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RecruitingPhase 2

Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Targeted Prevention of Postpartum-Related Breast Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 45 Years
Sex
Female only
Healthy volunteers
Accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Biopsies

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "OUTLINE: Patients undergo standard of care breast biopsy for assessment of abnormalities seen on imaging, as well as collection of blood during screening."
  • "Patients may undergo breast biopsy as clinically indicated."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether low-dose aspirin changes signs of inflammation in blood and breast tissue. It is for women ages 18 to 45 who gave birth in the past 10 years, have not gone through menopause, and are planning a breast biopsy or have stored breast tissue. The study explores whether aspirin may help prevent breast cancer after childbirth.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be 18 to 45 years old, have had a live birth in the past 10 years, and not have gone through menopause.
  • Agree in writing to join the study and complete surveys, with help if needed.
  • Agree to give breast tissue samples at two time points, plus blood and urine samples for research.
  • Complete study registration within 1 year after the study biopsy or collection of stored breast tissue.
  • Have blood tests within 90 days before registration: hemoglobin of at least 9.0 g/dL and platelets of at least 100,000/mm³. These measure a protein that carries oxygen and cells that help blood clot.
  • Have a creatinine level of 2.0 mg/dL or less within 90 days before registration. This test checks kidney function.
  • Have a negative pregnancy test within 15 days before registration and agree to use birth control during treatment.
  • Be willing to return to the study center for follow-up visits during active monitoring.

Who can't join

  • Have had breast cancer, including DCIS (cancer cells inside the milk ducts), or have known invasive cancer. Also excluded: any past or current cancer needing treatment that reaches the whole body.
  • Have no breast tissue available for research from the study biopsy or stored tissue collected within 12 months before pre-registration.
  • Take aspirin or other NSAIDs (anti-inflammatory pain medicines): any dose within 5 days, or more than 4 doses within 30 days, before pre-registration or registration.
  • Currently take blood thinners or medicines to prevent breast cancer.
  • Cannot safely take aspirin, including because of a bleeding disorder, stomach or bowel bleeding within 6 months before registration, or an allergy to other NSAIDs.
  • Have a known or suspected breast infection, or another illness that the study doctor thinks makes joining unsafe or makes safety checks difficult.
  • Are pregnant or plan to become pregnant in the next 90 days.
  • Have gone through menopause: both ovaries were removed, or periods stopped for more than 1 year and hormone tests show menopause.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (5)

AZ

FL

IN

MN

NC