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Aromatase Inhibitor

fulvestrant 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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline (prior to treatment) to day 21-24

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline (prior to treatment) to day 21-24

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in Ki67 proliferative index

Secondary outcome measures

Change in Ki67

Estrogen receptor (ER) protein expression

Estrogen receptor (ER) related gene expression

+1 more

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

0 / 4Eligibility criteria met

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.

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Have any additional investigations been conducted concerning tamoxifen?

"Presently, there are 223 clinical trials concerning tamoxifen with 61 of them in their final stage. While many locations for these studies exist in Shanghai, a total of 13690 sites across the global are operating research into this medication's efficacy."

Answered by AI

Are there any vacancies for enrolment in this experiment?

"According to clinicaltrials.gov, this particular trial is still open for enrollment. It was first unveiled on the 30th of September 2015 and has been updated most recently on April 7th 2022."

Answered by AI

What is the current enrolment capacity for this experiment?

"To successfully launch this medical trial, 201 suitable individuals need to join. These candidates can be based in Philadelphia's Abramson Cancer Center of the University of Pennsylvania or Pittsburgh's Magee Womens Hospital at UPMC."

Answered by AI

To what maladies does tamoxifen serve as a remedy?

"Tamoxifen has been used to stymie the progression of various diseases, and can be applied to malignant neoplasms, ovarian cancer, as well as high-risk cases."

Answered by AI

Has the Federal Drug Administration approved tamoxifen as a legitimate medication?

"With a score of 2, tamoxifen is considered moderately safe based on the limited evidence currently available from Phase 2 trials."

Answered by AI

What is the present geographic breadth of this experiment?

"There are currently 12 sites enrolling patients in this trial, stretching from Philadelphia to the Bronx and several other cities. To reduce travel commitments, it is suggested that you look into the centre nearest your home if you wish to participate."

Answered by AI

Recent research and studies

Molecular Cancer ResearchJournal

Mediator of DNA Damage Checkpoint 1 (MDC1) Is a Novel Estrogen Receptor Coregulator in Invasive Lobular Carcinoma of the Breast

Sottnik, Joseph L., Evelyn K. Bordeaux, Sanjana Mehrotra, Sarah E. Ferrara, Andrew E. Goodspeed, James C. Costello, and Matthew J. Sikora. 2021. “Mediator of DNA Damage Checkpoint 1 (MDC1) Is a Novel Estrogen Receptor Coregulator in Invasive Lobular Carcinoma of the Breast”. Molecular Cancer Research. American Association for Cancer Research (AACR). doi:10.1158/1541-7786.mcr-21-0025.

clinicaltrials.govStudy

Endocrine Response in Women With Invasive Lobular Breast Cancer

Priscilla McAuliffe 2015. "Endocrine Response in Women With Invasive Lobular Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02206984.

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