EUCTR2011-005334-20-GR进行中（未招募）1 期
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancer - PERUSE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,500
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
入选标准
- •1. Signed written informed consent approved by the relevant Institutional Review Board (IRB), or Independent Ethics Committee (IEC).
- •2. Male or female patients aged 18 years or over.
- •3. Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection.
- •4. HER2-positive (defined as either IHC 3+ or in situ hybridization [ISH] positive) as assessed by local laboratory on primary tumor and/or metastatic site if primary tumor not available (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).
- •5. At least one measurable lesion and/or non-measurable disease evaluable according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 (Appendix 5).
- •6. Eastern Cooperative Oncology Group (ECOG) performance status 0, 1 or 2 (Appendix 3).
- •7. LVEF of at least 50%.
- •8. Negative serum pregnancy test in women of childbearing potential (WOCBP; premenopausal or less than 12 months of amenorrhea post-menopause, and who have not undergone surgical sterilization).
- •9. For WOCBP and male patients with partners of CBP who are sexually active, agreement to use a highly effective, non-hormonal form of contraception (such as surgical sterilization) or two effective forms of non-hormonal contraception (such as a barrier method of contraception in conjunction with spermicidal jelly) during and for at least 6 months post-study treatment (refer to Section 4.5.2.1 for details).
- •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 1260
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 240
排除标准
- •1. Previous systemic non-hormonal anticancer therapy for the metastatic or locally recurrent disease.
- •2. Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence within 6 months.
- •3. Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting.
- •4. Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting.
- •5. History of persistent Grade 2 or higher (National Cancer Institute [NCI]-Common Toxicity Criteria [CTC], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy.
- •6. Radiographic evidence of central nervous system (CNS) metastases as assessed by computed tomography (CT) or magnetic resonance imaging (MRI).
- •7. Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, Version 4.0).
- •8. History of other malignancy within the last 5 years prior to 1st study drug administration (dosing), 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 treatment-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)
- •Aspartate aminotransferase (AST [SGOT]) or alanine aminotransferase (ALT [SGPT]) >2.5 × ULN (> 5 × ULN in patients with liver metastases)
- •Alkaline phosphatase levels > 2.5 × the ULN (> 5 × ULN in patients with liver metastases, or >10 × ULN in patients with bone metastases)
- •Serum creatinine >2.0 mg/dL or 177 µmol/L
- •International normalized ratio (INR) and activated partial thromboplastin time or partial thromboplastin time (aPTT or PTT) >1.5 × ULN (unless on therapeutic anti-coagulation).
- •11. Uncontrolled hypertension (systolic >150 m m Hg and/or
- •diastolic >100 mm Hg) or clinically significant (i.e. active) cardiovascular disease: cerebrovascular accident/stroke or myocardial infarction within 6 months prior to first study medication, 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, Hepatitis B virus, or Hepatitis C virus.
- •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 1st study drug administration (dosing) or anticipation of need for major surgery during the course of study treatment.
- •15. Receipt of intravenous antibiotics for infection within 14 days prior to enrolment.
- •16. Current chronic daily treatment with corticosteroids (dose e
研究者
相似试验
进行中（未招募）
1 期
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancerAdvanced breast cancer (metastatic or locally recurrent)MedDRA version: 20.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-005334-20-SEF. Hoffmann-La Roche Ltd.1,500
进行中（未招募）
1 期
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancerAdvanced breast cancer (metastatic or locally recurrent)MedDRA version: 20.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-005334-20-EEF. Hoffmann-La Roche Ltd.1,500
进行中（未招募）
1 期
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancerEUCTR2011-005334-20-ESF. Hoffmann-La Roche Ltd.1,500
进行中（未招募）
1 期
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancerAdvanced breast cancer (metastatic or locally recurrent)MedDRA version: 19.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-005334-20-HUF. Hoffmann-La Roche Ltd.1,500
进行中（未招募）
1 期
A multicenter, open-label, single-arm study of pertuzumab in combination with trastuzumab and a taxane in first line treatment of patients with HER2- positive advanced (metastatic or locally recurrent) breast cancerAdvanced breast cancer (metastatic or locally recurrent)MedDRA version: 20.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2011-005334-20-ATF. Hoffmann-La Roche Ltd.1,500