EUCTR2013-001352-34-CZ进行中（未招募）1 期
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280014 PLUS PACLITAXEL VERSUS TRASTUZUMAB PLUS PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH HER2-POSITIVE 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）
- 发起方
- Pfizer Inc,
- 入组人数
- 702
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. (Where required by regulations, consent from a legally acceptable representative is required for all patients who are younger than 20 years of age.)
- •2. Histologically confirmed diagnosis of breast cancer.
- •3. Presence of metastatic disease.
- •4. Prior documentation of HER2 gene amplification or overexpression by one of the following:
- •a. Gene amplification by fluorescent in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) (as defined by the manufacturer’s kit instruction); OR
- •b. Overexpression by immunohistochemistry (IHC) categorized as IHC3+; OR
- •c. Overexpression by immunohistochemistry categorized as IHC2+ with FISH or CISH confirmation.
- •Determination of HER2 positive status using one of the Sponsor accepted analytical test methods listed in Appendix 1 of the protocol must be documented in the patient’s source documentation.
- •If HER2 status is unavailable or was determined using a test other than a Sponsor-approved assay, eligibility must be documented by the Sponsor-provided central laboratory prior to randomization.
- •5. Available tumor tissue (ie, formalin fixed-paraffin embedded blocks or unstained slides) for central review of HER2 status. Tumor tissue should be from metastatic disease or, if not obtainable, may be from the primary tumor at the time of diagnosis.
- •6. Documentation of ER status (positive or negative) based on local laboratory or Sponsor-identified central laboratory.
- •7. At least 1 measurable lesion as defined by RECIST 1.1, in the assessment of the investigator; measurable lesions must be outside prior radiation fields. The following kinds of lesions are not measurable according to RECIST 1.1: ascites, pleural or pericardial effusion, osteoblastic or osteolytic bone metastases, and carcinomatous lymphangitis of the lung.
- •8. Eastern Cooperative Oncology Group (ECOG) status of 0 to 2 (as per Appendix 2 of the protocol).
- •9. Left ventricular ejection fraction (LVEF) within institutional range of normal, measured by either two dimensional echocardiogram (ECHO) or multigated acquisition (MUGA) scan.
- •10. Screening laboratory values within the following limits:
- •a. Absolute neutrophil count (ANC) =1.5 x 109 cells/L (1500/mm3);
- •b. Platelet count =100 x 109cells/L (100,000/mm3);
- •c. Hemoglobin =9.0 g/dL (90 g/L);
- •d. Serum creatinine =1.5 x upper limit of normal (ULN);
- •e. Total bilirubin =1.5 x ULN (<3 ULN if Gilbert’s disease);
- •f. Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) =2.5 x ULN (=5 x ULN if liver metastases are present).
- •11. Recovery (to grade 1 or baseline) from all clinically significant adverse effects of prior therapies (excluding alopecia).
- •12. Patients of childbearing potential must agree to use a highly effective method of contraception throughout the study and for 12 months after the last dose of assigned treatment. A patient is of childbearing potential if, in the opinion of the investigator, she is biologically capable of having children and is sexually active.
- •13. Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
- •14. Patients who are willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
- •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 Num
排除标准
- •1. Patients who are investigational site staff members directly involved in the conduct of the trial and their family members, site staff members otherwise supervised by the Investigator, or patients who are Pfizer employees directly involved in the conduct of the trial.
- •2. Relapse within 1 year of last dose of previous adjuvant (including neoadjuvant) treatment.
- •3. Prior systemic therapy for metastatic disease (except endocrine therapy).
- •4. Prior cumulative dose of doxorubicin of >400 mg/m2, epirubicin dose >800 mg/m2, or the equivalent dose for other anthracyclines or derivatives (e.g., 72 mg/m2 of mitoxantrone). If the patient has received more than one anthracycline, then the cumulative dose must not exceed the equivalent of 400 mg/m2 of doxorubicin.
