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STUDY BASICS

Are you an adult female diagnosed with estrogen-receptor-positive/HER2-negative breast cancer? Did your cancer stop responding to treatment and has it reoccurred or spread? If so, you may be able to participate in a research study to help learn more about the effects of fulvestrant and lasofoxifene in women with advanced breast cancer who have received prior treatment.


STUDY PURPOSE

Many women with estrogen-receptor-positive, HER2-negative breast cancers are treated with a combination of aromatase inhibitors and CDK4/6 inhibitors, but the cancer often stops responding to these treatments and progresses over time. Advanced breast cancer that has reoccurred or spread to other parts of the body or can be difficult to treat. The purpose of this research study is to learn more about the effects of an FDA-approved drug called fulvestrant and an experimental drug called  lasofoxifene on women with advanced breast cancer who have received prior treatment.

 
 

COULD THIS STUDY BE RIGHT FOR YOU?
  • Females ages 18 and up
  • Diagnosed with estrogen-receptor-positive/HER2-negative breast cancer
  • Breast cancer has stopped responding to treatment and has reoccurred or spread
 
 

WHAT PARTICIPANTS CAN EXPECT

This study involves multiple visits over about one year. In order to qualify for the study, participants will have an initial blood test to find out if their breast cancer has a specific genetic change called an ESR1 mutation. Eligible participants with an ESR1 mutation will be randomly assigned (like the flip of a coin) to receive either  fulvestrant or lasofoxifene, and will also have blood draws, physical exams, CT or MRI scans, electrocardiograms (ECG), and other tests and assessments. After treatment, participants will have one follow-up visit and a follow-up phone call every 6 months.

 

IRB:
  20183338 - An Open-label, Randomized, Multicenter Study Evaluating the Activity of Lasofoxifene Relative to Fulvestrant for the Treatment of Pre- and Postmenopausal Women with Locally Advanced or Metastatic ER+/HER2− Breast Cancer with an ESR1 Mutation

RESEARCH AREAS:
  Women's Health

Age Range
AGE:   18 and up

 
Gender List
SEX ASSIGNED AT BIRTH:   Female

Duration DURATION:  12 months
VISITS:  Multiple

Location LOCATION: 
Various UPMC Locations
Compensation COMPENSATION: 

NONE

Phone Number PHONE NUMBER:
1-866-438-8230
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Phone Number PHONE NUMBER:
1-866-438-8230

MEET THE RESEARCHER


Adam Brufsky

Adam M. Brufsky, MD, PhD, is Associate Chief and Professor of Medicine in the Division of Hematology/Oncology in the Department of Medicine at the University of Pittsburgh and Associate Director of Clinical Investigation for the University of Pittsburgh Cancer Institute. Dr. Brufsky received his medical degree and doctorate from the University of Connecticut School of Medicine. He completed his residency in internal medicine at Brigham and Women's Hospital, Harvard Medical School and a fellowship in medical oncology and bone marrow transplantation at the Dana-Farber Cancer Institute.  Dr. Brufsky’s research interests include novel therapies for breast cancer, bone-breast cancer interactions and therapeutics, and the molecular biology of metastatic breast cancer.




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