Breast CancerEarly Phase 1NCT02352025
S-equol in Women With Triple Negative Breast Cancer
A Early Phase 1 study testing S-equol in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- S-equol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Apr 2015to 30 Jun 2020
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
CTRC (Cancer Therapy and Research Center) at UTHSCSA
San Antonio, Texas, 78229
About this study
Official title: 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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- S-equol
- Keywords
- S-equol, breast cancer, triple negative
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
S-equolDrug
Also called Equol
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.
| Study group | Role | What they receive |
|---|---|---|
| S-equol | Experimental | 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. Receives: Drug: S-equol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proliferation Rate of Triple Negative Breast Cancer
Biopsy will measured by change in Ki-67
Measured: 14 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2015 (estimated)
- Study start15 Apr 2015
- Primary completion10 Apr 2019
- Study completion30 Jun 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by The University of Texas Health Science Center at San AntonioThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 39 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kate Lathrop, MD, Principal investigator, principle investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02352025
- Sponsor's protocol ID
- CTMS 14-2018
- Other IDs
- HSC20150231H
- Status last verified
- Jul 2020
- First submitted
- 27 Jan 2015
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pre-surgical Clinical Trial of Therapy With S-equol in Women With Triple Negative Breast Cancer.
- ClinicalTrials.gov ID
- NCT02352025
- Acronym / sponsor ID
- CTMS 14-2018
- Conditions
- Breast Cancer
- Keywords
- S-equol, breast cancer, triple negative
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- The University of Texas Health Science Center at San AntonioUniversity, hospital or other
- Study start
- 15 Apr 2015 (actual)
- Primary completion
- 10 Apr 2019 (actual)
- Study completion
- 30 Jun 2020 (actual)
- First posted
- 30 Jan 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| S-equol | Experimental | Drug: S-equolAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| S-equolAlso: EquolS-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. | Drug | S-equol |
Primary outcome
Proliferation Rate of Triple Negative Breast Cancer
Time frame: 14 Days
Biopsy will measured by change in Ki-67
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kate Lathrop, MD principal investigator
principle investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing S-equol in people with Breast Cancer, run by The University of Texas Health Science Center at San Antonio at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 15 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proliferation Rate of Triple Negative Breast Cancer (time frame: 14 Days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020; AzTrials last refreshed its copy on 8 Nov 2026.