Recruiting
Phase 2

Fisetin

Sponsor:

Jonsson Comprehensive Cancer Center

Code:

NCT05595499

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Biospecimen Collection

Fisetin

Placebo Administration

Quality-of-Life Assessment

Questionnaire Administration

Study Details

Brief summary:

This phase II trial tests whether fisetin works to improve physical function in women who have received chemotherapy for stage I-III breast cancer treatment. Fisetin is a naturally occurring substance that is found in strawberries and other foods. Fisetin eliminates cells that have undergone a process called senescence. Senescence is when a cell ages and permanently stops dividing but does not die. Over time, large numbers of these cells build up in tissues throughout the body and can release harmful substances that causes inflammation and damages nearby healthy cells. Studies have shown that chemotherapy causes a build-up of these senescent cells. Giving fisetin may eliminate senescent cells and improve physical function in postmenopausal women who have received chemotherapy for breast cancer.

Conditions

Anatomic Stage I Breast Cancer AJCC v8

Anatomic Stage II Breast Cancer AJCC v8

Anatomic Stage III Breast Cancer AJCC v8

Study ID

NCT05595499

Start date

Mar 27, 2023

Status verified date

Jul, 2026

Completion date

Aug 14, 2028

Anticipated

Primary completion date

Aug 14, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Women who are postmenopausal at the start of study treatment.

Postmenopausal status will be established as follows:

  • Women aged: >= 60 years OR
  • Women aged < 60 years AND one of the following conditions is met:

  • They have not had any menstrual periods for at least 12 months in the absence of exogenous hormonal treatments, chemotherapy, and/or tamoxifen AND have serum estradiol and follicle-stimulating hormone (FSH) levels confirmed as being within the standard laboratory reference range for postmenopausal females.
  • They have documented irreversible bilateral oophorectomy.
  • They are receiving ovarian suppression with their breast cancer endocrine therapy

  • Women with a diagnosis of early-stage breast cancer (Stage I-III) treated with neo/adjuvant chemotherapy within 12 months of starting study treatment
  • No evidence of active/recurrent breast cancer or other serious chronic illnesses
  • Have evidence of frail health, defined as a diminished 6-minute walk distance (< 400m) at baseline
  • Platelets > 60,000/mm\^3
  • White blood cell count > 2,000/mm\^3
  • Absolute neutrophil count > 500/mm\^3
  • Hemoglobin >= 8.0 g/dL
  • Total bilirubin =< 3.0 X upper limit of normal (ULN)
  • Aspartate aminotransferase (AST) =< 4.0 x ULN
  • Alanine aminotransferase (ALT) =< 4.0 x ULN
  • Estimated glomerular filtration rate (eGFR) of >= 30mL/min/1.73m\^2 per the Modification of Diet in Renal Disease (MDRD) calculation
  • Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

  • Cancer-directed chemotherapy, biological therapy, or immunotherapy within 30 days prior to the start of study treatment. Exceptions include: trastuzumab, pertuzumab, pembrolizumab, tamoxifen, ribociclib, abemaciclib, aromatase inhibitors and/or ovarian suppression.
  • Surgery and/or radiation within the last 30 days of starting study treatment (Exception: invasive non- major procedures such as an outpatient biopsy)
  • Subjects taking medications that are considered prohibited.

  • Exception: Subjects taking any of the medications listed in under "Temporary medication adjustment required" may participate if they are otherwise eligible AND the medication can be safely withheld (from immediately before the 1st study agent administration until at least 10 hours after the last study agent administration, for each dosing interval)
  • On herbal and natural medications with possible senolytic properties (i.e., curcumin, kava kava, St. John's wort) and are unable or unwilling to hold its administration 2 days prior to and during study treatment dosing. Exceptions include cannabidiol (CBD), vitamins, probiotics, and fish oil. Other herbal and natural medications may be permitted or prohibited per clinician discretion
  • Subjects taking potentially senolytic agents within the last year: fisetin, quercetin, luteolin, dasatinib or imatinib (or other tyrosine kinase inhibitors), piperlongumine, or navitoclax
  • Subjects on therapeutic doses of anticoagulants (e.g., warfarin, heparin, low molecular weight heparin, factor Xa inhibitors, etc.)
  • Issues with tolerating oral medication (such as but not limited to, inability to swallow pills (g-tubes not allowed), malabsorption issues, ongoing nausea or vomiting during screening, history of Crohn's, gastric bypass/reduction, or celiac disease)
  • Any other condition that would, in the Investigator's judgment, contraindicate the patient's participation in the clinical study due to safety concerns with clinical study procedures
  • Currently participating in another intervention research study seeking to improve functional status, alleviate frailty, muscle strength, exhaustion/fatigue, or cognitive function

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A (fisetin)

Patients receive fisetin PO on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial.

placebo comparator: Arm B (placebo)

Patients receive placebo PO on the trial. on days 1, 2, and 3. Treatment repeats every 2 weeks for up to 8 weeks in the absence of disease progression or unacceptable toxicity. Patients also undergo collection of blood samples throughout the trial.

Interventions

Biospecimen Collection

Undergo collection of blood samples

Fisetin

Given PO

Placebo Administration

Given PO

Quality-of-Life Assessment

Ancillary studies

Questionnaire Administration

Ancillary studies

Primary outcome measure

  • Change in 6-minute walk distance (6MWD) [ Time Frame: Baseline to day 60 ]

Central Contacts and Locations

Central contacts

Mina S. Sedrak, MD

310-825-3181msedrak@mednet.ucla.edu

Kelly Synold

424-440-3877ksynold@mednet.ucla.edu

Locations

UCLA Health Cancer Care in Alhambra

Recruiting

Alhambra, California, United States, 91801

Contacts

Mina S. Sedrak, MD

310-825-3181msedrak@mednet.ucla.edu

UCLA Health Beverly Hills Primary & Specialty Care

Recruiting

Beverly Hills, California, United States, 90210

Contacts

Mina S. Sedrak, MD

310-825-3181msedrak@mednet.ucla.edu

UCLA Health Burbank Primary & Specialty Care

Recruiting

Burbank, California, United States, 91505

Contacts

Mina S. Sedrak, MD

310-825-3181msedrak@mednet.ucla.edu

City of Hope Comprehensive Cancer Center

Recruiting

Duarte, California, United States, 91010

Contacts

Keilani Luna

909-809-9338kluna@coh.org

Marie D. Yee, MD

626-256-4673lyee@coh.org

Principal Investigator:

Lisa D. Yee, MD

UCLA / Jonsson Comprehensive Cancer Center

Recruiting

Los Angeles, California, United States, 90095

Contacts

Mina S. Sedrak

310-825-3181msedrak@mednet.ucla.edu

Principal Investigator:

Mina S. Sedrak

UCLA Health Primary Care in Marina del Rey

Recruiting

Marina del Rey, California, United States, 90292

Contacts

Mina S. Sedrak, MD

310-825-3181msedrak@mednet.ucla.edu

UCLA Health Primary Care in Pasadena

Recruiting

Pasadena, California, United States, 91105

Contacts

Mina S. Sedrak, MD

310-825-3181msedrak@mednet.ucla.edu

More Information

Sponsor

Jonsson Comprehensive Cancer Center

Last update posted

Jul 17, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Jonsson Comprehensive Cancer Center on 2026-07-17.