LDTAM: Low-Dose Tamoxifen Citrate in Reducing Breast Cancer Risk in Radiation-Induced Cancer Survivors

Low-dose Tamoxifen in Hodgkin Lymphoma Survivors for Breast Cancer Risk Reduction: A Phase IIB Randomized Placebo-Controlled Trial

Categories:

Long-term Effects

Phase I/II

Leukemia / Lymphoma

Diseases Treated:

For survivors of Hodgkin lymphoma

Eligibility Overview:

  • Females, 25 years of age or older.
  • Participant does not plan to become pregnant in the next 2 years and is not currently breast feeding.

Description

Hodgkin lymphoma — formerly known as Hodgkin's disease — is a cancer of the lymphatic system, which is part of your immune system. Patients with Hodgkin lymphoma are typically treated with radiation, which has led to high survivorship. However, it has been found that Hodgkin lymphoma patients who received radiation to the chest area before age 30 have up to a 55 times higher risk of developing breast cancer than the average woman.

Tamoxifen has been successfully used in the treatment of breast cancer for about 40 years, and has been shown to help prevent new cancers from occurring. This study is going to test a two-year course of tamoxifen at the 5 mg daily dose in female Hodgkin lymphoma survivors to see if it will have the same effects as shown prior studies. If so, low-dose tamoxifen (5 mg per day) may be a good option for decreasing breast cancer risk in women who received chest radiation, with fewer side effects.

Objectives

  • To learn whether a 2 year course of low dose tamoxifen (5mg daily) decreases breast density on mammograms and decreases certain markers in the blood which are associated with the risk of breast cancer in women who were treated with chest radiation at a young age for Hodgkin lymphoma.
  • To measure the safety and tolerability of tamoxifen according to laboratory tests and information on side effects collected from questionnaires.

Eligibility

  • Females, 25 years of age or older.
  • Participant does not plan to become pregnant in the next 2 years and is not currently breast feeding.

Contact

Melissa Hudson, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.