CDK 4/6 Inhibitor, Ribociclib, With Adjuvant Endocrine Therapy for ER-positive Breast Cancer

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT03285412
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

  • Ribociclib — DRUG
    Ribociclib is a drug designed to block certain proteins called cyclin-dependent protein kinases 4 and 6 (CDK4/6). These proteins are needed for cells to divide and may also control the ability of certain cancers to grow.
  • Endocrine therapy — OTHER
    Hormone therapy

Study Details

This research study is studying a drug as a possible treatment for ER-positive Breast Cancer The drug involved in this study is: -Ribociclib

Key Dates

Start date
Dec 12, 2017
Status verified
Dec 2025
Primary completion
Apr 30, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ribociclib + Endocrine Rx
    Ribociclib will be administered. Endocrine therapy will be administered.
  • Active Comparator: Endocrine Rx
    Endocrine therapy will be administered.

Primary Outcome Measure

ctDNA clearance [ Time Frame: 12 Months ]

Locations (3)

FacilityCityStateZIPSite coordinators
Beth Israel Deaconess Medical CenterBostonMassachusetts02215-
Massachusetts General HospitalBostonMassachusetts02214-
Mass General/North Shore Cancer CenterDanversMassachusetts01923-

Find similar trials in Boston, MA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Beth Israel Deaconess Medical Center· Boston, MAMassachusetts General Hospital· Boston, MAMass General/North Shore Cancer Center· Danvers, MA

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