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

Part of paid clinical trials in Mobile, Alabama.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT03822468
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    Ribociclib (at a dosage of 400 mg or 600 mg) QD orally taken on days 1 to 21 of a 28-day cycle, followed by 7 days off ribociclib (days 22 to 28). Ribociclib was supplied as 200 mg tablets as individual patient supply packaged bottles.
  • Anastrozole — DRUG
    Anastrozole 1 mg tablets for oral use QD continuously
  • Letrozole — DRUG
    Letrozole 2.5 mg tablets for oral use QD continuously
  • Goserelin — DRUG
    Goserelin 3.6 mg subcutaneously once every 4 weeks (pre-menopausal women only)

Study Details

The purpose of the study was to evaluate the safety and efficacy of a reduced ribociclib starting dose of 400 mg in combination with a non-steroidal aromatase inhibitor (NSAI) (letrozole or anastrozole) for the treatment of pre- and postmenopausal women with hormone receptor-positive (HR-positive), HER2-negative advanced breast cancer (aBC) who have received no prior therapy for advanced disease. Premenopausal women were required to receive goserelin in both treatment arms.

Key Dates

Start date
Jun 11, 2019
Status verified
Oct 2025
Primary completion
Jun 11, 2021
Completion
Aug 30, 2024

Study Design

Enrollment
376 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ribociclib 400 mg
    Ribociclib 400 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+goserelin in premenopausal women)
  • Active Comparator: Ribociclib 600 mg
    Ribociclib 600 mg QD 3 weeks on/1 week off + letrozole or anastrozole (+ goserelin in premenopausal women)

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: Up to 23.8 months ]

Locations (14)

FacilityCityStateZIPSite coordinators
Southern Cancer Center PCMobileAlabama36608-
Marin Cancer CareGreenbraeCalifornia94904-
Rocky Mountain Cancer CentersLongmontColorado80501-
Florida Retina InstituteOrlandoFlorida32804-
Weinberg Cancer Institute at FSHBaltimoreMaryland21237-3998-
Nebraska Hematology Oncology P CLincolnNebraska68506-
Nebraska Cancer SpecialistsOmahaNebraska68154-
Comprehensive Cancer Cntr Of NevadaHendersonNevada89052-
New York Oncology HematologyAlbanyNew York12208-
Mount Sinai School Of MedicineNew YorkNew York10029-
Montefiore Medical CenterThe BronxNew York10467-
Millennium Research Clin DevelopHoustonTexas77090-
Texas OncologyMcAllenTexas78503-
Northwest Medical SpecialtiesTacomaWashington98405-

Find similar trials in Mobile, AL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Southern Cancer Center PC· Mobile, ALMarin Cancer Care· Greenbrae, CARocky Mountain Cancer Centers· Longmont, COFlorida Retina Institute· Orlando, FLWeinberg Cancer Institute at FSH· Baltimore, MDNebraska Hematology Oncology P C· Lincoln, NE

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