DCIS Pre-operative
- A PILOT PRE-OPERATIVE WINDOW TRIAL OF BLACK-COHOSH IN WOMEN WITH DUCTAL CARCINOMA IN SITU(DCIS) (BLACK COHOSH)
Treatment Inclusion Criteria Exclusion Criteria Initial Surgical Consultation for DCIS → 2-5 week course of Black Cohosh → Definitive excision of DCIS 1. DCIS histologically confirmed on breast core biopsy
2. ECOG performance status 0-1
3. Willing to schedule definitive resection of DCIS 2-5 weeks after study enrollment
1. Lactose intolerance, lactose allergy or salicylate allergy
2. Patients who have already undergone excisional biopsy for qualifying DCIS
3. Ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study
4. Receiving any other chemotherapy or investigational agents
5. Serious concomitant systemic disorders (including active infections) or psychiatric illness/social situations.
6. Lab Evaluation: • Liver function tests ≥ 2 times the institutional upper limits of normal • Creatinine > 1.5 x IULN • ANC < 1,500 /µL • Platelets < 100,000 /µL
7. Allergic reactions to compounds of similar chemical or biologic composition of black cohosh
8. The effects of black cohosh on fetus at the recommended therapeutic dose are unknown. So, women of child-bearing potential must agree to use adequate contraception for the duration of study participation.
9. Prior/concurrent therapy including:
a. Tamoxifen, raloxifene, letrozole, anastrozole, or exemestane in the past 6 months
b. Chemotherapy, biologic therapy (e.g., trastuzumab), or breast radiotherapy to the breast currently affected by DCIS within the past 12 months
c. Any exogenous hormonal therapy including estrogen-, progesterone-, and/or androgen-based agents in the past 6 months
d. Phytoestrogens or OTC medications with estrogenic or androgenic properties in the past 6 months
e. Any black cohosh preparation within the past 6 months
HIC:1205010204