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Aromatase Inhibitor

Endocrine Therapy for Breast Cancer

Phase 2
Waitlist Available
Led By Priscilla McAuliffe, MD
Research Sponsored by Priscilla McAuliffe
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status of 0, 1 or 2
Patients must be female
Must not have
Prior or concurrent use of hormonal therapy, chemotherapy, radiation therapy, or novel therapy to treat the current breast cancer
Active hepatitis viral infections or a known history of liver disease, especially moderate to severe hepatic impairment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline (prior to treatment) to day 21-24
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying whether fulvestrant is more effective than anastrozole or tamoxifen in reducing Ki67 in ILC and whether that Ki67 reduction will correlate with alterations in expression of ER and ER-regulated genes.

Who is the study for?
This trial is for postmenopausal women with a specific type of breast cancer called invasive lobular carcinoma, which is hormone receptor-positive and HER2-negative. They should be in clinical stages I-III, have a tumor at least 1 cm large, and an ECOG performance status of 0 to 2 indicating they are fully active or can do light work.
What is being tested?
The study tests the effectiveness of three drugs—fulvestrant, anastrozole, and tamoxifen—in reducing Ki67 levels in breast cancer tissue. This reduction may indicate how well these treatments could work for this subtype of breast cancer. Women will receive one of these drugs before their surgery or further treatment.
What are the potential side effects?
Common side effects from these medications include hot flashes, joint pain, nausea, fatigue, mood changes and risk of blood clots. Fulvestrant might cause injection site reactions while anastrozole may lead to bone thinning over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself and perform daily activities.
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I am female.
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I have gone through menopause completely.
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My breast cancer is invasive, not spread widely, hormone-sensitive, HER2-negative, and at least 1cm big.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have used hormone, chemo, radiation, or new treatments for my current breast cancer.
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I do not have active hepatitis or severe liver disease.
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My cancer is HER-2 positive.
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I have a history of bleeding easily or very low platelet counts.
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I am allergic to tamoxifen, anastrozole, fulvestrant, or their ingredients.
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I have a history of blood clots or uterine cancer that makes tamoxifen unsafe for me.
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I do not have any uncontrolled illnesses that could affect my participation.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (prior to treatment) to day 21-24
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline (prior to treatment) to day 21-24 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change in Ki67 proliferative index
Secondary study objectives
Change in Ki67
Estrogen receptor (ER) protein expression
Estrogen receptor (ER) related gene expression
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups
Active Control
Group I: fulvestrantActive Control1 Intervention
500 mg, administered as two 250 mg IM injections, given on days 1 and 14
Group II: tamoxifenActive Control1 Intervention
Tamoxifen is administered orally, at a dose of 20 mg,daily, for 21 days
Group III: AnastrozoleActive Control1 Intervention
1mg given orally daily for 21 days

Find a Location

Who is running the clinical trial?

Priscilla McAuliffeLead Sponsor
Priscilla McAuliffe, MD5.05 ReviewsPrincipal Investigator - UPMC Magee Womens Hopspital
University of Pittsburgh
5Patient Review
Dr. McAuliffe was verykind and helpful after my breast cancer diagnosis. She answered all of my questions and made me feel comfortable.
~20 spots leftby Dec 2025
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