A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
The overarching hypothesis of our research is that black cohosh has potential to be a
well-tolerated, effective agent for the treatment of early breast cancer. This pilot study
represents a first step in exploring this hypothesis by demonstrating preliminary evidence
of specific anti-tumor effect of black cohosh on areas of ductal carcinoma in situ (DCIS) in
the breast.
Interventional
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Measure change in size of DCIS on routine imaging
Measure change in size of DCIS on routine imaging (i.e. mammography and/or ultrasound) obtained before and after 4 weeks of treatment with black cohosh, with correlation to specimen sizes; and Determine differences in breast epithelial cell proliferation in areas of DCIS as measured by mean change in levels of Ki67 before and after 4 weeks of treatment with black cohosh. Ki67 levels will be assessed with traditional immunohistochemical staining as well as AQUA technology.
4 weeks
No
Erin Hofstatter, MD
Principal Investigator
Yale University
United States: Food and Drug Administration
EH0524BlackCohosh
NCT01628536
June 2012
June 2013
Name | Location |
---|---|
Erin Hofstatter, MD | New Haven, Connecticut 06510 |