Tamoxifen for Breast Cancer Risk after Radiation Therapy

(LDTam Trial)

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen by Smita Bhatia, MD

Age: 18+

Sex: Female

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: University of Alabama at Birmingham

Prior Safety Data

Trial Summary

What is the purpose of this trial?

Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors.

Research Team

Smita Bhatia, MD

Principal Investigator

University of Alabama at Birmingham

Eligibility Criteria

This trial is for radiation-induced cancer survivors who are at risk of breast cancer, have had chest radiation therapy by age 40, and have been disease-free for 2 years. Postmenopausal women or premenopausal women under 45 with regular periods can join. Exclusions include those with certain other cancers, recent hormone treatments, pregnancy plans within two years, or a history of blood clots.

Inclusion Criteria

I received radiation therapy in the chest area or total body irradiation of 12 Gy or more by age 40.

You have not had a period for 12 months, had surgery to remove both ovaries, or have a specific hormone level indicating you are postmenopausal.

My menopausal status is clearly defined.

Exclusion Criteria

I have signs of breast cancer on imaging but may continue if it's benign.

I have used hormone therapy or certain vaginal estrogen products recently.

Your SGOT or SGPT levels are more than double the normal range at the medical center.

Treatment Details

Interventions

• Tamoxifen Citrate (Selective Estrogen Receptor Modulator)

Trial Overview The study tests if low-dose tamoxifen citrate can reduce the risk of developing breast cancer in individuals previously treated with chest radiation. It involves comparing tamoxifen to a placebo and includes various assessments like mammography and questionnaires about quality of life.

Participant Groups

Group I: Arm I (tamoxifen citrate) Experimental Treatment 10 Interventions

Patients receive tamoxifen citrate PO QD for 24 months in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (placebo) Placebo Group 10 Interventions

Patients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity.

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

St. Jude Children's Research Hospital Memphis, TN

Seattle Cancer Care Alliance Seattle, WA

MD Anderson Houston, TX

University Health Network, Toronto Toronto, Canada

More Trial Locations

Who Is Running the Clinical Trial?

University of Alabama at Birmingham

Lead Sponsor

Trials

1,677

Recruited

2,458,000+

Kierstin Kennedy

University of Alabama at Birmingham

Chief Medical Officer since 2022

MD

S. Dawn Bulgarella

University of Alabama at Birmingham

Chief Executive Officer since 2023

BSc in Commerce and Business Administration from the University of Alabama, MS in Health Administration from the University of Alabama at Birmingham

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Dr. Timothy H. Dellit

University of Washington

Chief Executive Officer since 2023

MD from University of Washington

Dr. Anneliese Schleyer

University of Washington

Chief Medical Officer since 2023

MD, MHA

City of Hope National Medical Center

Collaborator

Trials

17

Recruited

8,900+

University of Chicago

Collaborator

Trials

1,086

Recruited

844,000+

Pete Salzmann

University of Chicago

Chief Executive Officer since 2018

MD from University of Chicago’s Pritzker School of Medicine, MBA from Stanford University’s Graduate School of Business

Anh Nguyen

University of Chicago

Chief Medical Officer

MD from Rutgers New Jersey Medical School, MBA from University of Chicago

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School

St. Jude Children's Research Hospital

Collaborator

Trials

451

Recruited

5,326,000+

Dr. James R. Downing

St. Jude Children's Research Hospital

Chief Executive Officer since 2014

MD from University of Michigan Medical School

Dr. Ellis J. Neufeld

St. Jude Children's Research Hospital

Chief Medical Officer since 2017

MD, PhD from Harvard Medical School

University Health Network, Toronto

Collaborator

Trials

1,555

Recruited

526,000+

Dr. Brad Wouters

University Health Network, Toronto

Chief Medical Officer since 2020

MD from University of Toronto

Dr. Kevin Smith

University Health Network, Toronto

Chief Executive Officer since 2018

Professor at McMaster University and University of Toronto

University of Michigan

Collaborator

Trials

1,891

Recruited

6,458,000+

Marschall S. Runge

University of Michigan

Chief Executive Officer since 2015

MD, PhD

Karen McConnell

University of Michigan

Chief Medical Officer since 2020

MD

Mayo Clinic

Collaborator

Trials

3,427

Recruited

3,221,000+

Dr. Gianrico Farrugia

Mayo Clinic

Chief Executive Officer since 2019

MD from University of Malta Medical School

Dr. Richard Afable

Mayo Clinic

Chief Medical Officer

MD from Loyola Stritch School of Medicine

Dana-Farber Cancer Institute

Collaborator

Trials

1,128

Recruited

382,000+

Dr. Benjamin L. Ebert

Dana-Farber Cancer Institute

Chief Executive Officer

MD from Harvard Medical School, PhD from Oxford University

Dr. Craig A. Bunnell

Dana-Farber Cancer Institute

Chief Medical Officer since 2012

MD from Harvard Medical School, MPH from Harvard School of Public Health, MBA from MIT Sloan School of Management