RECRUITING

Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction

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Conditions

Breast Atypical HyperplasiaBreast CarcinomaBreast Ductal Carcinoma In SituBreast Lobular Carcinoma In Situ

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This phase II trial evaluates tamoxifen, with or without omega-3 fatty acids, for reducing risk of breast cancer among postmenopausal and overweight or obese women who are at increased risk of developing breast cancer. Tamoxifen is a selective estrogen receptor modulator. It works by blocking the effects of the hormone estrogen in the breast. Tamoxifen is approved by the Food and Drug Administration for prevention of breast cancer in women at increased risk. Omega-3 fatty acids have been shown to decrease the amount of fats made in the liver. Omega-3 fatty acids may work to prevent cancer in overweight or obese individuals. Tamoxifen with or without omega-3 fatty acids may be effective at reducing risk of breast cancer among women who are postmenopausal, overweight or obese, and at increased risk.

Official Title

Phase 2 Study of Low Dose Tamoxifen +/- High Dose Omega-3 Fatty Acids in Overweight Postmenopausal Women at Increased Risk for Breast Cancer

Quick Facts

Study Start:2025-04-01
Study Completion:2028-01-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06195306

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:45 Years to 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age 45 - 65
  2. * Postmenopausal female
  3. * Postmenopausal is defined as prior removal of the ovaries, or if ovaries intact amenorrhea for 12 months and not on any form of contraception, or amenorrhea for greater than 2 months with serum follicle-stimulating hormone (FSH) in postmenopausal range (\>= 25 IU/L). Women with ovaries and a prior hysterectomy or endometrial ablation \< age 55 must have a FSH within the postmenopausal range. Women may be on vaginal low dose estrogen preparations for vaginal dryness. Women over age 50 with a levonorgestrel intrauterine device in place for 2 or more years are also eligible if FSH is in the postmenopausal range and they are not planning removal for the next 6 months
  4. * Note: FSH will be done at time of screening
  5. * Women with intact ovaries and uterus \< age 55 must have a negative pregnancy test prior to randomization
  6. * Obese (body mass index \[BMI\] \>= 30 kg/m\^2) OR overweight (BMI 25 to \< 30 kg/m\^2) WITH at least two or more of the following elements of metabolic syndrome documented in the past 180 days prior to randomization:
  7. * Waist circumference of \>= 89 cm
  8. * Blood pressure over 130/85 mmHg (or current treatment for hypertension)
  9. * Fasting triglyceride (TG) level over 150 mg/dl
  10. * Fasting high-density lipoprotein (HDL) \< 50 mg/dl (or current statin treatment)
  11. * Fasting glucose \> 100 mg/dl
  12. * Note: BMI must be calculated within 28 days of randomization
  13. * Willing to undergo a fasting blood draw and non-fasting RPFNA with fixed and frozen aliquots sent to University of Kansas Medical Center (KUMC)
  14. * At increased risk of breast cancer per at least one of the following:
  15. * Personal medical history
  16. * History of atypical hyperplasia or lobular carcinoma in situ (LCIS) found on breast biopsy
  17. * History of unilateral ductal carcinoma in situ treated with unilateral mastectomy, lumpectomy, or local excision with or without radiation and this treatment was completed at least 3 months prior to the screening RPFNA
  18. * High mammographic density determined by one of the following:
  19. * Visual estimate of area of density (VAS) \> 50%,
  20. * Volpara (trademark) \>= 15% dense volume (Volpara d)
  21. * Breast Imaging Reporting and Data System (BIRADS) assessment = extremely dense (BIRADs D)
  22. * Genetic test result
  23. * Germline gene mutation in ATM, BARD1, CDH1, CHEK2, NF1, PTEN, RAD51C, RAD51D, or STK11
  24. * Polygenic lifetime risk score \>= 2x average or 25%
  25. * Calculated risk based on standard models
  26. * Five-year Breast Cancer Risk Assessment Tool (BCRAT) (version 2.0) \>= 1.66% (https://dceg.cancer.gov/tools/risk-assessment/bcra)
  27. * Ten-year International Breast Cancer Intervention Study risk evaluation tool (IBIS) (version 8) \>= 3% (http://www.ems-trials.org/riskevaluator/)
  28. * Ten-year relative risk IBIS (version 8) \>= 2X that for age group
  29. * Ten- year Breast Cancer Surveillance Consortium (version 2) \>= 3% (https://tools.bcscscc.org/BC5yearRisk/calculator.htm)
  30. * Family History
  31. * Breast cancer in a first or second degree relative (female or male) with onset under age 50. (First degree relative = parent, sibling, or child. Second degree relative = grandparent, uncle, aunt, nephew, niece, half-sibling, grandchild or first cousin)
  32. * Breast cancer in two or more first or second-degree relatives from either the maternal or paternal linage without regard to age
  33. * Bilateral breast cancer or breast and ovarian cancer in the same first or second degree relative without regard to age
  34. * Primary source documentation of risk is required and must be submitted to the lead academic organization (LAO) for review along with the eligibility checklist