- •5. Inflammatory breast cancer.
- •6. Superficial disease site that cannot be assessed by radiographic method as the only site of measurable disease. Patients with superficial lesions that can be measured by computed tomography (CT) scan or magnetic resonance imaging (MRI) are eligible.
- •7. Major surgery, radiotherapy, or any investigational agents, within 4 weeks before the administration of the first dose of study treatment.
- •8. Concurrent administration of other anticancer therapies. Bisphosphonate therapy for pre-existing bone metastases or osteoporosis is allowed; prophylactic use to prevent bone metastasis is exclusionary.
- •9. Active uncontrolled or symptomatic central nervous system (CNS) metastases, as evidenced by clinical symptoms, cerebral edema, and/or progressive growth. Patients with a history of CNS metastases or cord compression are eligible if they have completed definitive treated and have not received anticonvulsants or steroids for at least 4 weeks before first dose of study treatment. Patients with newly detected asymptomatic CNS metastases must complete definitive treatment (e.g., radiotherapy, stereotactic surgery) before being considered for study entry. Patients with a history of carcinomatous meningitis (leptomeningeal disease) are not eligible.
- •10. Active uncontrolled cardiac disease, including cardiomyopathy, congestive heart failure (CHF) New York Heart Association (NYHA) functional classification of =3, unstable angina, or myocardial infarction within 12 months before first dose of study treatment.
- •11. Preexisting grade 2 or greater motor or sensory neuropathy.
- •12. History of severe hypersensitivity reaction to taxanes, trastuzumab, murine proteins, or excipients in their formulations.
- •13. Clinical contraindication to treatment with steroids preventing use as part of paclitaxel premedication.
- •14. Pregnant females; breastfeeding females; females of childbearing potential who are unwilling or unable to use a highly effective method of contraception as outlined in this protocol for the duration of the study and for 12 months after last dose of investigational product.
- •15. Known or demonstrated viral infection as listed below. Testing to demonstrate eligibility is required only in countries where regulations mandate testing. In all other countries, testing should be considered if a patient is at risk for having undiagnosed infection (for example due to history of injection drug use or due to geographic location).
- •a. Seropositivity for human immunodeficiency virus (HIV);
- •b. Current or chronic hepatitis B and/or hepatitis C infection (as detected by positive testing for hepatitis B surface antigen [HbsAg] or antibody to hepatitis C virus [an
研究者
相似试验
进行中（未招募）
1 期
DOUBLE-BLIND STUDY OF PF-05280014 PLUS PACLITAXEL VERSUS TRASTUZUMAB PLUS PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCERMedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Metastatic Breast CancerEUCTR2013-001352-34-PTPfizer Inc,702
已完成
不适用
A PHASE 3 RANDOMIZED, DOUBLE-BLIND STUDY OF PF-05280014 PLUS PACLITAXEL VERSUS TRASTUZUMAB PLUS PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCER-C50 Malignant neoplasm of breastMalignant neoplasm of breastC50PER-010-14PFIZER S.A.,8
进行中（未招募）
1 期
DOUBLE-BLIND STUDY OF PF-05280014 PLUS PACLITAXEL VERSUS TRASTUZUMAB PLUS PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCERMetastatic Breast CancerEUCTR2013-001352-34-HUPfizer Inc,702
进行中（未招募）
1 期
DOUBLE-BLIND STUDY OF PF-05280014 PLUS PACLITAXEL VERSUS TRASTUZUMAB PLUS PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCERMetastatic Breast CancerEUCTR2013-001352-34-LVPfizer Inc,702
进行中（未招募）
1 期
DOUBLE-BLIND STUDY OF PF-05280014 PLUS PACLITAXEL VERSUS TRASTUZUMAB PLUS PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS WITH HER2-POSITIVE METASTATIC BREAST CANCERMedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Metastatic Breast CancerEUCTR2013-001352-34-PLPfizer Inc,702