EUCTR2011-002132-10-GB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 combination with trastuzumab plus an aromatase inhibitor in first line patients with HER2-positive and hormone receptor-positive advanced (metastatic or locally advanced) breast cancer. - PERTAI
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
- 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 (fulfilling one or more of
- •National Comprehensive Cancer Network [NCCN] guideline
- •criteria, Version 1.2016).
- •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
- •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:
- •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. Patients with radiographic evidence of central nervous system (CNS) metastases as assessed by CT or MRI that are not well controlled (symptomatic or requiring control with continuous corticosteroid therapy (eg dexamethasone)). Note: Patients with CNS metastases are permitted to participate in the study if they are medically well controlled prior to screening (as assessed by the investigator) after receiving local therapy (irradiation, surgery etc) but without anti-HER2 therapy.
- •7. Current peripheral neuropathy of grade 3 or higher (NCI-CTC, Version 4.0).
- •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
- •14. Major surgical procedure or significant traumatic injury
- •within 14 days prior to randomization or anticipation of need
- •for major surgery during the course of study treatment. Note: Should surgery be necessary during the course of the study, patients should be allowed to recover for a minimum of 14 days prior to subsequent pertuzumab and trastuzumab treatment.
- •15. Lack of physical integrity of the upper gastrointestinal tract,
- •clinically significant malabsorption syndrome, or inability to
- •take oral medication.
- •16. Receipt of intrav
研究者
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