Cambridge Ontario, N1R 3, Canada
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Valledupar Cesar, 56023, Colombia
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Ibague Tolima, 73000, Colombia
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Bogota , 11022, Colombia
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Bogota , , Colombia
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Monteria , 23000, Colombia
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San Jose , , Costa Rica
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Brno Czech Republic, 656 5, Czechia
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Praha 5 , 150 0, Czechia
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Helsinki , 00029, Finland
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Tampere , FIN-3, Finland
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Besancon Cedex , 25030, France
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Caen Cedex , 14021, France
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Clermont Ferrand , 63011, France
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Lyon Cedex 08 , 69373, France
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Marseille , 13273, France
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Montpellier Cedex 5 , 34298, France
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Saint Herblain cedex , 44805, France
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Strasbourg , F 670, France
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Valenciennes , 59300, France
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Langen Hessen, 63225, Germany
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Augsburg , 86150, Germany
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Berlin , 13581, Germany
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Bonn , 53111, Germany
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Dresden , 01127, Germany
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Dresden , 01307, Germany
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Essen , 45136, Germany
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Tübingen , 72076, Germany
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Weiden , 92637, Germany
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Budapest , H 112, Hungary
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Debrecen , 4032, Hungary
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Szolnok , H-500, Hungary
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Raipur Chhattisgarh, 49200, India
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Nagpur Maharashtra, 44110, India
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Bhubaneshwar Orissa, 75100, India
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Delhii , 110 0, India
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Mumbai , 400 0, India
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Amman , 11941, Jordan
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Kaunas LTU, LT 50, Lithuania
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Vilnius , LT-08, Lithuania
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Trujillo La Libertad, , Peru
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San Borja Lima, 41, Peru
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San Isidro Lima, 27, Peru
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San Miguel Lima, 32, Peru
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Lisbon , 1400 , Portugal
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Loures , 26745, Portugal
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Porto , 4200-, Portugal
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Arkhangelsk , 16304, Russian Federation
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Moscow , 11112, Russian Federation
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Moscow , 11547, Russian Federation
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St Petersburg , 19775, Russian Federation
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St-Petersburg , 18964, Russian Federation
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Cape Town , 7500, South Africa
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Johannesburg , 2196, South Africa
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Parktown , 2193, South Africa
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Stockholm , 112 1, Sweden
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Stockholm , SE-11, Sweden
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Uppsala , 751 8, Sweden
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Bangkok , 10700, Thailand
Novartis Investigative Site
Chiang Mai , 50200, Thailand

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

376

Study ID:

NCT03822468

Recruitment Status:

Active, not recruiting

Sponsor:


Novartis Pharmaceuticals

How clear is this clinincal trial information?

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