EUCTR2018-003896-37-ES进行中（未招募）1 期
A Multinational, Multicenter, Phase 2 Study of Tesetaxel plus a Reduced Dose of Capecitabine in Patients with HER2 Negative, Hormone Receptor Positive, Locally Advanced or Metastatic Breast Cancer Who Have Not Previously Received a Taxane
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 125
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •All of the following criteria must be met:
- •1. Female or male patients at least 18 years of age
- •2. Histologically or cytologically confirmed breast cancer
- •3. HER2 negative disease based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER2 status
- •4. HR (estrogen receptor [ER] and/or progesterone receptor [PgR]) positive disease based on local testing: ASCO/CAP guidelines should be utilized for assessing HR status
- •5. Measurable disease per RECIST 1.1, including bone-only disease with measurable lytic component
- •- Patients with bone-only metastatic cancer must have a measurable lytic or mixed lytic-blastic lesion that can be accurately assessed by computerized tomography (CT) or magnetic resonance imaging (MRI). Patients with bone-only disease without a measurable lytic component (ie, blastic-only metastasis) are not eligible.
- •- Known metastases to the CNS are permitted but not required. The following criteria apply:
- •- Patients must be neurologically stable and either off corticosteroids or currently treated with a maximum daily dose of 4 mg of dexamethasone (or equivalent), with no increase in corticosteroid dose within 7 days prior to Enrollment (defined as the time of Sponsor approval of treatment dose)
- •- Patients with a history of CNS metastases but with no current evidence of CNS lesions following local therapy are eligible
- •- Patients may have CNS metastases that are stable or progressing radiologically
- •- Patients with current evidence of leptomeningeal disease are not eligible
- •- Patients may have untreated brain metastases or previously treated brain metastases, as long as no immediate local CNS-directed therapy is indicated
- •- Any prior whole brain radiation therapy must have been completed > 14 days prior to the date of Enrollment
- •- Prior stereotactic brain radiosurgery is permitted
- •- CNS surgical resection must have been completed > 28 days prior to the date of Enrollment; patient must have complete recovery from surgery
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1, or 2
- •7. Prior endocrine therapy with or without a cyclin-dependent kinase (CDK) 4/6 inhibitor unless endocrine therapy is not indicated (ie, short relapse-free interval while on adjuvant endocrine therapy [endocrine resistance]; rapidly progressing disease/visceral crisis; or endocrine intolerance). Any targeted therapies approved for HER2 negative, HR positive LA/MBC, including everolimus, are permitted as prior therapy. There is no limit to the number of prior endocrine therapies.
- •8. Documented (including de novo): (a) locally advanced breast cancer that is not considered curable by surgery and/or radiation; or (b) metastatic breast cancer
- •9. Adequate hematologic, hepatic, and renal function, as evidenced by:
- •- Absolute neutrophil count (ANC) = 1,500/µL without colony-stimulating factor support
- •- Platelet count = 100,000/µL
- •- Hemoglobin = 10 g/dL without need for hematopoietic growth factor or transfusion support
- •- Total bilirubin < 1.5 × upper limit of normal (ULN); does n
排除标准
- •1. Two or more prior chemotherapy regimens for advanced disease
- •2. Prior treatment with a taxane at any dose
- •3. Prior treatment with capecitabine at any dose
- •4. Current evidence of leptomeningeal disease
- •5. Other cancer that required therapy within the preceding 5 years other than adequately treated: (a) non melanoma skin cancer or in situ cancer; or (b) following approval by the Medical Monitor, other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the Study
- •6. Known human immunodeficiency virus infection, unless well controlled. Patients who are on an adequate antiviral regimen with no evidence of active infection are considered well controlled.
- •7. Active hepatitis B or active hepatitis C infection
- •8. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with Study participation or investigational product administration or may interfere with the interpretation of Study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this Study
- •9. Presence of neuropathy > Grade 1 per NCI CTCAE version 5.0
- •10. Anticancer treatment, including endocrine therapy, radiotherapy (except stereotactic brain radiosurgery), chemotherapy, biologic therapy, or therapy in an investigational clinical study, = 14 days prior to the date of Enrollment
- •11. Major surgery = 28 days prior to the date of Enrollment; patient must have complete recovery from surgery
- •12. Less than 2 weeks or 5 plasma half-lives (whichever is greater) since last use of a medication or ingestion of an agent, beverage, or food that is a known clinically relevant strong inhibitor or known clinically relevant inducer of the cytochrome P450 (CYP)3A pathway (patients should discontinue taking any regularly-taken medication that is a strong inhibitor or inducer of the CYP3A pathway)
- •13. History of hypersensitivity or unexpected reactions to capecitabine, fluoropyrimidine agents or any of their ingredients
- •14. Known dihydropyrimidine dehydrogenase (DPD) deficiency. Testing for DPD deficiency must be performed where required by local regulations, using a validated method that is approved by local health authorities.
- •15. Pregnant or breastfeeding
- •16. If, in the opinion of the Investigator, the patient is deemed unwilling or unable to comply with the requirements of the Study
- •17. Treatment with brivudine, sorivudine, or its chemically-related analogs = 28 days prior to the date of Enrollment
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