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Prevention study for Breast Carcinoma
Official title Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer
ClinicalTrials.gov ID: NCT05557877
What this study is testing
What is Low-Dose Aspirin?
Low-Dose Aspirin is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for breast carcinoma.
Also referred to as Baby Aspirin.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- 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: Currently taking other agents for the prevention of breast cancer
- PRE-REGISTRATION: Currently taking anticoagulants
- PRE-REGISTRATION: Contraindication for aspirin use
See the full eligibility 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...
- 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)
- 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: 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Scottsdale, Arizona, United States
- Jacksonville, Florida, United States
- Indianapolis, Indiana, United States
- Rochester, Minnesota, United States
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Scottsdale, Arizona, United States; Jacksonville, Florida, United States; Indianapolis, Indiana, United States; Rochester, Minnesota, United States; Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.