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.

Inclusion criteria

• A patient/subject is eligible for enrollment if all of the following inclusion criteria are met:

• Pre- and post-menopausal women ≥ 18 years of age newly diagnosed with DCIS histologically confirmed on breast core biopsy
• Ability to understand and the willingness to sign a written informed consent document
• ECOG performance status 0-1
• Life expectancy >12 months
• Willing to schedule definitive resection of DCIS 4 weeks +/- 1 week after study enrollment
• Original breast core biopsy specimen available for pathologic review and staining by Yale School of Medicine Department of Pathology

Exclusion criteria

• A patient /subject will not be eligible for this study if any of the following exclusion criteria are met:

• Pregnant or nursing within past 6 months
• Lactose intolerant, lactose allergy or salicylate allergy
• Patients who have already undergone excisional biopsy for qualifying DCIS
• Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study
• Patients receiving any other chemotherapy or investigational agents
• Serious concomitant systemic disorders (including active infections) or psychiatric illness/social situations that would compromise the safety of the patient or compromise the patient's ability to complete the study, at the discretion of the investigator.
• Liver function tests ≥ 20% of the institutional upper limits of normal
• Creatinine > 1.5 times the institutional upper limit of normal
• ANC < 1,500 /µL
• Platelets < 100,000 /µL
• History of allergic reactions attributed to compounds of similar chemical or biologic composition to black cohosh
• The effects of black cohosh on the developing human fetus at the recommended therapeutic dose are unknown. For this reason, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately.
• Prior/concurrent therapy including:

Tamoxifen, raloxifene, letrozole, anastrozole, or exemestane in the past 6 months

• Chemotherapy, biologic therapy (e.g., trastuzumab [Herceptin®]), or breast radiotherapy to the breast currently affected by DCIS within the past 12 months
• Any exogenous hormonal therapy including estrogen-, progesterone-, and/or androgen-based agents in the past 6 months
• Phytoestrogens or OTC medications with estrogenic or androgenic properties in the past 6 months
• Any black cohosh preparation within the past 6 months