RECRUITING

Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

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Conditions

Breast Carcinoma

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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 tests whether low-dose aspirin can affect markers of inflammation in postpartum (after childbirth) women planning to have a breast biopsy. Chronic inflammation may increase the risk of postpartum related breast cancer. Low-dose aspirin is a non-steroidal anti-inflammatory drug. Giving low-dose aspirin may affect markers of inflammation in blood and tissue and may prevent postpartum related breast cancer.

Official Title

Targeted Prevention of Postpartum-Related Breast Cancer

Quick Facts

Study Start:2023-03-09
Study Completion:2027-01-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05557877

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:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * PRE-REGISTRATION: Age \>= 18 years and =\< 45 years of age
  2. * PRE-REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research at two timepoints.
  3. * PRE-REGISTRATION: Had a live birth =\< 10 years prior to pre-registration
  4. * PRE-REGISTRATION: Pre-menopausal according to patient report and/or clinical determination
  5. * PRE-REGISTRATION: Provide written informed consent
  6. * PRE-REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance
  7. * PRE-REGISTRATION: Willingness to provide mandatory blood and urine specimens for correlative research
  8. * REGISTRATION: Age \>= 18 years and =\< 45 years of age
  9. * REGISTRATION: Registration for this study must be completed either =\< one (1) year after the qualifying pre-registration biopsy is performed for this study or =\< one (1) year after collection of the archived tissue (for those who did not have a pre-registration biopsy performed after pre-registration for this study)
  10. * REGISTRATION: Hemoglobin \>= 9.0 g/dL (obtained =\< 30 days prior to registration)
  11. * REGISTRATION: Platelet count \>= 100,000/mm\^3 (obtained =\< 30 days prior to registration
  12. * REGISTRATION: Serum creatinine =\< 2.0 mg/dl (obtained =\< days prior to registration)
  13. * REGISTRATION: Negative pregnancy test done =\< 14 days prior to registration
  14. * REGISTRATION: Willing to use contraception while on treatment
  15. * REGISTRATION: Provide written informed consent
  16. * REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance
  17. * REGISTRATION: Willingness to provide mandatory blood and urine specimens for correlative research
  18. * REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)
  1. * PRE-REGISTRATION: History of breast cancer including ductal breast carcinoma in situ (DCIS)
  2. * PRE-REGISTRATION: Received systemic treatment for any other cancer at any time
  3. * PRE-REGISTRATION: Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDS) (no doses within =\< 5 days prior to pre-registration and no more than four doses within =\< 30 days prior to pre-registration)
  4. * PRE-REGISTRATION: Currently taking other agents for the prevention of breast cancer
  5. * PRE-REGISTRATION: Currently taking anticoagulants
  6. * PRE-REGISTRATION: Contraindication for aspirin use
  7. * PRE-REGISTRATION: Known or suspected active breast infection
  8. * REGISTRATION: Known DCIS or invasive cancer
  9. * REGISTRATION: No research tissue available from pre-registration biopsy or from archived tissue (collected =\< 12 months prior to pre-registration)
  10. * REGISTRATION: Currently taking aspirin or other non-steroidal anti-inflammatory drugs (NSAIDs) (NOTE: no doses within =\< 5 days prior to registration and no more than four doses within =\< 30 days prior to registration)
  11. * REGISTRATION: Co-morbid illnesses/conditions which, in the judgment of the investigator, would make the patient inappropriate for entry into this study or interfere significantly with the proper assessment of safety and toxicity of the prescribed regimens
  12. * REGISTRATION: Any contraindication to aspirin use including but not limited to:
  13. * Bleeding disorders (e.g., hemophilia)
  14. * Stomach or intestinal bleeding =\< 6 months prior to registration
  15. * Known allergy to other non-steroidal anti-inflammatory drugs (NSAIDs)
  16. * REGISTRATION: Currently taking anticoagulants
  17. * REGISTRATION: Any prior or current malignancy requiring prior or current systemic therapy
  18. * REGISTRATION: Currently pregnant or planning to become pregnant in the next 90 days
  19. * REGISTRATION: Post-menopausal:
  20. * Prior bilateral surgical oophorectomy or
  21. * No menses for \> 1 year with estradiol levels within postmenopausal range, according to institutional standard
  22. * REGISTRATION: Known or suspected active breast infection

Contacts and Locations

Study Contact

Clinical Trials Referral Office
CONTACT
855-776-0015
mayocliniccancerstudies@mayo.edu

Principal Investigator

Kathryn J. Ruddy, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic in Rochester

Study Locations (Sites)

Mayo Clinic in Arizona
Scottsdale, Arizona, 85259
United States
Mayo Clinic in Florida
Jacksonville, Florida, 32224-9980
United States
Indiana University Simon Comprehensive Cancer Center
Indianapolis, Indiana, 46202
United States
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
United States

Collaborators and Investigators

Sponsor: Mayo Clinic

  • Kathryn J. Ruddy, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic in Rochester

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 Date2023-03-09
Study Completion Date2027-01-30

Study Record Updates

Study Start Date2023-03-09
Study Completion Date2027-01-30

Terms related to this study

Additional Relevant MeSH Terms

  • Breast Carcinoma