Comparing Oral Tamoxifen, TamGel, and No Treatment in Women at Higher Risk of Breast Cancer

Sponsor: Amy C. Degnim

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT04570956

Provider View

This study is exploring how breast tissue changes after a short course of Tamoxifen, either taken as a pill or applied as a gel, in women with certain breast conditions that increase their risk of developing breast cancer.

Patient Parameters

Program Overview

The study aims to understand how a short course of Tamoxifen, either in pill form or as a gel, affects breast tissue in women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS), both of which increase the risk of breast cancer. Researchers want to see if these treatments can change early markers in breast tissue that might indicate a response to the therapy. The study will compare the effects of low-dose oral Tamoxifen and a topical gel form of Tamoxifen to see which is more effective and has fewer side effects.

Description

Women with certain breast conditions like atypical hyperplasia (AH) and lobular carcinoma in situ (LCIS) have a higher risk of developing breast cancer. Tamoxifen, a medication taken orally, has been shown to reduce this risk significantly. However, the side effects of the standard dose can be a barrier for many women. This study is testing two alternative approaches: a lower dose of oral Tamoxifen and a topical gel form, to see if they can provide the same benefits with fewer side effects. Participants will take a short course of one of these treatments, and researchers will examine breast tissue samples before and after the treatment to look for early signs of response. The goal is to find a safer and more acceptable way to reduce breast cancer risk in women with AH or LCIS.

Eligibility Criteria

Inclusion Criteria

  • Willing to return for follow-up visits and complete necessary tests.
  • Able to fill out a questionnaire independently or with help.
  • Female, as assigned at birth.
  • Have a confirmed diagnosis of atypical ductal or lobular hyperplasia, or lobular carcinoma in situ (LCIS) within the last year, or have an increased risk of breast cancer based on specific risk models.
  • Good overall health with a performance status score of 0 or 1.
  • Women of childbearing potential must use effective birth control during the study and for two months after, and have a negative pregnancy test before starting the study.
  • Agree to avoid sun exposure on the breast area during the study.
  • Have acceptable organ and marrow function as determined by the study doctor.
  • Negative pregnancy test if of childbearing potential.

Exclusion Criteria

  • Have a suspicious breast mass or lesion.
  • Had breast cancer in the past five years.
  • History of blood clots.
  • Currently pregnant or breastfeeding.
  • Have had specific breast cancer treatments in the past two years.
  • Used certain hormone therapies or medications affecting estrogen in the past five years, with some exceptions.
  • Used oral contraceptives within one month before the study.
  • Have had radiation therapy to the same breast.
  • Have skin conditions on the breast.
  • History of endometrial cancer.
  • Currently smoking.
  • Using medications that interfere with Tamoxifen.
  • Have allergies to Tamoxifen.
  • Have uncontrolled health issues that would affect participation.
  • Taking blood thinners.
  • Have low blood counts or abnormal liver or kidney function tests.
  • Taking medications that affect how Tamoxifen works.
  • Have heart rhythm issues requiring medication.
  • Have a suspicious mass on examination.

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