S-equol in Women With Triple Negative Breast Cancer

NCT02352025 | Completed Early Phase 1 DMC

• 2 other identifiers: CTMS 14-2018HSC20150231H
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

S-equol; breast cancer; triple negative

Outcome Measures

Primary Outcomes (1)

• Proliferation Rate of Triple Negative Breast Cancer

  Biopsy will measured by change in Ki-67

  14 Days

Study Arms (1)

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.

Drug: S-equol

Interventions

S-equol DRUG

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.

Also known as: Equol

S-equol

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• The University of Texas Health Science Center at San Antonio: lead

Study Sites (1)

CTRC (Cancer Therapy and Research Center) at UTHSCSA

San Antonio, Texas, 78229, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Equol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Isoflavones; Flavonoids; Chromones; Benzopyrans; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Kate Lathrop, MD

  principle investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2015
• First Posted: January 30, 2015
• Study Start: April 15, 2015
• Primary Completion: April 10, 2019
• Study Completion: June 30, 2020
• Last Updated: July 22, 2020

Record last verified: 2020-07

Locations

US (1)