A Pilot Pre-Operative Window Trial of Black Cohosh in Women with Ductal Carcinoma in situ

Trial Purpose and Description

Trial Purpose

This research study is designed to look at whether or not Black Cohosh, an herbal, over the counter medication, is an effective treatment for early breast cancer. There are many different preparations of Black Cohosh available over the counter. For this study, we will use the Remifemin® formulation of Black Cohosh.

Participation Guidelines

Eligibility Criteria

5.1 Inclusion Criteria

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

5.1.1    Pre- and post-menopausal women ≥ 18 years of age newly diagnosed with DCIS histologically confirmed on breast core biopsy

5.1.2    Ability to understand and the willingness to sign a written informed consent  document

5.1.3.   ECOG performance status 0-1

5.1.4    Life expectancy >12 months

5.1.5   Willing to schedule definitive resection of DCIS 4 weeks +/- 1 week after study

            enrollment

5.1.6    Original breast core biopsy specimen available for pathologic review and staining

             by Yale School of Medicine Department of Pathology

5.2 Exclusion Criteria

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

5.2.1    Pregnant or nursing within past 6 months

5.2.2        Lactose intolerant, lactose allergy or salicylate allergy

5.2.3        Patients who have already undergone excisional biopsy for qualifying DCIS

5.2.4        Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study

5.2.5        Patients receiving any other chemotherapy or investigational agents

5.2.6        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.

5.2.7        Liver function tests  ≥20% of the institutional upper limits of normal

5.2.8        Creatinine > 1.5 times the institutional upper limit of normal

5.2.9        ANC < 1,500 /µL

5.2.10    Platelets < 100,000 /µL

5.2.11    History of allergic reactions attributed to compounds of similar chemical or biologic composition to black cohosh

5.2.12    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.

5.2.13    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

Sponsor:

American Cancer Society

Yale Cancer Center

Dates:

June 2012

Last Updated:

Study HIC#:

1205010204

Clinicaltrials.gov ID: Yale9799114