Abemaciclib in Combination With Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT05095207
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 90 Years
Healthy Volunteers
Accepted

Interventions

  • Abemaciclib — DRUG
    100 mg orally twice daily, day 1 to 28. If no toxicity in cycle 1 for the first 3 patients, increase dose to 150mg orally twice daily day 1-28 and enroll 3 patients. If excessive toxicity experienced at 100mg orally twice daily dose, decrease dose to 50mg orally twice daily day 1-28.
  • Bicalutamide — DRUG
    150 mg orally daily, day 1 to 28.

Study Details

This is an open label multicenter, Phase IB/II Study of Abemaciclib in Combination with Bicalutamide for Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer

Key Dates

Start date
Sep 20, 2021
Status verified
Apr 2026
Primary completion
Jun 30, 2027
Completion
Jun 30, 2028

Study Design

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

Arms

  • Experimental: Participants with Androgen Receptor-positive, HER2-negative Metastatic Breast Cancer
    Abemaciclib in Combination with Bicalutamide

Primary Outcome Measure

The Dose-Limiting Toxicity (DLT) and Recommended Phase II Dose (RP2D) [ Time Frame: 12 weeks ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Dubin breast CenterNew YorkNew York10029
Atul G Joshi, MS
[email protected]
212-824-7320
Amy Tiersten (PRINCIPAL_INVESTIGATOR)
Mount Sinai - WestNew YorkNew York10019-
Mount Sinai Beth IsraelNew YorkNew York10003-

Find similar trials in New York, NY

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Dubin breast Center· New York, NYMount Sinai - West· New York, NYMount Sinai Beth Israel· New York, NY

Related Studies