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

October 10, 2023 updated by: Yale University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

33

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Erin Hofstatter, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Black cohosh
Dietary supplement: Black cohosh
Remifemin 20 mg tablet orally twice per day x 4 weeks
Other Names:
  • Remifemin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Measure change in size of DCIS on routine imaging
Time Frame: 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.
4 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assess adherence to a brief course of black cohosh.
Time Frame: 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.
4 weeks
Assess safety and side effects of 4 week course of black cohosh
Time Frame: 4 weeks

To assess this secondary outcome measure we will:

Assess safety and side effects through patient history, pill diary and safety labs.
4 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yale University

Investigators

  • Principal Investigator: Erin Hofstatter, MD, Yale University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

January 14, 2016

Study Completion (Actual)

June 1, 2016

Study Registration Dates

First Submitted

June 20, 2012

First Submitted That Met QC Criteria

June 25, 2012

First Posted (Estimated)

June 26, 2012

Study Record Updates

Last Update Posted (Actual)

October 13, 2023

Last Update Submitted That Met QC Criteria

October 10, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1205010204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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