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Protocol No. MDA20160702

Principal Investigator Wilke, Lee

Phase II (Cancer Prevention)

Age Group Adult

Scope National

Sponsor Type Externally Peer-Reviewed

Title A Randomized, Double-blind, Placebo-controlled Study of 4-hydroxytamoxifen Topical Gel in Women with Mammographically Dense Breast

Objective The goal of this study is to determine whether putting 4-OHT gel on the breast skin lowers MD compared with putting placebo gel on the breast skin. The placebo gel looks like the 4-OHT gel but does not contain study medication. 4-OHT gel is an investigational drug, meaning that it has not been approved by the FDA. It has been used in previous clinical trials in women with breast cancer, ductal carcinoma in situ (DCIS), and breast pain

Treatment In this study, you will be randomized to receive one of two types of topical gel.
  • Group 1 will receive 4-hydroxytamoxifen topical gel: participants in this group will apply 2 mg of 4-hydroxytamoxifen topical gel to each breast, pushing the pump one time for each breast application, once a day
  • Group 2 will be the “comparison group”: participants in this group will apply placebo gel to each breast, pushing the pump one time for each breast application once a day.

  • Description A Randomized, Double-blind, Placebo-controlled Study of 4-hydroxytamoxifen Topical Gel in Women with Mammographically Dense Breast

    Key Eligibility
  • Women age 40-69 years, or less than 40 years if 5-year breast cancer Gail risk is greater than or equal to 1.66%
  • Mammographically dense breast (heterogeneously dense (C) or extremely dense (D), based on ACR BIRADS fifth edition classification or heterogeneously dense (3) or extremely dense (4), based on ACR BIRADS fourth edition classification) in either breast
  • ECOG performance status less than or equal to 1 (Karnofsky greater than or equal to 70%)
  • Normal organ and marrow function as defined by the protocol
  • Must have a gynecology examination within the last 5 years (gynecology examination is not required if participant had a hysterectomy)
  • Premenopausal women using a hormonal or non-hormonal Intra-Uterine Device (IUD) birth control method will be eligible, if they have been on the same IUD for at least 3 months prior to enrollment and plan to continue using the same method throughout the study
  • Women who are using postmenopausal hormones, and are planning to continue the same regimen through the study intervention are eligible to participate
  • Willingness to avoid exposing breast skin to natural or artificial sunlight (i.e. tanning beds) for the duration of the study
    EXCLUSION
  • History of allergic reactions attributed to compounds of similar chemical or biologic composition to 4-OHT gel
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection,symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia,thromboembolic disease, or psychiatric illness/social situations that would limit compliance with study requirements
  • Pregnant or breastfeeding
  • Previous history of invasive breast cancer or bilateral DCIS or current untreated DCIS. Women with a history of cancer within the last 3 years, except for non-melanoma skin cancer. Women with unilateral DCIS (with or without radiation therapy) are eligible as long as they have an unaffected breast
  • Prior bilateral breast surgery (mastectomy, segmental mastectomy, or breast augmentation surgery including breast implants or breast reductions)
  • Women with "mosaic mammographic screening views", i.e., whose larger breast size precludes being imaged within a single mammographic screening view
  • Women with active liver disease
  • Women with a uterus and abnormal uterine bleeding, or prior diagnosis of endometrial hyperplasia, endometrial polyps, or endometrial cancer
  • Prior use of SERMS and AIs, except for a maximum of 3 months and at least 12 months prior
  • Skin lesions on the breast that disrupt the stratum corneum (e.g., eczema, ulceration)

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions UW Hospital and Clinics