Health Trials

Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

ConditionBreast Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-45
SponsorMayo Clinic

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Biospecimen Collection
  • Low-Dose Aspirin
  • Questionnaire Administration
  • Biopsy

Treatment groups

60 Participants
are divided into 1 treatment group

Locations

5
Mayo Clinic in Arizona85259, ScottsdaleArizona, United States
Mayo Clinic in Florida32224-9980, JacksonvilleFlorida, United States
Indiana University Simon Comprehensive Cancer Center46202, IndianapolisIndiana, United States
Mayo Clinic in Rochester55905, RochesterMinnesota, United States

Sponsors and collaborators

Mayo Clinic

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov