Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Overview

About this study

The purpose of this study is to test whether a short course of aspirin can change the markers of inflammation in patients who have a benign finding within five years of their last pregnancy, and possibly reduce their risk of future breast cancer.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 1/16/2025. Questions regarding updates should be directed to the study team contact.
 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Sarah McLaughlin, M.D.

Contact us for the latest status

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Rochester, Minn.

Mayo Clinic principal investigator

Kathryn Ruddy, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

Barbara Pockaj, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

(855) 776-0015

More information

Publications

Publications are currently not available
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CLS-20537872

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