Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer

Part of paid clinical trials in Fayetteville, Arkansas.

Sponsor
Novartis Pharmaceuticals
Study ID
NCT01857193
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • ribociclib (LEE011) — DRUG
    LEE011 is taken orally once per day for 21 days of each 28 day cycle. LEE011 comes in 50 mg and 200 mg capsules.
  • Exemestane — DRUG
    Exemestane is taken orally once per day. Exemestane comes in 25 mg tablets.
  • Everolimus (RAD001) — DRUG
    Everolimus is taken orally once per day. Everolimus comes in 1 mg, 2.5 mg, 5mg, and 7.5 mg tablets

Study Details

Dose Escalation part of the study: To estimate the MTD(s) and/ or RP2D of LEE011 in combination with everolimus + exemestane, and LEE011 in combination with exemestane, and to characterize the safety and tolerability of the combinations of everolimus + exemestane + LEE011 and LEE011 + exemestane in patients with ER+ HER2- advanced breast cancer Dose Expansion part of the study: To characterize the safety and tolerability of the triplet combination of LEE011 + everolimus + exemestane in patients naïve or refractory to CDK4/6 inhibitor based therapy, and the safety and tolerability of the doublet combination of LEE011 + exemestane in patients refractory to CDK4/6 inhibitor based therapy (except patients treated with prior LEE011 are not allowed in Group 3).

Key Dates

Start date
Sep 6, 2013
Status verified
Apr 2021
Primary completion
Mar 14, 2018
Completion
Apr 16, 2020

Study Design

Enrollment
132 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: L-R-E arm
    Participants who took ribociclib (LEE011), everolimus (RAD001) and exemestane triple combination
  • Experimental: L-E arm
    Participants who ribociclib (LEE011) and exemestane double combination

Primary Outcome Measure

Dose Escalation: Incidence of Dose Limiting Toxicity (DLT) [ Time Frame: At the end of Cycle 1 (each cycle is 28 days) ]

Locations (8)

FacilityCityStateZIPSite coordinators
Highlands Oncology GroupFayettevilleArkansas72703-
Sylvester Comprehensive Cancer Center Main CenterMiamiFlorida33136-
Massachusetts General Hospital Onc DeptBostonMassachusetts02114-
Karmanos Cancer Institute Dept of OncDetroitMichigan48201-
Memorial Sloan Kettering Oncology Dept.New YorkNew York10017-
Oregon Health and Science University SC-5PortlandOregon97239-
University of Texas MD Anderson Cancer Center Onc DeptHoustonTexas77030-
Northwest Medical SpecialtiesTacomaWashington98405-

Find similar trials in Fayetteville, AR

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Highlands Oncology Group· Fayetteville, ARSylvester Comprehensive Cancer Center Main Center· Miami, FLMassachusetts General Hospital Onc Dept· Boston, MAKarmanos Cancer Institute Dept of Onc· Detroit, MIMemorial Sloan Kettering Oncology Dept.· New York, NYOregon Health and Science University SC-5· Portland, OR

Related Studies