Testing a Skin-Delivered Form of Tamoxifen for Treating Ductal Carcinoma in Situ (DCIS) of the Breast

Sponsor: Northwestern University

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT02993159

Provider View

This study is exploring whether a gel form of tamoxifen, applied to the skin, is as effective as the oral form in treating a type of breast cancer called ductal carcinoma in situ (DCIS). The trial aims to see if this method can block estrogen, which helps cancer cells grow.

Patient Parameters

Program Overview

This clinical trial is testing if a gel form of tamoxifen, applied directly to the skin, can effectively treat ductal carcinoma in situ (DCIS) of the breast, a type of non-invasive breast cancer. The study compares the gel to the traditional oral tamoxifen to see if it can block estrogen, which fuels the growth of cancer cells, just as well. Participants will be randomly assigned to use either the gel or the oral form for 4 to 10 weeks, and their progress will be monitored through various tests and follow-up visits.

Description

The main goal of this study is to find out if applying a tamoxifen gel to the skin can reduce cancer cell activity in DCIS as effectively as taking tamoxifen pills. Researchers will measure changes in cancer cell activity by comparing tissue samples taken before and after treatment.

Secondary goals include comparing changes in certain cancer-related markers and breast tissue density between the two treatment groups. The study will also look at the levels of tamoxifen and its breakdown products in the body, as well as changes in hormone levels and blood proteins related to blood clotting.

Participants will be divided into two groups. One group will apply the tamoxifen gel to their breasts and take a placebo pill daily. The other group will apply a placebo gel and take tamoxifen pills daily. Both treatments will last for 4 to 10 weeks, unless there are side effects or the cancer progresses.

After finishing the treatment, participants will have follow-up visits 1 to 2 weeks and 1 month after surgery to monitor their health and the treatment's effects.

Eligibility Criteria

Inclusion Criteria

  • Diagnosed with estrogen receptor positive DCIS of the breast through a biopsy.
  • Good overall health with a performance status score of 0 or 1.
  • Adequate blood cell counts and organ function based on specific lab tests.
  • Women of childbearing potential and their male partners must use two effective forms of birth control during the study and for two months after.
  • Willing to avoid sun exposure on the breast skin during the study.
  • Able to understand and sign a consent form.

Exclusion Criteria

  • DCIS that can be felt as a lump.
  • Use of hormone medications within 4 weeks before the biopsy.
  • Previous radiation treatment for breast cancer on the same side.
  • Skin conditions on the breast that break the skin surface.
  • History of certain cancers or blood clotting disorders.
  • Current smokers.
  • Use of medications that interfere with tamoxifen unless they can be safely stopped.
  • Previous use of certain breast cancer prevention drugs within 5 years.
  • Participation in another clinical trial within 30 days before this study.
  • Allergies to tamoxifen or similar drugs.
  • Serious health conditions that could interfere with the study.
  • Pregnant or breastfeeding women.
  • Men are not eligible for this study.

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