Trial of 4-Hydroxytamoxifen (4-OHT) Gel in Women Aimed at Reducing Dense Breast Tissue (NCT03199963) | Clinical Trial Compass
TerminatedPhase 3
Trial of 4-Hydroxytamoxifen (4-OHT) Gel in Women Aimed at Reducing Dense Breast Tissue
Stopped: Administrative - change in development strategy
United States223 participantsStarted 2017-08-21
Plain-language summary
A study to determine the efficacy of 8 mg/day (4 mg/breast) of BHR-700 gel compared to placebo for reducing breast tissue density in women identified as having dense breast tissue upon analysis of screening mammography. The Primary Study Endpoint being the percent reduction of mammographic breast tissue density on a follow-up mammogram compared to the baseline mammogram after 52 weeks of treatment.
Who can participate
Age range35 Years – 75 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
✓. If the participant is of childbearing potential, she must have a documented negative urine pregnancy test at the time of screening and randomization and no plans to become pregnant for the duration of study participation.
✓. Ability to understand and the willingness to sign a written informed consent document.
Exclusion criteria
✕. Participants may not be receiving treatment with any investigational drug or biologic within 30 days of randomization or at any time during the study.
✕. Women with a history of allergic reactions attributed to compounds of similar chemical or biologic composition to Tamoxifen.
✕. Pregnant women are excluded from this study because the effects of 4-OHT gel on the developing human fetus at the recommended dose and route are unknown.
What they're measuring
1
The Percent Reduction of Mammographic Dense Breast (MBD) Tissue on a Follow-up Mammogram Compared to the Baseline Mammogram After 52 Weeks of Treatment.
. Pregnancy (independent of outcome) and/or lactation within 1 year prior to the screening mammogram.
✕. Women with previous history of cancer (including invasive or intra-ductal breast cancer) except for non-melanoma skin cancer.
✕. Women who have had a prior mastectomy (unilateral or bilateral), segmental mastectomy, reduction mammoplasty or breast augmentation including implants.
✕. Women with surgical breast biopsy(s) performed within 3 years or core biopsy(s) performed within 1 year prior to the screening mammogram.
✕. Women with an abnormal mammogram (BI-RADS final assessment category 3-probably benign, 4-suspicious, or 5-malignant findings). Women with BI-RADS 0 assessment (needs additional imaging evaluation) that are subsequently found to have negative (BI-RADS 1) or benign findings (BI-RADS 2), are NOT excluded.