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Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

Sponsor
Mayo Clinic (Other)
Overall Status
Recruiting
CT.gov ID
NCT05557877
Collaborator
National Cancer Institute (NCI) (NIH)
100
Enrollment
1
Location
1
Arm
51.8
Anticipated Duration (Months)
1.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Biospecimen Collection
  • Drug: Low-Dose Aspirin
  • Other: Questionnaire Administration
  • Procedure: Ultrasound-Guided Biopsy
 Phase 2

Detailed Description

PRIMARY OBJECTIVE:
  1. Pre- versus (vs) post-intervention change in postpartum-related breast cancer (PRBC) score.
SECONDARY OBJECTIVE:
  1. Pre- vs. post-intervention change in postpartum involution (PPI) signature score.
EXPLORATORY OBJECTIVES:

  1. 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.

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

  3. 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Targeted Prevention of Postpartum-Related Breast Cancer
Actual Study Start Date :
Oct 7, 2022
Anticipated Primary Completion Date :
Jan 30, 2026
Anticipated Study Completion Date :
Jan 30, 2027

Arms and Interventions

Arm Intervention/Treatment
Experimental: Prevention (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 PO daily and undergo collection of blood on study. Patients may undergo ultrasound guided breast biopsy as clinically indicated.

Procedure: Biospecimen Collection
Undergo collection of blood
Other Names:
  • Biological Sample Collection
  • Biospecimen Collected
  • Specimen Collection

    • Drug: Low-Dose Aspirin
    Given PO
    Other Names:
  • Baby Aspirin

    • Other: Questionnaire Administration
    Ancillary studies

    Procedure: Ultrasound-Guided Biopsy
    Undergo ultrasound-guided breast biopsy
    Other Names:
  • Ultrasound Guided Biopsy

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in pregnancy-related breast cancer (PRBC) score [Pre- versus (vs) post-intervention up to 30 days post interventions.]

      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

    1. Change in postpartum involution (PPI) signature score [Pre- vs. post-intervention up to 30 days post interventions]

      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.

    Other Outcome Measures

    1. 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) lobules [Pre- vs. post-intervention up to 30 days post interventions]

      Will be calculated based on 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.

    2. Change in serum C-reactive protein (CRP), estrogens, insulin/insulin-like growth factors (IGFs), and adipokines [Pre- vs. post-intervention up to 30 days post interventions]

      Will be measured pre- and post-intervention for each person. Within person differences will be analyzed. The correlation between the change in PRBC score and change in the respective serum measures will be assessed using a Pearson correlation if both the values are normally distributed.

    3. Changes in tissue and urine prostaglandins (PGs) and PGE2 [Pre- vs. post-intervention up to 30 days post interventions]

      Will be measured pre- and post-intervention for each person. Within person differences will be analyzed. The correlation between the change in PRBC score and change in the respective PGs will be assessed using a Pearson correlation if both the values are normally distributed.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 45 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • PRE-REGISTRATION: Age >= 18 years and =< 45 years of age

    • PRE-REGISTRATION: Presence of lesion suspicious for benign breast disease on mammography and planned breast biopsy

    • PRE-REGISTRATION: Had a live birth =< 5 years prior to pre-registration

    • PRE-REGISTRATION: Pre-menopausal

    • 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 must be completed =< 30 days after pre-registration biopsy performed 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 =< 7 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

    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 four 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

    • REGISTRATION: No research tissue collected during pre-registration biopsy performed for this study

    • 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 malignancy requiring 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mayo Clinic in Rochester Rochester Minnesota United States 55905

    Sponsors and Collaborators

    • Mayo Clinic
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Kathryn J Ruddy, Mayo Clinic in Rochester

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mayo Clinic
    ClinicalTrials.gov Identifier:
    NCT05557877
    Other Study ID Numbers:
    • MC220301
    • NCI-2022-07430
    • P30CA015083
    • R01CA262393
    First Posted:
    Sep 28, 2022
    Last Update Posted:
    Jan 5, 2023
    Last Verified:
    Oct 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Breast Neoplasms
    Fibrocystic Breast Disease
    Aspirin

    Study Results

    No Results Posted as of Jan 5, 2023