Targeted Prevention of Postpartum-Related Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- Mayo Clinic
- 入组人数
- 60
- 试验地点
- 10
- 主要终点
- Change in pregnancy-related breast cancer (PRBC) score
研究概览
简要总结
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.
详细描述
PRIMARY OBJECTIVE:
I. Pre- versus (vs.) post-intervention change in post-partum-related breast cancer (PRBC) score.
SECONDARY OBJECTIVE:
I. Pre- vs. post-intervention change in postpartum involution (PPI) signature score.
EXPLORATORY OBJECTIVES:
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Biospecimen Collection (Procedure)
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.
干预措施: Low-Dose Aspirin (Drug)
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.
干预措施: Biopsy (Procedure)
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.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Change in pregnancy-related breast cancer (PRBC) score
时间窗: Up to 30 days
Assessed using pre- versus post-treatment PRBC scores. Patients who are eligible, consented, received at least 70% of the study treatment, and provided both a pre- and post-intervention tissue specimen will be evaluated for this outcome.
次要结局
- Change in postpartum involution (PPI) signature score(Up to 30 days)