A Pilot Study of Sequential ("First Strike, Second Strike") Therapies, Modeled on Evolutionary Dynamics of Anthropocene Extinctions, for Hormone Positive Metastatic Breast Cancer

H. Lee Moffitt Cancer Center and Research Institute1 个研究点分布在 1 个国家目标入组 15 人开始时间: 2024年8月14日最近更新: 2025年12月4日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方: H. Lee Moffitt Cancer Center and Research Institute
入组人数: 15
试验地点: 1
主要终点: Feasibility of Sequential Therapy

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of the study is to test a treatment strategy with currently approved drugs to see if it is practical to administer the available drugs in a new way that researchers hope could be more effective in treating metastatic breast cancer.

研究设计

研究类型: Interventional
分配方式: Na
干预模型: Sequential
主要目的: Treatment
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: Female
接受健康志愿者: 否

入选标准

•Female patients 18 years or older
•Histologically or cytologically confirmed diagnosis of hormone positive HER2 negative metastatic breast cancer per ASCO/CAP criteria (Allison et al, 2020, Wolff et al, 2018), with diagnosis established through either a breast/axillary biopsy or biopsy of a metastatic lesion.
•Hormone positive MBC previously treated with endocrine therapy with either an aromatase inhibitor or Tamoxifen (alone or in combination with a CDK4/6 inhibitor).
•Elevated breast tumor markers which may include cancer antigen 15-3 (CA 15-3) levels above the institutional upper limit of normal (ULN) range of 0.0-31.0 U/mL, cancer antigen 27-29 (CA 27-29) (range <38 U/mL) and/or elevated Carcinoembryonic antigen (CEA) above institutional upper limit of normal (range 0.0 - 5.2 ng/mL).
•Presence of measurable disease on imaging via RECIST v1.
•ECOG performance status 0-
•Participants must have adequate organ and marrow function as defined in the protocol.
•A negative pregnancy test for pre-menopausal women of childbearing potential.
•Pre-menopausal women of childbearing potential who are sexually active with a male partner must agree to use adequate contraception prior to the study, for the duration of study participation.
•Inclusion of minorities: patients of all races and ethnic groups who meet the above inclusion and below exclusion criteria are eligible for this trial.
•Stated willingness to comply with all study procedures and availability for the duration of the study.
•Ability to understand and the willingness to sign a written informed consent document or have a legally authorized representative sign on the participant's behalf.

排除标准

•Have previously received Fulvestrant for treatment of their breast cancer.
•History of allergic reactions attributed to the study drugs.
•Documented brain metastasis or active or newly diagnosed CNS metastases, including meningeal carcinomatosis, because systemic treatment would need to be paused for these patients.
•Treatment with any investigational compound within 30 days prior to the first dose of study drugs or during this study.
•Diagnosis or treatment for another systemic malignancy within 2 years before the first dose of study drugs, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.
•Uncontrolled intercurrent illness including-but not limited to-ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
•Patients with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term, including massive uncontrolled effusions (peritoneal, pleural, pericardial), pulmonary lymphangitis.
•Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome.
•Active infection including tuberculosis, hepatitis B (known positive HBV surface antigen [HBsAg]), or hepatitis C (HCV). Participants with a past or resolved HBV infection (defined as the presence of hepatitis B core antibody [anti-HBc] and absence of HBsAg) are eligible. Participants with positive HCV antibody are eligible if polymerase chain reaction is negative for HCV RNA.
•Concurrent or prior use of immunosuppressive medication within 14 days before the first dose of study drugs, with the following exceptions: premedication with dexamethasone, intranasal, inhaled, topical or local steroid injections, systemic corticosteroids at physiologic doses not exceeding 10 mg/day of prednisone or its equivalent; steroids as premedication for hypersensitivity reactions (e.g., premedication for iodinated contrast allergy before CT scan).
•Inability to comply with protocol requirements.
•Pregnant and/or breastfeeding women are excluded.