Anastrazole, Fulvestrant & Abemaciclib for HR+HER2- Metastatic Breast Cancer

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT05524584
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

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

Interventions

  • Fulvestrant — DRUG
    Given intramuscularly
  • Anastrozole — DRUG
    Given orally
  • Abemaciclib — DRUG
    Given orally

Study Details

This is a phase 2, open-label, singled-arm clinical trial determining efficacy of combination therapy with anastrozole, fulvestrant and abemaciclib in subjects with breast cancer. These are subjects who are newly diagnosed advanced or metastatic hormone receptor positive breast cancer or subjects who have progressed following treatment free interval of more than 12 months following adjuvant or neoadjuvant treatment.

Key Dates

Start date
Aug 31, 2022
Status verified
Nov 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2031

Study Design

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

Arms

  • Experimental: Fulvestrant + Anastrozole + Abemaciclib
    Fulvestrant, intramuscular, Initial: 500 mg on days 1 and 15; Maintenance: 500 mg once monthly. Anastrozole, oral, 1mg tablet daily Abemaciclib 150 mg twice daily

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Assessed at 3 months after study treatment ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-7883
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center, University of California, IrvineOrangeCalifornia92868
Rita Mehta, MD
[email protected]
877-827-8839

Find similar trials in Orange, CA

By condition
Breast cancer
By specialty
OncologyBreast oncologyWomen's health
By research site
Chao Family Comprehensive Cancer Center, University of California, Irvine· Orange, CA

Related Studies