Clinical trial NCT01628536: A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
Official title: A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Ductal Carcinoma in Situ
Keywords: Black Cohosh
Ductal Carcinoma in situ
Breast Cancer
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2012-06-26
Enrollment: 33
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The investigators hypothesize that black cohosh, as a potentially therapeutic agent, will reduce the overall size and aggressiveness of ductal carcinoma in situ (DCIS) when given in a pre-operative setting.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

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

  1. Pre- and post-menopausal women ≥ 18 years of age newly diagnosed with DCIS histologically confirmed on breast core biopsy
  2. Ability to understand and the willingness to sign a written informed consent document
  3. ECOG performance status 0-1
  4. Life expectancy \>12 months
  5. Willing to schedule definitive resection of DCIS 4 weeks +/- 1 week after study enrollment
  6. 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:

  1. Pregnant or nursing within past 6 months
  2. Lactose intolerant, lactose allergy or salicylate allergy
  3. Patients who have already undergone excisional biopsy for qualifying DCIS
  4. Patients with ipsilateral treatment for DCIS or breast cancer within 12 months prior to entering this study
  5. Patients receiving any other chemotherapy or investigational agents
  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.
  7. Liver function tests ≥ 20% of the institutional upper limits of normal
  8. Creatinine \> 1.5 times the institutional upper limit of normal
  9. ANC \< 1,500 /µL
  10. Platelets \< 100,000 /µL
  11. History of allergic reactions attributed to compounds of similar chemical or biologic composition to black cohosh
  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.
  13. Prior/concurrent therapy including:

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

Primary outcomes:
measure: Measure change in size of DCIS on routine imaging
timeFrame: 4 weeks
Secondary outcomes:
measure: Assess adherence to a brief course of black cohosh.
timeFrame: 4 weeks
measure: Assess safety and side effects of 4 week course of black cohosh
timeFrame: 4 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Erin Hofstatter, MD
state: Connecticut
Study officials:
affiliation: Yale University
name: Erin Hofstatter, MD
role: PRINCIPAL_INVESTIGATOR
References: