Low Dose Aspirin for Postpartum Breast Cancer Prevention
Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer
Recruiting
Phase 2Interventional Study
Breast Carcinoma
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Healthy Volunteers Welcome
You do not need to have the condition being studied to take part.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 – 45
Sex
Female
Trial phase
Phase 2
Study type
Interventional
Purpose
Prevention
Participants needed
60 (estimated)
Sponsor
Mayo Clinic · Other
Who this trial is looking for
This trial is looking for women aged 18 to 45 who have had a baby in the last 10 years and are planning to have a breast biopsy. Participants will take low-dose aspirin and provide blood, urine, and tissue samples for research.
Are You a Good Fit for This Trial?
Must not be takingAspirinNSAIDs
Rules you outDCISInvasive cancer
You may be able to join if
I am 18 to 45 years old.
I have had a live birth in the last 10 years.
I am pre-menopausal.
I can give written consent.
I am willing to provide blood and urine samples.
I can complete questionnaires.
I am willing to provide tissue samples.
I can return for follow-up visits.
You may not be able to join if
I have a history of breast cancer.
I have received treatment for any other cancer.
I am currently taking aspirin or similar medications.
I have a known or suspected breast infection.
I am currently pregnant or trying to get pregnant soon.
I am post-menopausal.
I have any bleeding disorders.
I have a known allergy to non-steroidal anti-inflammatory drugs.
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer a few quick questions to see if you may meet the eligibility requirements.
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 postpa…
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.
Trial Locations
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Eligibility Criteria
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-meno…
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 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 (during the active monitoring phase of the study)
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
* PRE-REGISTRATION: Known or suspected active breast infection
* REGISTRATION: Known DCIS or invasive cancer
* 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
* REGISTRATION: Known or suspected active breast infection
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