Clinical Trial: Endocrine Response in Pre-Surgical ILC Patients

Postmenopausal women who have been diagnosed with invasive lobular breast cancer (ILC) who have not yet had surgery to remove their tumor may be eligible to participate in a multi-site clinical trial.

This clinical trial will compare how lobular breast tumors respond to three different commonly prescribed, effective medications that are currently being used to treat breast cancer.  The goal of the trial is to study how the lobular breast tumors may respond differently to these medications (known as endocrine or hormonal therapies).  Results of this study can help refine treatments for patients with lobular breast cancer in the future.

Name of the Trial:  A Trial of Endocrine Response in Women with Invasive Lobular Breast Cancer

Who might qualify?  Patients with early stage Invasive Lobular Breast Cancer, who are post-menopausal (no longer get their period) and who have not yet had surgery to remove their tumor may qualify for the study

Where can patients enroll?  This trial is currently enrolling patients in Birmingham AL; San Francisco, CA; Indianapolis, IN; Rochester MN; New York NY; Houston TX; Pittsburgh PA, Chapel Hill NC and Seattle WA

What happens in this trial?  Patients will be randomly assigned to one of three groups.  Each group will receive a different commonly used breast cancer medication for 21 days prior to their surgery (Tamoxifen, Anestrozole or Fulvestrant).  These medications are all proven to be effective therapies against breast cancer.  Researchers will analyze the effect of each medication on the tumor to learn how and why which medication might be most effective to treat lobular breast cancer.

Why is this study beneficial?  In traditional breast cancer treatment for lobular breast cancer, patients with estrogen positive (ER+) breast cancer are often given endocrine therapy medications after surgery and other treatment is completed.   Giving the medications for a short window of time as a patient is prepared for surgery allows researchers to measure the impact of these therapies on key tumor features to learn which of these commonly prescribed medications is most effective for ILC.  Patients will receive medications in the window of time while they wait for their surgery.

How to learn more about whether participating in this clinical trial is right for you.

  1. Read more about the trial at the ClinicalTrials.gov 
  2. Discuss this trial with your doctor. Questions to ask your doctor from the National Institutes of Health can help.

Principle Investigator and Responsible Researcher:  Rachel C. Jankowitz, MD (University of Pittsburgh)

Overall Clinical Trial Contact:

Brenda L Steele, BSN, RN    412-641-3418         Steebx@upmc.edu
Rometa R Pollard, BS           412-641-5430        Pollardrr@upmc.edu
ClinicalTrials.gov Identifier: NCT02206984

Trial Locations and Contacts

Birmingham, Alabama

UAB Comprehensive Cancer Center
Contact: Erica M Reasor-Stringer, MD       205-934-3411      strinem@uab.edu
Contact: Liz Busby, RN, BSN                        205-934-0337      lizbusby@uab.edu

San Francisco, California

University of California, San Francisco

Contact:  Rita Mukhtar, MD                          415 353 7908        Rita.Mukhtar@ucsf.edu

Indianapolis, Indiana

IU Simon Cancer Center
Contact: Anna M Storniolo, MD                312-278-7576         stornio@iu.edu
Contact: Tammi Detty, CCRP                     317-278-6227        tmdetty@iupui.edu

Rochester, Minnesota

Mayo Clinic
Contact: Tina Hieken, MD                          855-776-0015        Hieken.Tina@mayo.edu
Contact: Kim Hitchcock                               507-266-3867       hitchcock.kim@mayo.edu

New York, New York (Bronx)

Albert Einstein College of Medicine,  Montefiore Medical Center
Contact: Joseph Sparano, MD                  718-405-8404         JSPARANO@montefiore.org
Contact: Vilma Calderon, RN                                                      VCALDERO@montefiore.org

Chapel Hill, North Carolina

University of North Carolina at Chapel Hill
Contact: Kristalyn Gallagher, DO    919-966-5221      kristalyn_gallagher@med.unc.edu
Contact: Rachel Phipps, RN

Pittsburgh, Pennsylvania

Magee Womens Hospital of UPMC
Contact: Brenda L Steele, BSN, RN         412-641-3418          Steebx@upmc.edu

Houston, Texas

University of Texas MD Anderson Cancer Center
Contact: Alastair Thompson, MD     713-745-2792            athompson1@mdanderson.org
Contact: Jaime Crow, MS                   717-792-6443            jrcrow@mdanderson.org

Seattle, Washington

Univ. of Washington, Seattle Cancer Care Alliance, Fred Hutchinson Cancer Research Center
Contact: Hannah Linden, MD                206-288-1234          hmlinden@seattlecca.org
Contact: Obsy Tadesse                             206-288-6831          otadesse@seattlecca.org

The Lobular Breast Cancer Alliance shares information about ongoing clinical trials for patients with lobular breast cancer.  LBCA does not sponsor or run the clinical trials, and the scientific validity and safety of the trials is the responsibility of the trial investigators.  Patients should always discuss their participation in any clinical trial directly with their doctor and learn more by contacting the clinical trial coordinators listed above directly.  Learn more about participating in clinical trials.