EUCTR2018-004715-41-PL进行中（未招募）1 期
A Multicenter, Phase 2 Study of Tesetaxel plus Three Different PD-(L)1 Inhibitors in Patients with Triple-Negative, Locally Advanced or Metastatic Breast Cancer and Tesetaxel Monotherapy in Elderly Patients with HER2 Negative, Locally Advanced or Metastatic Breast Cancer
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
- 210
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
- 性别
- All
入选标准
- •1. Female or male patients aged:
- •Cohort 1: = 18 years old
- •Cohort 2: = 65 years old
- •2. Histologically or cytologically confirmed breast cancer
- •3. Most recent biopsy must be HER2 negative based on local testing: American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines should be utilized for assessing HER2 status
- •4. Cohort 1 only: Most recent biopsy must be hormone receptor (HR) (estrogen receptor and progesterone receptor) negative based on local testing per ASCO/CAP guidelines
- •5. Measurable disease per RECIST 1.1.
- •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 lytic component (ie, blastic-only metastasis) are not eligible.
- •Known metastases to the CNS are permitted but not required. The following criteria apply:
- •o Patients must be neurologically stable and off corticosteroids for = 7 days
- •o Patients with a history of CNS metastases who have completed local therapy with surgical resection and/or radiation therapy are eligible
- •o Patients may have CNS metastases that are stable or progressing radiologically. If patients have progressive brain metastases, they should be asymptomatic from their CNS disease.
- •o Patients with current evidence of leptomeningeal disease are not eligible
- •o Patients may have untreated brain metastases or previously treated brain metastases, as long as no immediate local CNS-directed therapy is indicated
- •o Any prior whole brain radiation therapy must have been completed > 14 days prior to the date of Enrollment
- •o Prior stereotactic brain radiosurgery is permitted at any time prior to Enrollment
- •o CNS surgical resection must have been completed > 28 days prior to the date of Enrollment; patient must have complete recovery from surgery
- •6. Documented (including de novo): (a) locally advanced breast cancer that is not considered curable by surgery and/or radiation; or (b) metastatic breast cancer (MBC)
- •7. Disease-free interval of at least 12 months after the completion of systemic neoadjuvant or adjuvant chemotherapy for patients previously treated with systemic chemotherapy for a tumor surgically resected with curative intent
- •8. Cohort 2 only: 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 prior targeted therapies are
- •permitted. There is no limit to the number of prior endocrine therapies.
- •9. Cohort 1 only: At Screening, patients must have documented evidence
- •of positive PD-L1 expression as assessed via immunohistochemistry
- •(IHC) scoring by local, regional, or central laboratory testing. In addition
- •to any tissue used for PD-L1 testing to determine eligibility, a tumor
- •block or 15 slides from a newly obtained or archival core or excisional
- •biopsy of a not-previously-irradiated tumor lesion obtained since
- •completion of any systemic therapy (metastatic tumor lesion preferred)
- •must be submitted for central PD-L1 testing. If tumor block or 15 slides
- •are unavailable or if biopsy is thought to be unsafe, discuss with Sponsor
- •whether patient can be enrolled.
- •10. Eastern Cooperative Oncology Group (ECOG) performance status 0,
- •11. Adequate
排除标准
- •1. Prior chemotherapy for locally advanced or metastatic disease
- •2. Cohort 1 only: prior treatment with pembrolizumab, nivolumab, atezolizumab, any other PD-(L)1/PD-L2 inhibitor, or a cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor
- •3. Current evidence or history of leptomeningeal disease
- •4. 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 Sponsor medical team, other cancer that has a very low risk of interfering with the safety or efficacy endpoints of the Study
- •5. 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.
- •6. Known active hepatitis B or known active hepatitis C infection
- •7. 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
- •8. Presence of neuropathy Grade > 1 per NCI CTCAE version 5.0
- •9. History of hypersensitivity to any of the Study drugs or any of their ingredients, as applicable
- •10. Cohort 1 only:
- •Chronic autoimmune disease
- •Evidence of active, non-infectious pneumonia (eg, pneumonia due to autoimmune or connective tissue disease)
- •Treatment with a live vaccine within 30 days prior to the first dose of nivolumab, pembrolizumab, or atezolizumab
- •History of active tuberculosis
- •Prior organ transplantation including allogeneic stem cell transplantation
- •Active infection requiring systemic therapy
- •Current or prior use of immunosuppressive medication within 7 days prior to Cycle 1, Day 1; the following are exceptions to this exclusion criterion:
- •o Intranasal, inhaled, or topical steroids, or local steroid injections (eg, intraarticular injection)
- •o Systemic corticosteroids at physiologic doses = 10 mg/day of prednisone or equivalent
- •o Steroids as premedication for hypersensitivity reactions (eg, CT scan premedication)
- •Active autoimmune disease that might deteriorate when receiving an immunostimulatory agent; patients with Type 1 diabetes, vitiligo, psoriasis, hypothyroid disease, celiac disease or hyperthyroid disease not requiring immunosuppressive treatment are eligible
- •11. Anticancer treatment, including endocrine therapy, radiotherapy (except stereotactic brain radiosurgery), chemotherapy or biologic therapy, = 14 days prior to Enrollment
- •12. Major surgery = 28 days prior to Enrollment; patient must have complete recovery from surgery
- •13. 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)
- •14. Pregnant or breastfeeding
- •15. If, in the opinion of the Investigator, the patient is deemed unwilling or unable to comply with the requirements of the Study
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