Letrozole Plus Ribociclib or Placebo as Neo-adjuvant Therapy in ER-positive, HER2-negative Early Breast Cancer

Part of paid clinical trials in Little Rock, Arkansas.

Sponsor
Qamar Khan
Study ID
NCT02712723
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Letrozole — DRUG
    Nonsteroidal aromatase inhibitor
  • Ribociclib — DRUG
    Oral cyclin-dependent kinase (CDK) inhibitor
  • Placebo — DRUG
    Placebo for ribociclib

Study Details

The purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with Pre-operative Endocrine Prognostic Index (PEPI) score of 0 at surgery compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.

Key Dates

Start date
Feb 29, 2016
Status verified
Feb 2026
Primary completion
Aug 27, 2018
Completion
Dec 31, 2026

Study Design

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

Arms

  • Active Comparator: Placebo + Letrozole
    Placebo randomized to 3 capsules/day 3 weeks on/1week off or 2 capsules/day continuous dosing + Letrozole 2.5 mg PO daily
  • Experimental: Ribociclib 600 mg + Letrozole
    Ribociclib 600 mg PO daily 21 days on/7 days off + Letrozole 2.5 mg PO daily
  • Experimental: Ribociclib 400 mg + Letrozole
    Ribociclib 400 mg continuous daily dosing + Letrozole 2.5 mg PO daily

Primary Outcome Measure

Rate of PEPI Score 0 at Surgery Between Ribociclib Containing Arms (Combined) vs. Letrozole Alone Arm. [ Time Frame: 24 weeks ]

Locations (13)

FacilityCityStateZIPSite coordinators
University of Arkansas for Medical SciencesLittle RockArkansas72205-
City of Hope National Medical CenterDuarteCalifornia91010-
Cancer Research CollaborationSanta AnaCalifornia92705-
University of Miami Sylvester Comprehensive Cancer CenterDeerfield BeachFlorida33442-
University of Kansas Cancer Center - WestKansas CityKansas66112-
University of Kansas Cancer Center - Overland ParkOverland ParkKansas66210-
University of Kansas Cancer Center - WestwoodWestwoodKansas66205-
Massachusetts General HospitalBostonMassachusetts02114-
University of Kansas Cancer Center - NorthKansas CityMissouri64154-
University of Kansas Cancer Center - SouthKansas CityMissouri64131-
University of Kansas Cancer Center - Lee's SummitLee's SummitMissouri64064-
Columbia University Medical CenterNew YorkNew York10032-
University of Wisconsin Carbone Cancer CenterMadisonWisconsin53705-

Find similar trials in Little Rock, AR

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Arkansas for Medical Sciences· Little Rock, ARCity of Hope National Medical Center· Duarte, CACancer Research Collaboration· Santa Ana, CAUniversity of Miami Sylvester Comprehensive Cancer Center· Deerfield Beach, FLUniversity of Kansas Cancer Center - West· Kansas City, KSUniversity of Kansas Cancer Center - Overland Park· Overland Park, KS

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