- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02352025
S-equol in Women With Triple Negative Breast Cancer
July 21, 2020 updated by: The University of Texas Health Science Center at San Antonio
A Pre-surgical Clinical Trial of Therapy With S-equol in Women With Triple Negative Breast Cancer.
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.
Study Overview
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.
Study Type
Interventional
Enrollment (Actual)
39
Phase
- Early Phase 1
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
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Texas
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San Antonio, Texas, United States, 78229
- CTRC (Cancer Therapy and Research Center) at UTHSCSA
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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
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
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 |
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Experimental: S-equol
After 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.
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S-equol should be administered orally, twice daily (12 hours apart), preferably on an empty stomach with a glass of water.
Tablets should be swallowed whole.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proliferation Rate of Triple Negative Breast Cancer
Time Frame: 14 Days
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Biopsy will measured by change in Ki-67
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14 Days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Kate Lathrop, MD, principle investigator
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 (Actual)
April 15, 2015
Primary Completion (Actual)
April 10, 2019
Study Completion (Actual)
June 30, 2020
Study Registration Dates
First Submitted
January 27, 2015
First Submitted That Met QC Criteria
January 27, 2015
First Posted (Estimate)
January 30, 2015
Study Record Updates
Last Update Posted (Actual)
July 22, 2020
Last Update Submitted That Met QC Criteria
July 21, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTMS 14-2018
- HSC20150231H (Other Identifier: University of Texas Health Science Center- San Antonio)
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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