Clinical Trials /

S-equol in Women With Triple Negative Breast Cancer

NCT02352025

Description:

The primary objective of this study is to determine if S-equol, an ER-beta agonist, is effective in decreasing the proliferation rate of triple negative breast cancer.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Early Phase 1

Trial Eligibility

Document

Title

  • Brief Title: S-equol in Women With Triple Negative Breast Cancer
  • Official Title: A Pre-surgical Clinical Trial of Therapy With S-equol in Women With Triple Negative Breast Cancer.

Clinical Trial IDs

  • ORG STUDY ID: CTMS 14-2018
  • SECONDARY ID: HSC20150231H
  • NCT ID: NCT02352025

Conditions

  • Breast Cancer

Interventions

DrugSynonymsArms
S-equolEquolS-equol

Purpose

The primary objective of this study is to determine if S-equol, an ER-beta agonist, is effective in decreasing the proliferation rate of triple negative breast cancer.

Detailed Description

      After a baseline breast tumor core biopsy, eligible women with triple negative breast cancer
      (ER- alpha, PR and HER-2 receptor negative) will be treated with S-equol at a dose of 50 mg
      twice daily for a period of about 14 days (10-21 day range). After completion of treatment, a
      second breast tumor sample will be obtained to compare molecular changes between the two
      specimens. The second pathology specimen may be from the surgical resection of the breast
      tumor, or a repeat core needle biopsy, if no further surgery is planned. The primary endpoint
      will be the absolute change in the Ki67, which is a validated marker of tumor proliferation
      in breast cancer. Secondary endpoints will include assessment of total ER-beta and pY36
      levels as measured by immunohistochemical staining and their correlation with S-equol
      effects. Further treatment after surgical resection or second core needle biopsy of the tumor
      will be guided by tumor size, nodal status and other standard parameters, and is at the
      discretion of the treating physician. The Investigator hypothesizes that S-equol will cause a
      measurable decrease in Ki-67 in estrogen receptor beta expressing triple negative breast
      cancers, indicating its potential efficacy in this tumor type.
    

Trial Arms

NameTypeDescriptionInterventions
S-equolExperimentalAfter having a core needle biopsy of the breast confirming triple negative breast cancer, eligible women enrolled on the study will be treated with S-equol at a dose of 50 mg PO twice daily for 14 days.
  • S-equol

Eligibility Criteria

        Inclusion Criteria:

          -  Participants must be women who are 18 years old or older.

          -  Ability to consent to treatment - patients or their legally authorized representative
             must be informed of the investigational nature of this study and must sign and give
             written informed consent in accordance with institutional and federal guidelines.

          -  Previously untreated breast cancer determined by a core needle biopsy showing invasive
             ductal carcinoma or invasive lobular carcinoma.

          -  A prior, unrelated, breast cancer is allowed.

          -  All stages of breast cancer are eligible.

          -  Estrogen receptor negative - defined as less than or equal to 5% staining by IHC.

          -  Progesterone receptor negative - defined as less than or equal to 5% staining by IHC.

          -  HER 2 negative as defined as 2+ or less using IHC or a ratio of less than 2.0 on FISH
             testing.

          -  Patient must be able to take oral medications. Patients may not have any impairment of
             gastrointestinal function or gastrointestinal disease that may significantly alter the
             absorption of the study drug.

          -  Patients may not be pregnant or breast feeding.

          -  Patients must with eligible for surgical resection of their breast cancer or repeat
             biopsy after completing 14 days of treatment.

          -  Patients must have a complete history and physical examination within 28 days prior to
             registration.

          -  Patients must have a performance status of ECOG 0, 1, 2.

          -  Patient may not be concurrently enrolled in another investigational drug treatment
             study.

          -  Tissue block of initial biopsy specimen is available.

        Exclusion Criteria:

          -  Known hypersensitivity to S-equol or any of its excipients.

          -  ECOG status 3 or 4.

          -  As judged by the investigator, severe uncontrolled concurrent medical conditions,
             psychiatric illness or social condition that would limit compliance with study
             requirements.

          -  Evidence of any significant clinical disorder or laboratory finding that makes it
             undesirable for the subject to participant in the clinical trial.

          -  Any prior treatment for the current, newly diagnosed breast cancer.

          -  Current use of SERMS or aromatase inhibitors.

          -  Inflammatory breast cancer or patients with rapidly progressing metastatic breast
             cancer
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:Proliferation Rate of Triple Negative Breast Cancer
Time Frame:14 Days
Safety Issue:
Description:Biopsy will measured by change in Ki-67

Details

Phase:Early Phase 1
Primary Purpose:Interventional
Overall Status:Recruiting
Lead Sponsor:The University of Texas Health Science Center at San Antonio

Trial Keywords

  • S-equol
  • breast cancer
  • triple negative

Last Updated

September 15, 2017