S-equol in Women With Triple Negative Breast Cancer

• ClinicalTrials.gov Identifier: NCT02352025
• Recruitment Status: Completed
• First Posted: January 30, 2015
• Last Update Posted: July 22, 2020
• Sponsor: The University of Texas Health Science Center at San Antonio
• Information provided by (Responsible Party): The University of Texas Health Science Center at San Antonio

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer	Drug: S-equol	Early Phase 1

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Pre-surgical Clinical Trial of Therapy With S-equol in Women With Triple Negative Breast Cancer.
• Actual Study Start Date: April 15, 2015
• Actual Primary Completion Date: April 10, 2019
• Actual Study Completion Date: June 30, 2020

Arms and Interventions

Arm	Intervention/treatment
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.	Drug: S-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.; Other Name: Equol

Outcome Measures

Primary Outcome Measures :

1. Proliferation Rate of Triple Negative Breast Cancer [ Time Frame: 14 Days ]
   Biopsy will measured by change in Ki-67

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Texas

CTRC (Cancer Therapy and Research Center) at UTHSCSA

San Antonio, Texas, United States, 78229

Sponsors and Collaborators

The University of Texas Health Science Center at San Antonio

Investigators

• Principal Investigator: Kate Lathrop, MD; principle investigator

More Information

• Responsible Party: The University of Texas Health Science Center at San Antonio
• ClinicalTrials.gov Identifier: NCT02352025
• Other Study ID Numbers: CTMS 14-2018; HSC20150231H ( Other Identifier: University of Texas Health Science Center- San Antonio )
• First Posted: January 30, 2015
• Last Update Posted: July 22, 2020
• Last Verified: July 2020

Keywords provided by The University of Texas Health Science Center at San Antonio:

S-equol; breast cancer; triple negative

Additional relevant MeSH terms:

Equol; Breast Neoplasms; Triple Negative Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Phytoestrogens; Estrogens, Non-Steroidal; Estrogens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs