Using low-dose aspirin to prevent postpartum breast cancer

Targeted Prevention of Postpartum-Related Breast Cancer

This study is testing if taking low-dose aspirin can help lower the risk of breast cancer in new mothers who are about to have a breast biopsy.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Ages: 18 Years to 45 Years
• Sex: Female
• Sponsor: Mayo Clinic (Academic / other)
• Locations: 5 sites (Scottsdale, Arizona and 4 other locations)
• Trial ID: NCT05557877 on ClinicalTrials.gov

What this trial studies

This phase II trial investigates the effects of low-dose aspirin on inflammation markers in postpartum women who are planning to undergo a breast biopsy. The study aims to determine if aspirin can reduce the risk of postpartum-related breast cancer by evaluating changes in specific cancer-related scores and inflammatory markers before and after treatment. Participants will receive daily low-dose aspirin and undergo blood and tissue collection for analysis. If cancer is detected during the biopsy, participants will be removed from the study and provided with treatment options.

Who should consider this trial

Good fit: Ideal candidates are postpartum women aged 18 to 45 who have had a live birth within the last 10 years and are pre-menopausal.

Not a fit: Patients who are older than 45 or who have a history of breast cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could reduce the incidence of postpartum-related breast cancer in women.

How similar studies have performed: While the use of low-dose aspirin for cancer prevention is being explored, this specific approach targeting postpartum-related breast cancer is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* PRE-REGISTRATION: Age \>= 18 years and =\< 45 years of age
* PRE-REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research at two timepoints.
* PRE-REGISTRATION: Had a live birth =\< 10 years prior to pre-registration
* PRE-REGISTRATION: Pre-menopausal according to patient report and/or clinical determination
* PRE-REGISTRATION: Provide written informed consent
* PRE-REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance
* PRE-REGISTRATION: Willingness to provide mandatory blood and urine specimens for correlative research
* REGISTRATION: Age \>= 18 years and =\< 45 years of age
* 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)
* REGISTRATION: Hemoglobin \>= 9.0 g/dL (obtained =\< 90 days prior to registration)
* REGISTRATION: Platelet count \>= 100,000/mm\^3 (obtained =\< 90 days prior to registration
* REGISTRATION: Serum creatinine =\< 2.0 mg/dl (obtained =\< 90 days prior to registration)
* REGISTRATION: Negative pregnancy test done =\< 15 days prior to registration
* REGISTRATION: Willing to use contraception while on treatment
* REGISTRATION: Provide written informed consent
* REGISTRATION: Ability to complete questionnaire(s) by themselves or with assistance
* REGISTRATION: Willingness to provide mandatory blood and urine specimens for correlative research
* REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research
* REGISTRATION: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Exclusion Criteria:

* PRE-REGISTRATION: History of breast cancer including ductal breast carcinoma in situ (DCIS)
* PRE-REGISTRATION: Received systemic treatment for any other cancer at any time
* 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)
* PRE-REGISTRATION: Currently taking other agents for the prevention of breast cancer
* PRE-REGISTRATION: Currently taking anticoagulants
* PRE-REGISTRATION: Contraindication for aspirin use
* PRE-REGISTRATION: Known or suspected active breast infection
* REGISTRATION: Known DCIS or invasive cancer
* REGISTRATION: No research tissue available from pre-registration biopsy or from archived tissue (collected =\< 12 months prior to pre-registration)
* 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)
* 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
* REGISTRATION: Any contraindication to aspirin use including but not limited to:

  * Bleeding disorders (e.g., hemophilia)
  * Stomach or intestinal bleeding =\< 6 months prior to registration
  * Known allergy to other non-steroidal anti-inflammatory drugs (NSAIDs)
* REGISTRATION: Currently taking anticoagulants
* REGISTRATION: Any prior or current malignancy requiring prior or current systemic therapy
* REGISTRATION: Currently pregnant or planning to become pregnant in the next 90 days
* REGISTRATION: Post-menopausal:

  * Prior bilateral surgical oophorectomy or
  * No menses for \> 1 year with estradiol levels within postmenopausal range, according to institutional standard
* REGISTRATION: Known or suspected active breast infection

Where this trial is running

Scottsdale, Arizona and 4 other locations

• Mayo Clinic in Arizona — Scottsdale, Arizona, United States (Terminated)
• Mayo Clinic in Florida — Jacksonville, Florida, United States (Recruiting)
• Indiana University Simon Comprehensive Cancer Center — Indianapolis, Indiana, United States (Recruiting)
• Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
• University of North Carolina — Chapel Hill, North Carolina, United States (Recruiting)

Study contacts

• Principal investigator: Kathryn J. Ruddy, MD — Mayo Clinic in Rochester
• Study coordinator: Clinical Trials Referral Office

Conditions Breast Carcinoma