Targeted Prevention of Postpartum-Related Breast Cancer

Studying Low-Dose Aspirin's Effect on Inflammation in New Mothers

T
Tarah Ballinger, MD

Primary Investigator

Not Recruiting
18 years - 45 years
Female
Phase 2
24 participants needed
1 Location

Brief description of study

This phase II trial tests whether low-dose aspirin can affect markers of inflammation in postpartum (after childbirth) patients with benign breast disease 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.
 
Interested in participating? For more information about this research study or other cancer-related clinical trials at IU Simon Comprehensive Cancer Center, please contact:
IU Clinical Trials Office 
Phone: (317) 278-5632

Detailed description of study

Patients undergo standard of care breast biopsy for assessment of abnormalities seen on imaging, as well as collection of blood during screening. If cancer is found, patient is taken off study and treatment options are discussed with treating physician.

  • Patients without a cancer finding on biopsy then receive low-dose aspirin PO daily and undergo collection of blood on study. Patients may undergo ultrasound guided breast biopsy as clinically indicated.


 

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: breast cancer, breast carcinoma, benign breast disease, breast fibrocystic change
  • Age: 18 years - 45 years
  • Gender: Female

Inclusion Criteria:

  • PRE-REGISTRATION: Age >= 18 years and =< 45 years of age
  • PRE-REGISTRATION: Presence of lesion suspicious for benign breast disease and planned breast biopsy or planned mammoplasty or other breast surgery (e.g., breast reduction, breast implants, etc.) or willing to have research biopsy or breast biopsy ≤ 12 months prior to pre-registration for benign breast disease with tissue available for research.
  • 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
  • PRE-REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research
  • REGISTRATION: Age >= 18 years and =< 45 years of age
  • REGISTRATION: Histological confirmation of benign breast disease (i.e., no evidence of DCIS or invasive cancer)
  • REGISTRATION: Registration for this study must be completed either =< one (1) year after the qualifying pre-registration biopsy 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 =< 30 days prior to registration)
  • REGISTRATION: Platelet count >= 100,000/mm^3 (obtained =< 30 days prior to registration
  • REGISTRATION: Serum creatinine =< 2.0 mg/dl (obtained =< days prior to registration)
  • REGISTRATION: Negative pregnancy test done =< 14 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
  • REGISTRATION: Known or suspected active breast infection

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 eight 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: 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
  • Known or suspected active breast infection

 

This study investigates the effect of low-dose aspirin on inflammation markers in postpartum patients with benign breast disease. Postpartum refers to the period after childbirth. Chronic inflammation may increase the risk of developing breast cancer after having a baby. Low-dose aspirin is a type of medication that reduces inflammation and might change markers of inflammation in blood and tissue.

Participants will undergo a standard breast biopsy to check for abnormalities seen on imaging. If cancer is found, they will leave the study and discuss treatment with their doctor. Those without cancer will take low-dose aspirin daily and have blood collected during the study. Some may have an ultrasound-guided breast biopsy if needed.

  • Who can participate: Women aged 18 to 45 who had a baby in the last 10 years can join. They need a suspicious lesion for benign breast disease and must be pre-menopausal, without a history of breast cancer or current use of aspirin or similar drugs.
  • Study details: Participants will take low-dose aspirin daily and provide blood and tissue samples for research. A placebo is not used in this study.
Updated on 16 Oct 2025. Study ID: CTO-MC220301, 22486

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