Breast Cancer Clinical Trial

Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Summary

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.

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Full Description

PRIMARY OBJECTIVE:

I. Pre- versus (vs) post-intervention change in postpartum-related breast cancer (PRBC) score.

SECONDARY OBJECTIVE:

I. Pre- vs. post-intervention change in postpartum involution (PPI) signature score.

EXPLORATORY OBJECTIVES:

I. Pre- vs. post-intervention change in percent of epithelial cells positive for COX-2, estrogen receptor (ER)/Ki67, gammaH2AX, and p16 in "normal" and in benign breast disease (BBD) lobule.

II. Pre- vs. post-intervention change in serum C-reactive protein (CRP), estrogens, insulin/insulin-like growth factors (IGFs), and adipokines.

III. Pre- vs. post-intervention changes in tissue and urine prostaglandins (PGs) and PGE2.

OUTLINE:

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 orally (PO) daily and undergo collection of blood on study. Patients may undergo ultrasound guided breast biopsy as clinically indicated.

View Eligibility Criteria

Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT05557877

Recruitment Status:

Recruiting

Sponsor:

Mayo Clinic

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There are 3 Locations for this study

See Locations Near You

Mayo Clinic in Arizona
Scottsdale Arizona, 85259, United States More Info
Clinical Trials Referral Office
Contact
855-776-0015
[email protected]
Barbara A. Pockaj, M.D.
Principal Investigator
Mayo Clinic in Florida
Jacksonville Florida, 32224, United States More Info
Clinical Trials Referral Office
Contact
855-776-0015
[email protected]
Sarah McLaughlin, M.D.
Principal Investigator
Mayo Clinic in Rochester
Rochester Minnesota, 55905, United States More Info
Clinical Trials Referral Office
Contact
855-776-0015
[email protected]
Kathryn J. Ruddy, M.D.
Principal Investigator

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

100

Study ID:

NCT05557877

Recruitment Status:

Recruiting

Sponsor:


Mayo Clinic

How clear is this clinincal trial information?

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