A Phase IIB Study Comparing Oral versus Topical Tamoxifen for Ductal Carcinoma In Situ (DCIS) of the Breast

Full Title

Phase IIB Trial of Neoadjuvant Oral Tamoxifen Versus Transdermal 4-hydroxytamoxifen in Women with DCIS of the Breast (CIRB)

Purpose

Ductal carcinoma in situ (DCIS) is a form of breast cancer in which cancer cells are confined to the milk ducts. It is usually treated with surgery and sometimes radiation therapy. Patients with estrogen receptor (ER)-positive DCIS may also receive tamoxifen for five years after surgery, which they take by mouth, but it can cause uncomfortable side effects because it travels throughout the bloodstream to all parts of the body.

In this study, researchers want to see if a “broken-down” form of tamoxifen, called 4-OHT, applied in a gel to the breast skin is as effective for preventing DCIS recurrence as oral tamoxifen. Patients will be randomly assigned to one of two groups:

  • One group will apply 4-OHT gel and take a placebo (inactive) capsule each day.
  • The other group will apply a placebo gel and take a tamoxifen capsule each day.

Patients will apply the gel and take the capsule for 6-10 weeks before DCIS surgery. It is hoped that the gel is as effective as the capsule, but associated with fewer side effects.

Eligibility

To be eligible for this study, patients must meet several criteria, including but not limited to the following:

  • Patients must have ER-positive DCIS that has not yet been treated.
  • Patients must be asymptomatic (no nipple discharge or a mass that can be felt).
  • Patients must be physically well enough that they are fully ambulatory, capable of all self care, and able to perform moderately strenuous activities.
  • This study is for patients age 18 and older.

For more information about this study and to inquire about eligibility, please contact Dr. Melissa Pilewskie at 646-888-4590.

Protocol

18-047

Phase

II

Disease Status

Newly Diagnosed & Relapsed/Refractory

Investigator

Co-Investigators

Diseases