Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT05524584

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

Led by University of California, Irvine · Updated on 2026-03-11

20

Participants Needed

1

Research Sites

487 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of hormone receptor-positive breast cancer with at least 1% tumor cell nuclei positive by immunohistochemistry
  • Newly diagnosed metastatic regional breast cancer or local-regional advanced or recurrent cancer not curable by surgery or radiation
  • Relapse more than 12 months after completion of prior (neo)adjuvant endocrine or chemotherapy, or no prior systemic treatment for early breast cancer
  • Age 18 years or older
  • ECOG performance status of 0 to 2
  • Post-menopausal status defined by prior bilateral oophorectomy, age 60 or older, or age under 60 and amenorrheic for at least 12 months with FSH and estradiol in postmenopausal range; ovarian suppression if pre-menopausal
  • At least one measurable disease per RECIST 1.1
  • Adequate organ and marrow function including hemoglobin >8 g/dL, neutrophils ≥1,500/mcL, platelets ≥100,000/mcL, bilirubin ≤1.5 times upper limit of normal, AST/ALT ≤2.5 times upper limit, creatinine ≤1.5 times upper limit
  • Able to swallow oral medications
  • Recovery from acute effects of prior chemotherapy or radiotherapy (Grade ≤1) except residual alopecia or Grade 2 peripheral neuropathy
  • Persons of childbearing potential and men must agree to use ovarian or testicular suppression during study and for 90 days after
  • Able to sign informed consent, reliable, willing to follow study procedures and be available for study duration
  • Eligible regardless of race, ethnicity, language, hearing, or literacy status
Not Eligible

You will not qualify if you...

  • Localized breast cancer curable with surgery or radiation, with or without chemotherapy
  • Current diagnosis of inflammatory breast cancer
  • Chemotherapy or radiotherapy within 12 months prior to study entry (except palliative radiotherapy)
  • Prior treatment with fulvestrant (except within 8 weeks prior to study start for current diagnosis)
  • Participation in other investigational drug trials or incompatible medical research
  • Serious pre-existing medical conditions such as major gastrointestinal surgery, Crohn's disease, ulcerative colitis, interstitial lung disease, severe dyspnea at rest, grade 2 or higher baseline diarrhea, or psychiatric/social issues limiting compliance
  • Personal history of syncope with cardiovascular cause, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest
  • History of other cancers unless in remission without therapy for at least 3 years or post-stem cell transplant over 5 years ago
  • Active bacterial, fungal, or viral infections (e.g., HIV, hepatitis)
  • Recent biologic or monoclonal antibody therapy without adequate washout
  • History of allergic reactions to CDK4/6 inhibitors or similar compounds
  • Pregnant or nursing women due to potential risks to fetus or infant

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Chao Family Comprehensive Cancer Center, University of California, Irvine

Orange, California, United States, 92868

Actively Recruiting

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Research Team

C

Chao Family Comprehensive Cancer Center University of California, Irvine

CONTACT

U

University of California Irvine Medical

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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