EUCTR2011-002132-10-IT进行中（未招募）1 期
A randomized, two-arm, open-label, multicenter Phase II trialassessing the efficacy and safety of pertuzumab given in combinationwith trastuzumab plus an aromatase inhibitor in first line patients withHER2-positive and hormone receptor-positive advanced (metastatic orlocally advanced) breast cancer. - PERTAI
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- ROCHE
- 入组人数
- 258
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. Signed written informed consent approved by the Institutional Ethical
- •Review Board (IRB).
- •2. Age greater than or equal to 18 years.
- •3. Postmenopausal status >1 year (fulfilling one or more of National Comprehensive Cancer Network [NCCN] guideline criteria, Version 2.2011).
- •4. Histologically or cytologically confirmed and documented
- •adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection.
- •5. HER2-positive (defined as either IHC 3+ or ISH positive) as assessed by local laboratory on primary or metastatic tumor (ISH positivity is defined as a ratio of 2.0 or greater for the number of HER2 gene copies to the number of signals for CEP17, or for single probe tests, a HER2 gene count greater than 4).
- •6. Hormone receptor-positive defined as ER-positive and/or PgR-positive assessed locally as defined by institutional criteria.
- •7. At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1 (Eisenhauer et al. 2009).
- •8. ECOG performance status 0 or 1.
- •9. Left ventricular ejection fraction (LVEF) of at least 50%.
- •10. Life expectancy of at least 12 weeks.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 150
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 100
排除标准
- •1. Previous systemic non-hormonal anticancer therapy in the metastatic or locally advanced breast cancer setting.
- •2. Disease-free interval from completion of adjuvant or neo-adjuvant
- •systemic non-hormonal treatment to recurrence of within 6 months.
- •3. Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the neoadjuvant or adjuvant setting.
- •4. Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant setting.
- •5. History of persistent grade 2 or higher (NCI-CTC, Version 4.0) hematological toxicity resulting from previous adjuvant or neo-adjuvant therapy.
- •6. Radiographic evidence of central nervous system (CNS) metastases as assessed by CT or MRI.
- •7. Current peripheral neuropathy of grade 3 or higher (NCI-CTC, Version
- •8. History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix or basal cell carcinoma.
- •9. Serious uncontrolled concomitant disease that would contraindicate
- •the use of any of the investigational drugs used in this study or that
- •would put the patient at high risk for reatment related complications.
- •10. Inadequate organ function, evidenced by the following laboratory results:
- •Absolute neutrophil count <1,500 cells/mm3.
- •Platelet count <100,000 cells/mm3.
- •Hemoglobin <9 g/dL.
- •Total bilirubin greater than the upper limit of normal (ULN) unless the
- •patient has documented Gilbert's syndrome).
- •AST (SGOT) or ALT (SGPT) >2.5 × ULN.
- •AST (SGOT) or ALT (SGPT) >1.5 × ULN with concurrent serum alkaline
- •phosphatase >2.5 × ULN Serum alkaline phosphatase may be >2.5 ×
- •ULN only if bone metastases are present and AST
- •(SGOT) and ALT (SGPT) <1.5 × ULN.
- •Serum creatinine >2.0 mg/dL or 177 µmol/L.
- •International normalized ratio (INR) and activated partial
- •thromboplastin time (aPTT) or partial thromboplastin time (PTT) >1.5 ×
- •ULN (unless on therapeutic coagulation).
- •11. Uncontrolled hypertension (systolic >150 mm Hg and/or
- •diastolic >100 mm Hg) or clinically significant (i.e. active)
- •cardiovascular disease: cerebrovascular accident (CVA)/stroke or
- •myocardial infarction within 6 months prior to first study edication,
- •unstable angina, congestive heart failure (CHF) of New York Heart
- •Association (NYHA) grade II or higher, or serious cardiac arrhythmia
- •requiring medication. 12. Current known infection with HIV, HBV, or HCV.
- •13. Dyspnea at rest due to complications of advanced malignancy, or
- •other disease requiring continuous oxygen therapy.
- •14. Major surgical procedure or significant traumatic injury
- •within 28 days prior to randomization or anticipation of need for major surgery during the course of study treatment.
- •15. Lack of physical integrity of the upper gastrointestinal tract,
- •clinically significant malabsorption syndrome, or inability to take oral medication.
- •16. Receipt of intravenous antibiotics for infection within 14 days prior to randomization.
- •17. Current chronic daily treatment with corticosteroids (dose of 10 mg/day methylprednisolone equivalent), excluding inhaled steroids.
- •18. Known hypersensitivity to any of the study medications or to excipients of recombinant human or humanized antibodies.
- •19. History of receiving any investigational treatment within 28
- •days prior to randomization.
- •20. Concurrent participation in any clinical trial.
研究者
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