A Pilot Pre-operative Window Trial of Black Cohosh in Women With Ductal Carcinoma in Situ

Not Applicable

Completed

• Conditions: Ductal Carcinoma in Situ
• Interventions: Dietary Supplement: Black cohosh

• Registration Number: NCT01628536
• Lead Sponsor: Yale University

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.

Study Timeline

• Study Start: 2012-06
• Study First Submitted: 2012-06-20
• Study First Submitted QC: 2012-06-25
• Study First Posted: 2012-06-26
• Primary Completion: 2016-01-14
• Study Completion: 2016-06
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-10
• Last Update Posted: 2023-10-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 33

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Black cohosh	Black cohosh	-

Primary Outcome Measures

Name	Time	Method
Measure change in size of DCIS on routine imaging	4 weeks	1. 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; 2. 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.

Secondary Outcome Measures

Name	Time	Method
Assess adherence to a brief course of black cohosh.	4 weeks	To test this secondary hypothesis, we will: Assess adherence to a brief course of black cohosh. Participants will be given an adequate supply of medication for 4 weeks +/- 1 week at the screening/enrollment visit. They will be instructed to bring their medication back on the day of surgery. Pill counts will be conducted by the research nurse to assess the participant's level of compliance.
Assess safety and side effects of 4 week course of black cohosh	4 weeks	To assess this secondary outcome measure we will: Assess safety and side effects through patient history, pill diary and safety labs.

Trial Locations

Locations (1)

Erin Hofstatter, MD; 🇺🇸 New Haven, Connecticut, United States