Tamoxifen for Breast Cancer Risk after Radiation Therapy (LDTam Trial)

Recruiting in Palo Alto (17 mi)

+12 other locations

Overseen BySmita 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.

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.

I am 45 or younger and have had regular periods for the last 6 months.

Exclusion Criteria

My cervical cancer has not spread beyond my cervix.

I have breast implants or have had both breasts removed as a preventive measure.

I have a non-invasive breast condition.

My bladder cancer is on the surface and has not spread deeply.

I am unable to give my consent.

I have a type of skin cancer that is not melanoma.

I am not taking warfarin or strong CYP2D6 inhibitors together.

Participant Groups

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.

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (tamoxifen citrate)Experimental Treatment10 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 Group10 Interventions

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