EUCTR2014-005017-23-ES进行中（未招募）不适用
eo-Adjuvant study with the PDL1-directed antibody in Triple Negative Locally Advanced Breast Cancer undergoing treatment with nab-paclitaxel and carboplatin - NeoTRIPaPDL1
Fondazione Michelangelo - Avanzamento dello studio e cura dei tumori0 个研究点目标入组 272 人开始时间: 2015年11月25日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 272
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
- Female
入选标准
- •1.Female patients aged 18 years or older
- •2.Locally advanced or inflammatory breast cancers (stage III A-C according to AJCC) suitable for neoadjuvant Treatment
- •3.Histologically confirmed unilateral breast cancer with invasive ductal histology
- •4.HER2 negative disease (defined as 0-1+ by immunohistochemistry or 2+ by immunohistochemistry without HER2 amplification by either In Situ Hybridization (ISH) or other amplification tests done locally)
- •5.Negative estrogen receptor (ER) and progesterone receptor (PgR), both < 1% locally assessed
- •6.Representative paraffin-embedded (FFPE) tumor block taken at diagnostic biopsy for confirmation of HER2, ER and PgR eligibility, for assessment of PDL-1 expression and for further exploratory biomarker evaluation is mandatory. Note: FFPE tumor blocks are also mandatory after the first cycle of therapy; surgery tissue (residual tumor or tumor bed in case of pCR) is also mandatory
- •7.ECOG performance status 0 or 1
- •8.Written informed consent to participate in the trial (approved by the Institutional Review Board [IRB]/ Independent Ethics Committee [IEC]) obtained prior to any study specific screening procedures
- •9.Willing and able to comply with the protocol
- •10.Consent to the collection of blood samples mandatorily before starting neoadjuvant treatment, after the first cycle of therapy, at the end of neoadjuvant treatment (before surgery), at the end of adjuvant chemotherapy and once a year for 2 years during follow-up
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 272
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 272
排除标准
- •1.Evidence of bilateral breast cancer or metastatic disease (M1)
- •2.Cases with an histology different from invasive ductal NOS of high proliferation or grade
- •3.Patients with HER2-positive disease according to ASCO/CAP guidelines 2013 (defined as IHC 3+ or ISH positive according to the Guidelines) are considered not eligible for the study
- •4.Pregnant or lactating women.
- •5.Previous treatment with chemotherapy, hormonal therapy or an investigational drug for any type of malignancy
- •6.Previous investigational treatment for any condition within 4 weeks of randomization date
- •7.Administration of a live,attenuated vaccine within 4 weeks before cycle 1 Day 1 or anticipation that such a live attenuated vaccine will be required during the study
- •8.Previous or concomitant invasive malignancy of any other type or previous invasive breast cancer or curatively treated basal cell carcinoma of the skin or in situ cervix cancer are generally eligible
- •9.Pre-existing motor or sensory neuropathy of grade > 1 for any reason
- •10.History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins
- •11.Known hypersensitivity or allergy to biopharmaceuticals produced in Chinese hamster ovary cells or any component of the MPDL3280A formulation
- •12.Patients with prior allogeneic stem cell or solid organ transplantation
- •13.History of autoimmune disease including, but not limited to, systemic lupus erythematosus, heumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, Wegener?s granulomatosis, Sjögren?s syndrome, Bell?s palsy, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis
- •14.History of idiopathic pulmonary fibrosis (including bronchiolitis obliterans with organizing pneumonia) or evidence of active pneumonitis on screening chest computed tomography scan
- •15.Known clinically significant liver disease, including active viral, alcoholic, or other hepatitis, cirrhosis, fatty liver, and inherited liver disease
- •16.History of HIV infection, active hepatitis B (chronic or acute), or hepatitis C infection. Patients with past or resolved hepatitis B infection (defined as having a negative HBsAg test and a positive hepatitis B core antigen [anti-HBc] test) are eligible. Patients positive for hepatitis C virus (HCV) antibody are eligible only if polymerase chain reaction assay (PCR) is negative for HCV RNA
- •17.Active tuberculosis
- •18.Severe infections within 4 weeks prior to cycle 1 Day 1, including, but not limited to, ospitalization for complications of infection, bacteremia, or severe pneumonia. Signs or symptoms of significant infection within 2 weeks prior to cycle 1 Day 1
- •19.Received oral or IV antibiotics within 2 weeks prior to Cycle 1 Day 1
- •20.History of documented congestive cardiac failure; New York Heart Association (NYHA) Class II or greater CHF; angina pectoris requiring anti-anginal medication or unstable angina within 6 months prior to cycle 1 Day 1; evidence of transmural infarction on ECG; myocardial infarction stroke or transient ischemic attack (TIA) within 6 months prior to cycle 1 Day 1; poorly controlled hypertension (e.g. systolic >180 mm Hg or diastolic >100 mm Hg; however, patients with hypertension which is well controlled on medication are eligible); clinically significant valvular heart disease; high-risk uncontrolled arrhythmias
- •21.Patients with a history of uncontrolled seizures, central nervous system
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