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Targeted Prevention of Postpartum-Related Breast Cancer

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Procedure, Other, Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY

This phase II trial tests whether low-dose aspirin can affect markers of inflammation in postpartum (after childbirth) women 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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

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

• PRE-REGISTRATION: Willingness to provide mandatory tissue specimens for correlative research at two timepoints.

• 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

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

• REGISTRATION: Registration for this study must be completed either =\< one (1) year after the qualifying pre-registration biopsy is 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: Willing to return to enrolling institution for follow-up (during the active monitoring phase of the study)

Locations
United States
Arizona
Mayo Clinic in Arizona
RECRUITING
Scottsdale
Florida
Mayo Clinic in Florida
SUSPENDED
Jacksonville
Indiana
Indiana University Simon Comprehensive Cancer Center
RECRUITING
Indianapolis
Minnesota
Mayo Clinic in Rochester
RECRUITING
Rochester
Contact Information
Primary
Clinical Trials Referral Office
mayocliniccancerstudies@mayo.edu
855-776-0015
Time Frame
Start Date: 2023-03-09
Estimated Completion Date: 2027-01-30
Participants
Target number of participants: 100
Treatments
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 by mouth daily for 42-65 days and undergo collection of blood on study. Patients may undergo breast biopsy as clinically indicated.
Related Therapeutic Areas
Sponsors
Leads: Mayo Clinic
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov