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Cyclin-Dependent Kinase Inhibitor

Combination Therapy for Advanced Breast Cancer

Phase 2

Recruiting

Led By Rita Mehta, MD

Research Sponsored by University of California, Irvine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Post-menopausal status as defined by specific criteria

Patients must have a diagnosis of HR+ breast cancer with at least one hormone receptor (ER, PgR) expression by immunohistochemistry (IHC)

Must not have

Patients with HER2 positive and triple negative breast cancer

Inflammatory breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new combination therapy for breast cancer that has progressed following treatment or for newly diagnosed advanced or metastatic hormone receptor positive breast cancer.

Who is the study for?

This trial is for post-menopausal women with HR+HER2- advanced or metastatic breast cancer, who have relapsed more than a year after prior treatments. Participants must be over 18, in good health with proper organ function, and not currently pregnant. They should agree to contraception if of child-bearing potential.

What is being tested?

The study tests a combination therapy using Anastrazole, Fulvestrant & Abemaciclib on patients newly diagnosed with advanced breast cancer or those whose cancer returned after treatment-free interval of over 12 months.

What are the potential side effects?

Possible side effects include fatigue, nausea, diarrhea, low blood cell counts leading to increased infection risk, liver problems, blood clots and potential harm to an unborn baby if the patient becomes pregnant during treatment.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am post-menopausal.

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My breast cancer is hormone receptor positive.

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I am 18 years old or older.

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I am able to get out of my bed or chair and move around.

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My breast cancer is newly diagnosed as stage IV or is advanced and cannot be cured.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My breast cancer is HER2 positive or triple negative.

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I have been diagnosed with inflammatory breast cancer.

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I have had chemotherapy or radiotherapy within the last year.

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I have been treated with Fulvestrant before.

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My breast cancer can be treated with surgery or radiation.

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I do not have any active infections.

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I am allergic to certain cancer medications similar to CDK4/6 inhibitors.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Objective Response Rate (ORR)

Secondary study objectives

Clinical Benefit Rate

Number of grade 3-5 adverse events

Number of patients who achieved composite outcome

+2 more

Side effects data

From 2018 Phase 4 trial • 79 Patients • NCT02137538

10%

Fracture

Acne

Scoliosis

Hair loss

Sacroiliitis

Neuro event

100%

80%

60%

40%

20%

Study treatment Arm

Anastrozole

Letrozole

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Fulvestrant + Anastrozole + AbemaciclibExperimental Treatment3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fulvestrant

2011

Completed Phase 3

~3510

Anastrozole

2016

Completed Phase 4

~5550