Ribociclib and Bicalutamide in AR+ TNBC

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Kari Wisinski
Study ID
NCT03090165
Phase
PHASE1/PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

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

Interventions

Study Details

This is an open label, multi-institutional, single arm phase II trial of ribociclib in combination with bicalutamide in advanced AR+ triple-negative breast cancer. No randomization or blinding is involved.

Key Dates

Start date
May 7, 2018
Status verified
Dec 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
37 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Arm A - Phase I
    Dose Escalation Cohort 1 will consist of 3-6 patients who will receive bicalutamide 150mg PO daily on days 1-28 of a 28 day cycle and ribociclib 400mg PO daily on days 1-21 of a 28 day cycle. Cohort 2 will consist of 3-6 patients who will receive bicalutamide 150mg PO daily on days 1-28 of a 28 day cycle and ribociclib 400mg PO daily on days 1-28 of a 28 day cycle. Cohort 3 will consist of 3-6 patients who will receive bicalutamide 150mg PO daily on days 1-28 of a 28 day cycle and ribociclib 600mg PO daily on days 1-21 of a 28 day cycle. Experimental: Arm B - Phase II Investigational Treatment The maximum safe dose of ribociclib in combination with bicalutamide will be given to up to 25 patients.

Primary Outcome Measure

Phase I: Maximum Tolerated Dose [ Time Frame: D1 of treatment to end of cohort cycle (assessed at 28 days) ]

Locations (6)

FacilityCityStateZIPSite coordinators
University of Illinois Cancer CenterChicagoIllinois60612-
Michigan State UniversityLansingMichigan48910-
Rutgers Cancer Institute of New JerseyNew BrunswickNew Jersey08903-
University of Rochester Medical CenterRochesterNew York14642-
Penn State Cancer InstituteHersheyPennsylvania17033-
University of WisconsinMadisonWisconsin53792-

Find similar trials in Chicago, IL

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
University of Illinois Cancer Center· Chicago, ILMichigan State University· Lansing, MIRutgers Cancer Institute of New Jersey· New Brunswick, NJUniversity of Rochester Medical Center· Rochester, NYPenn State Cancer Institute· Hershey, PAUniversity of Wisconsin· Madison, WI

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