  35. * Risk factor: Atypical hyperplasia or LCIS; Primary source document: Copy of pathology report or clinical note confirming the diagnosis
  36. * Risk factor: Ductal carcinoma in situ (DCIS) and treatment history; Primary source document: Copies of pathology report or clinic notes confirming the diagnosis, treatment plan and treatment end date(s)
  37. * Risk factor: Mammographic density; Primary source document: Copy of clinic note or mammogram report
  38. * Risk factor: Genetic; Primary source document: Copy of genetic test report
  39. * Risk factor: Calculated based on standard models; Primary source document: Copy of the calculation result
  40. * Total bilirubin =\< 1.5 x institutional upper limit of normal (ULN)
  41. * Note: Higher total bilirubin levels (=\< 3 mg/dL) can be allowed if due to known benign liver condition, i.e., Gilbert's syndrome
  42. * Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \[SGOT\]) =\< 3.0 x institutional upper limit of normal
  43. * Alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 3.0 x institutional upper limit of normal
  44. * Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial
  45. * For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated
  46. * Patients with a history of hepatitis C virus (HCV) infection must have been treated and cured. For patients with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load
  47. * Patients on chronic suppressive antiviral therapy for herpes simplex virus (HSV) are eligible
  48. * Eastern Cooperative Oncology Group (ECOG) performance status =\< 2 (Karnofsky \>= 60%)
  49. * Women must have at least 1 unaffected untreated breast for fine needle aspiration. Women may have had prior unilateral breast radiation or mastectomy for DCIS
  50. * Ability to understand and the willingness to sign a written informed consent document
  1. * Exclusions based on current or past conditions:
  2. * Bilateral breast implants (danger of implant puncture with RPFNA)
  3. * Prior invasive breast cancer
  4. * Prior invasive uterine cancer
  5. * Other prior invasive cancer and haven't completed cancer related therapy or with evidence of disease (other than non-melanoma skin cancer) within the past 2 years
  6. * Currently breastfeeding (concern that tamoxifen may be in breast milk) or nursing within past 12 months (concern about milk fistula with RPFNA)
  7. * Type I or type II diabetes mellitus requiring current pharmacologic treatment (including metformin, glucagon-like peptide 1 agonists, insulin, sulfonylurea)
  8. * Prior deep vein thrombosis, pulmonary embolus, or stroke
  9. * Prior gastric bypass surgery
  10. * History of chronic liver disease including NASH (nonalcoholic steatohepatitis) or cirrhosis
  11. * Planned initiation of a structured weight loss intervention
  12. * Current use of or plans to initiate a glucagon-like peptide 1 agonist within the next 6 months
  13. * Exclusions based on medications:
  14. * Current use of prescription anticoagulants such as Coumadin (warfarin), direct-acting oral anticoagulants such as Xarelto (rivaroxaban) or Eliquis (apixaban) or heparin
  15. * Women who would not be able to or do not wish to discontinue daily use of aspirin (81mg or higher) and aspirin containing products (81 mg or higher) at least 3 weeks prior to each RPFNA
  16. * Note: Women may resume daily use of aspirin and aspirin containing products 3 days after each RPFNA procedure
  17. * Planned removal of hormone intrauterine device within the next 6 months
  18. * Current use of hormone therapy (oral, transdermal, or injectable)
  19. * Note: Vaginal estrogen is allowed
  20. * Prior treatment with tamoxifen, aromatase inhibitor or selective estrogen receptor degrader for more than 2 months
  21. * Note: Women with \< 2 months of these drugs must be off for at least 6 months before they may begin biomarker screening tests
  22. * Greater than 1 gram daily of omega-3 fatty acid supplement within the last 6 months
  23. * Current use of prescription immunosuppressive drugs
  24. * Current usage of CYP3A4 strong inducers rifampin or aminoglutethimide
  25. * Participants may not be receiving any other investigational agents
  26. * History of allergic reactions attributed to compounds of similar chemical or biologic composition to tamoxifen or omega-3 fatty acid or generic Lovaza or compounds of similar chemical composition
  27. * Uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements

Contacts and Locations

Principal Investigator

Lauren Nye
PRINCIPAL_INVESTIGATOR
University of Kansas

Study Locations (Sites)

University of Kansas Cancer Center
Kansas City, Kansas, 66160
United States
University of Michigan Comprehensive Cancer Center
Ann Arbor, Michigan, 48109
United States
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
United States

Collaborators and Investigators

Sponsor: National Cancer Institute (NCI)

  • Lauren Nye, PRINCIPAL_INVESTIGATOR, University of Kansas

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-01
Study Completion Date2028-01-01

Study Record Updates

Study Start Date2025-04-01
Study Completion Date2028-01-01

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Atypical Hyperplasia
  • Breast Carcinoma
  • Breast Ductal Carcinoma In Situ
  • Breast Lobular Carcinoma In Situ