Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer (NCT05557877) | Clinical Trial Compass
RecruitingPhase 2
Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer
United States60 participantsStarted 2023-03-09
Plain-language 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.
Who can participate
Age range
18 Years – 45 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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 =\< 90 days prior to registration)
* REGISTRATION: Platelet count \>= 100,000/mm\^3 (obtained =\< 90 days prior to registration
* REGISTRATION: Serum creatinine =\< 2.0 mg/dl (obtained =\< 90 days prior to registration)
* REGISTRATION: Negative pregnancy test done =\< 15 days prior to registration
* REGISTRATION: Willing to use contraception while on treatment
* REGISTRATION: Provide written informed consent
* REGISTRATION: Ability to complete questionnai…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is studying whether low-dose aspirin can help prevent postpartum-related breast cancer — does my personal breast cancer risk profile or family history make this kind of prevention strategy worth discussing for me?
2Since this is a Phase 2 trial, the main goal is still to understand how well aspirin changes a specific pregnancy-related breast cancer score, not yet to confirm it prevents cancer — what does that mean for how much we actually know about whether it works or is safe at this stage?
3The trial is measuring something called a 'pregnancy-related breast cancer score' as its main outcome — can you explain what that score represents and whether a change in it is a reliable early signal of reduced cancer risk, or just a preliminary marker?
4Taking low-dose aspirin regularly after pregnancy carries some known risks like gastrointestinal effects — how would you weigh those risks against the potential benefit for someone in my situation, especially if I'm breastfeeding or recently postpartum?
5Are there standard monitoring approaches or other preventive options already available for postpartum breast cancer risk that I should consider alongside or instead of enrolling in this trial?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in pregnancy-related breast cancer (PRBC) score