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Project Title Low Dose Tamoxifen Breast Cancer Prevention Study

Researcher Melanie Palomares, MD, MS, City of Hope; Sofia Merajver, MD, PhD, University of Michigan; Melissa Hudson, MD, St. Jude Children's Research Hospital; Ruth O'Regan, MD, Emory University; David Hodgson, Princess Margaret Hospital

Study Summary The purpose of this study is to determine the effectiveness of two years of low-dose tamoxifen on breast density and other biological markers (biomarkers) associated with increased breast cancer risk in female childhood, adolescent, and young adult cancer survivors treated with chest or axilla radiation by the age of 40. The study is also measuring the safety and tolerability of tamoxifen at the lower dose. This will be determined by laboratory test results and questionnaires on side effects.

Who Can Participate? You can join the Low Dose Tamoxifen Breast Cancer Prevention Study if you match ALL of these MAIN categories:

• You are a woman 25 years of age or older
• You were diagnosed with a childhood, adolescent or young adult cancer two or more years ago
• You received radiation to the chest or axilla by age of 40
• You remained recurrence-free for at least two years
• You do NOT have a history of invasive breast cancer (if you have been diagnosed with DCIS, also known as noninvasive or Stage 0 breast cancer, you may still be eligible to join)
• You do NOT have breast implants
• You live near or are willing to travel (at your own expense) to one of the following study sites:
o City of Hope, a comprehensive cancer center in Duarte, California
o University of Michigan, Ann Arbor, MI
o St. Jude Children's Research Hospital, Memphis, TN
o Emory University, Atlanta, GA
o Princess Margaret Hospital, Toronto, Ontario, Canada

After you RSVP, the research team will ask you additional questions to be sure that this study is the right fit for you.

What Does Participation Involve? If you sign up for the Low Dose Tamoxifen Breast Cancer Prevention Study, the research team will contact you by phone to ask additional screening questions. If you appear to be eligible and agree to participate, you will schedule an appointment for a 1-2 hour screening visit at one of the participating clinics (located closest to you) to:

• Complete a medical history, breast exam, and blood tests
• Provide permission for study staff to review your medical records from when your cancer was diagnosed and treated with radiation

If you are eligible and choose to join the study:
• You will be given pills containing either a placebo (sugar pill) or 5mg of tamoxifen to take daily for two years.

• You will be evaluated quarterly, including:
o Phone call visits every 3 months to check on how you are doing.
o In person clinic visits every 6 months for a breast exam and to complete questionnaires.
o In person clinic visits every year for blood and urine tests, mammogram, and to complete questionnaires.

• Breast tissue sampling may be performed at the beginning and at the end of the study.

Please note that you cannot take hormonal contraceptives (any form, including pill, implant, IUD, etc.) or have fertility treatments while you are enrolled in this study. You must use another form of contraceptive (such as a condom or diaphragm) and you cannot become pregnant or be nursing while you are enrolled in this study.

Additionally, you cannot use hormone replacement therapy (any form, including pill, patch, cream, etc.) while you are enrolled in this study. You are allowed to use Vagifem® or Estring® while on this study.

The researcher need to enroll up to 230 women in this study.

Where? City of Hope, a comprehensive cancer center in Duarte, California; University of Michigan, Ann Arbor, MI; St. Jude Children's Research Hospital, Memphis, TN; Emory University, Atlanta, GA; and Princess Margaret Hospital, Toronto, Ontario, Canada