Back to resultsS-equol in Women With Triple Negative Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
S-equol
Sponsored by
About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring S-equol, breast cancer, triple negative
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
Sites / Locations
- CTRC (Cancer Therapy and Research Center) at UTHSCSA
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
S-equol
Arm Description
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.
Outcomes
Primary Outcome Measures
Proliferation Rate of Triple Negative Breast Cancer
Biopsy will measured by change in Ki-67
Secondary Outcome Measures
Full Information
NCT ID
NCT02352025
First Posted
January 27, 2015
Last Updated
July 21, 2020
Sponsor
The University of Texas Health Science Center at San Antonio
1. Study Identification
Unique Protocol Identification Number
NCT02352025
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.
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
April 15, 2015 (Actual)
Primary Completion Date
April 10, 2019 (Actual)
Study Completion Date
June 30, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
S-equol, breast cancer, triple negative
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
39 (Actual)
8. Arms, Groups, and Interventions
Arm Title
S-equol
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
S-equol
Other Intervention Name(s)
Equol
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proliferation Rate of Triple Negative Breast Cancer
Description
Biopsy will measured by change in Ki-67
Time Frame
14 Days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kate Lathrop, MD
Organizational Affiliation
principle investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
CTRC (Cancer Therapy and Research Center) at UTHSCSA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
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S-equol in Women With Triple Negative Breast Cancer
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