RecruitingPhase 2NCT05524584

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

Phase II, Open-Labeled, Single-Armed Combination Treatment With Anastrozole, Fulvestrant and Abemaciclib for Hormone Receptor Positive, HER2(-) Metastatic Breast Cancer


Sponsor

University of California, Irvine

Enrollment

20 participants

Start Date

Aug 31, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a combination of three drugs — anastrozole, fulvestrant, and abemaciclib — for postmenopausal women (or those with suppressed ovarian function) who have hormone receptor-positive, HER2-negative metastatic breast cancer that has recently spread or cannot be cured surgically. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with hormone receptor-positive (ER+ or PgR+), HER2-negative breast cancer that is metastatic (stage IV) or locally advanced and not curable with surgery - Your cancer relapsed more than 12 months after completing hormone therapy or chemotherapy (or you received no prior systemic treatment for early-stage disease) - You are postmenopausal (either naturally, or through ovarian suppression if premenopausal) - Your overall health status is good (ECOG 0–2) **You may NOT be eligible if...** - You have been treated for metastatic or advanced disease previously (with some exceptions) - Your cancer relapsed within 12 months of completing (neo)adjuvant treatment - You are premenopausal without plans for ovarian suppression - Your overall health is too poor for treatment - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGFulvestrant

Given intramuscularly

DRUGAnastrozole

Given orally

DRUGAbemaciclib

Given orally


Locations(1)

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States

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NCT05524584


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