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Low Dose Aspirin for the Prevention of Postpartum Related Breast Cancer

StatusRecruiting
PhasePhase 2
Started2023-03-09
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 6 months later Jan 30, 2027 → Jul 30, 2027
See other at-risk trials from Mayo Clinic

Amendment history

2026-10-02
Primary completion pushed: 2027-01-30 → 2027-07-30
Completion pushed: 2027-01-30 → 2027-07-30
2026-08-18
Study Status, Contacts/Locations v20
Study sitesdetails revised at 1 of 5 sites
2026-06-15
Study Status, Contacts/Locations v19
Study sitesdetails revised at 1 of 5 sites
2026-06-10
Study Status v18
Re-verified, no change to tracked fields
2026-05-08
Study Status, Study Design, Eligibility, Contacts/Locations v17
Enrollment reduced: 100 → 60 participants
Study sites4→5
Eligibility criteria+92 characters
[...] is study) REGISTRATION: Hemoglobin >= 9.0 g/dL (obtained =< 3090 days prior to registration) REGISTRATION: Platelet count >= 100,000/mm^3 (obtained =< 3090 days prior to registration REGISTRATION: Serum creatinine =< 2.0 mg/dl (obtained =< 90 days prior to registration) REGISTRATION: Negative pregnancy test done =< 1415 days prior to registration REGISTRATION: Willing to use con [...] andatory 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 [...]
2026-03-26
Study Identification, Study Status v16
Primary completion pushed: 2026-01-30 → 2027-01-30
2026-01-02
Study Status v15
Primary completion date2027-01-30→2026-01-30
2025-12-30
Study Status v14
Re-verified, no change to tracked fields
2025-09-30
Study Status v13
Primary completion date2026-01-30→2027-01-30
2025-01-24
Study Status, Study Description, Conditions, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v12
InterventionsBiospecimen Collection (Procedure), Low-Dose Aspirin (Drug), Questionnaire Administration (Other), Ultrasound-Guided Biopsy (Procedure)→Biopsy (Procedure), Biospecimen Collection (Procedure), Low-Dose Aspirin (Drug), Questionnaire Administration (Other)
Eligibility criteria-476 characters
Inclusion Criteria: PRE-REGISTRATION: Age >= 18 years and =< 45 years of age PRE-REGISTRATION: PresenceWillingness ofto lesionprovide suspiciousmandatory tissue specimens for benign breast disease and planned breast biopsy or planned mammoplasty or other breast surgery (e.g., breast reduction, breast implants, etc.) or willing to havecorrelative research biopsyat ortwo breast biopsy ≤ 12 months prior to pre-registration for benign breast disease with tissue available for researchtimepoints. PRE-REGISTRATION: Had a live birth =< 10 years prior to pr [...] andatory blood and urine specimens for correla [...]
Secondary endpointsdetails revised at 1 of 1 entry
Study description+58 characters
PRIMARY OBJECTIVE: I. Pre- versus (vs.) post-intervention change in postpartumpost-partum-related breast cancer (PRBC) score. SECONDARY OBJECTIVE: I. [...] d undergo collection of blood on study. Patients may undergo ultrasound guided breast biopsy as clinically indicated. After completion of study treatment, patients are followed up at 30 days.
Study sitescontacts updated at 3 of 4 sites
2024-12-02
Study Identification, Study Status, Contacts/Locations v11
Start date2023-02-14→2023-03-09
Study sites3→4
2024-06-19
Study Identification, Study Status, Contacts/Locations v10
Study sitesdetails revised at 1 of 3 sites
2024-04-22
Study Status, Arms and Interventions, Eligibility v9
Eligibility criteria+129 characters
[...] ious for benign breast disease and planned breast biopsy or Breastplanned mammoplasty or other breast surgery (e.g., breast reduction, breast implants, etc.) or willing to have research biopsy =<or breast biopsy ≤ 12 months prior to pre-registration for benign breast disea [...]
2023-10-04
Study Status, Oversight, Eligibility, Contacts/Locations v8
Eligibility criteria+63 characters
[...] RATION: Registration for this study must be completed either =< one (1) year after the qualifying pre-registration biopsy performed for this study or =< one (1) year after collection of the archived tissue (for t [...] N: Willing to return to enrolling institution for follow-up REGISTRATION: Known or suspected active breast infection Exclusion Criteria: PRE-REGISTRATION: History of breast canc [...]
2023-09-13
Study Status, Eligibility v7
Eligibility criteria+487 characters
[...] ON: Presence of lesion suspicious for benign breast disease on mammography and planned breast biopsy or Breast biopsy =< 12 months prior to pre-registration for benign breast disease with tissue available for research. PRE-REGISTRATION: Had a live birth =< 10 years prior to pre [...] dence of DCIS or invasive cancer) REGISTRATION: Registration for this study must be completed =<either 30one days(1) year after the qualifying pre-registration biopsy 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- [...] [...]
2023-09-01
Study Identification, Study Status, References v6
2023-05-18
Study Identification, Study Status, Arms and Interventions, Outcome Measures, Eligibility, Contacts/Locations v5
Start date2023-03-09→2023-02-14
Study sites1→3
Eligibility criteria+61 characters
[...] planned breast biopsy PRE-REGISTRATION: Had a live birth =< 510 years prior to pre-registration PRE-REGISTRATION: Pre-menopausal according to patient report and/or clinical determination PRE-REGISTRATION: Provide written informed consent PRE-REGI [...] registration) REGISTRATION: Negative pregnancy test done =< 714 days prior to registration REGISTRATION: Willing to use con [...] within =< 5 days prior to pre-registration and no more than foureight doses within =< 30 days prior to pre-registration) PRE-REGI [...]
Secondary endpointsdetails revised at 1 of 1 entry
2023-04-20
Study Status v4
Start date2023-02-14→2023-03-09
2023-02-15
Study Status v3
Start date2022-10-07→2023-02-14
2023-01-04
Study Identification, Study Status v2
Re-verified, no change to tracked fields
2022-10-10
Not Yet Recruiting→Recruiting Study Status, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Start dateestimated 2022-09-30→confirmed 2022-10-07
Study sitesdetails revised at 1 of 1 site
2022-09-26
Original filing
Mayo Clinic
1,015 trials monitored
See 115 trials at risk
Breast Cancer
5,180 trials monitored
See 256 trials at risk
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 Details
NCT Number NCT05557877
Lead Sponsor Mayo Clinic
Collaborators: National Cancer Institute (NCI)
Conditions Breast Carcinoma
Enrollment 60 participants
Start Date 2023-03-09
Primary Completion 2027-07-30 (estimated)
Study Completion 2027-07-30 (estimated)
Updated on ClinicalTrials.gov 2026-10-01