Study of Ribociclib With Everolimus + Exemestane in HR+ HER2- Locally Advanced/Metastatic Breast Cancer Post Progression on CDK 4/6 Inhibitor.

Part of paid clinical trials in Chandler, Arizona.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT02732119
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ribociclib — DRUG
    supplied in 50 mg, 200 mg capsules/tablets taken orally and dosed daily for 28 day cycle
  • Everolimus — DRUG
    supplied in 2.5 mg tablets taken orally, daily for 28 day cycle
  • Exemestane — DRUG
    supplied in 25 mg tablets taken orally, daily for 28 day cycle

Study Details

The purpose of this study is determine if the triplet combination of ribociclib, everolimus and exemastane is safe and effective in the treatment of locally advanced/metastatic breast cancer following treatment with a CDK 4/6 inhibitor

Key Dates

Start date
Jun 14, 2016
Status verified
Apr 2021
Primary completion
Feb 25, 2020
Completion
Feb 25, 2020

Study Design

Enrollment
104 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A
    Ribociclib (250 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally for 28 days. If no DLTs occurred, progressed to Cohort B
  • Experimental: Cohort B
    Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
  • Experimental: Cohort C
    Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally
  • Experimental: Group 1
    Ribociclib (300 mg daily), everolimus (2.5 mg daily) and exemestane (25 mg daily) taken orally
  • Experimental: Group 2
    Ribociclib (200 mg daily), everolimus (5 mg daily) and exemestane (25 mg daily) taken orally

Primary Outcome Measure

Participants With Dose Limiting Toxicities by Preferred Term in Cycle 1 (28 Days) - in Phase I [ Time Frame: Baseline up to 28 days ]

Locations (25)

FacilityCityStateZIPSite coordinators
Ironwood Cancer and Research Centers Ironwood CancerChandlerArizona85224-
Highlands Oncology GroupFayettevilleArkansas72703-
UCLA Department of Medicine UCLA Hematology/OncologyLos AngelesCalifornia90095-
University of California San Francisco Comprehensive Cancer CenterSan FranciscoCalifornia94115-
Central Coast Medical Oncology Corporation Onc DeptSanta MariaCalifornia93454-
Yale University School of Medicine Smilow Cancer HospitalNew HavenConnecticut06511-
Florida Cancer Research Institute Dept of OncologyDavieFlorida33328-
Florida Cancer Specialists FL Cancer SpecialistsFort MyersFlorida33901-
UF Health Cancer Center at Orlando Health UF Health (4)OrlandoFlorida32806-
Florida Cancer Specialists-NorthSt. PetersburgFlorida33705-
Atlanta Cancer CenterAtlantaGeorgia--
University of Kansas Cancer Center Univ of KS CC Medical PavilionWestwoodKansas66205-
Massachusetts General Hospital Mass Gen Hos Cancer CenterBostonMassachusetts02114-
Henry Ford Health SystemDetroitMichigan48202-
Research Medical Center HCA Midwest DivisionKansas CityMissouri64132-
St. Luke's Cancer Institute RegulatoryKansas CityMissouri64111-
Washington University School of Medicine Washington U School of MedicinSt LouisMissouri63110-
Saint Barnabas Medical CenterLivingstonNew Jersey07039-
Penn State Hershey Cancer InstituteHersheyPennsylvania17033-
University of Pennsylvania Medical Center Abramson Cancer Ctr of the UniPhiladelphiaPennsylvania19104-
Sarah Cannon Research Institute Sarah Cannon Research InstiNashvilleTennessee37203-
MD Anderson Cancer Center/University of Texas MDACCHoustonTexas77030-
Oncology Consultants Oncology ConsultantsHoustonTexas77024-
Huntsman Cancer Institute Huntsman Cancer InstiSalt Lake CityUtah84112-
Northwest Medical Specialties Dept of OncTacomaWashington98405-

Find similar trials in Chandler, AZ

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Ironwood Cancer and Research Centers Ironwood Cancer· Chandler, AZHighlands Oncology Group· Fayetteville, ARUCLA Department of Medicine UCLA Hematology/Oncology· Los Angeles, CAUniversity of California San Francisco Comprehensive Cancer Center· San Francisco, CACentral Coast Medical Oncology Corporation Onc Dept· Santa Maria, CAYale University School of Medicine Smilow Cancer Hospital· New Haven, CT

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