Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Phase 2

Recruiting

• Conditions: Breast Carcinoma; Breast Fibrocystic Change; Benign Breast Neoplasm
• Interventions: Procedure: Biospecimen Collection; Drug: Low-Dose Aspirin; Other: Questionnaire Administration; Procedure: Ultrasound-Guided Biopsy

• Registration Number: NCT05557877
• Lead Sponsor: Mayo Clinic

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-09-26
• Study First Posted: 2022-09-28
• Study Start: 2023-03-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2026-01-30
• Study Completion: 2027-01-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 100

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Prevention (low-dose aspirin)	Low-Dose Aspirin	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 by mouth daily for 42-65 days and undergo collection of blood on study. Patients may undergo ultrasound guided breast biopsy as clinically indicated.
Prevention (low-dose aspirin)	Ultrasound-Guided Biopsy	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 by mouth daily for 42-65 days and undergo collection of blood on study. Patients may undergo ultrasound guided breast biopsy as clinically indicated.
Prevention (low-dose aspirin)	Biospecimen Collection	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 by mouth daily for 42-65 days and undergo collection of blood on study. Patients may undergo ultrasound guided breast biopsy as clinically indicated.
Prevention (low-dose aspirin)	Questionnaire Administration	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 by mouth daily for 42-65 days and undergo collection of blood on study. Patients may undergo ultrasound guided breast biopsy as clinically indicated.

Primary Outcome Measures

Name	Time	Method
Change in pregnancy-related breast cancer (PRBC) score	Pre- versus (vs) post-intervention up to 30 days	Will transform the biomarkers using Van der Waerden rank transformations. Will analyze data as within person differences for pre- versus post-treatment PRBC scores in tissues. The final mean difference in PRBC score point estimate and corresponding 95% confidence interval will be reported.

Secondary Outcome Measures

Name	Time	Method
Change in postpartum involution (PPI) signature score	Pre- vs. post-intervention up to 30 days	Will be calculated pre- and post-intervention for each person. Within person differences will be analyzed. The correlation between the change in PRBC score and change in PPI signature will be assessed using a Pearson correlation if both the scores are normally distributed. If either score is non-normally distributed, a Spearman correlation will be used instead. The correlation coefficient point estimate and 95% confidence interval will be reported.

Trial Locations

Locations (4)

Indiana University Simon Comprehensive Cancer Center; 🇺🇸 Indianapolis, Indiana, United States

Mayo Clinic in Arizona; 🇺🇸 Scottsdale, Arizona, United States

Mayo Clinic in Florida; 🇺🇸 Jacksonville, Florida, United States

Mayo Clinic in Rochester; 🇺🇸 Rochester, Minnesota, United States