Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Trial Title: Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

NCT ID: NCT05557877

Condition: Benign Breast Neoplasm
Breast Carcinoma
Breast Fibrocystic Change

Conditions: Official terms:
Breast Neoplasms
Fibrocystic Breast Disease
Aspirin

Study type: Interventional

Study phase: Phase 2

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Prevention

Masking: None (Open Label)

Intervention:

Intervention type: Procedure
Intervention name: Biospecimen Collection
Description: Undergo collection of blood
Arm group label: Prevention (low-dose aspirin)

Other name: Biological Sample Collection

Other name: Biospecimen Collected

Other name: Specimen Collection

Intervention type: Drug
Intervention name: Low-Dose Aspirin
Description: Given PO
Arm group label: Prevention (low-dose aspirin)

Other name: Baby Aspirin

Intervention type: Other
Intervention name: Questionnaire Administration
Description: Ancillary studies
Arm group label: Prevention (low-dose aspirin)

Intervention type: Procedure
Intervention name: Ultrasound-Guided Biopsy
Description: Undergo ultrasound-guided breast biopsy
Arm group label: Prevention (low-dose aspirin)

Other name: Ultrasound Biopsy

Other name: Ultrasound Guided Biopsy

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.

Criteria for 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

Gender: Female

Minimum age: 18 Years

Maximum age: 45 Years

Healthy volunteers: No

Locations:

Facility:
Name: Mayo Clinic in Arizona

Address:
City: Scottsdale
Zip: 85259
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Referral Office

Phone: 855-776-0015
Email: mayocliniccancerstudies@mayo.edu

Investigator:
Last name: Barbara A. Pockaj, M.D.
Email: Principal Investigator

Facility:
Name: Mayo Clinic in Florida

Address:
City: Jacksonville
Zip: 32224-9980
Country: United States

Status: Suspended

Facility:
Name: Mayo Clinic in Rochester

Address:
City: Rochester
Zip: 55905
Country: United States

Status: Recruiting

Contact:
Last name: Clinical Trials Referral Office

Phone: 855-776-0015
Email: mayocliniccancerstudies@mayo.edu

Investigator:
Last name: Kathryn J. Ruddy, M.D.
Email: Principal Investigator

Start date: February 14, 2023

Completion date: January 30, 2027

Lead sponsor:
Agency: Mayo Clinic
Agency class: Other

Collaborator:
Agency: National Cancer Institute (NCI)
Agency class: NIH

Source: Mayo Clinic

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05557877
https://www.mayo.edu/research/clinical-trials