CTRI/2012/08/002900已完成2 期
A randomized, two-arm, open-label, multicenter Phase II trial assessing 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.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Signed written informed consent approved by
- •the relevant 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; Appendix 7).
- •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 estrogen
- •receptor (ER)-positive and/or progesterone
- •receptor (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. Eastern Cooperative Oncology Group (ECOG)
- •performance status 0 or 1.
- •9. LVEF of at least 50%.
- •10.Life expectancy of at least 12 weeks.
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
- •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
- •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
- •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
- •treatment related complications.
- •10. Inadequate organ function, evidenced by the
- •following laboratory results:
- •a) Absolute neutrophil count 1,500 cells/mm3.
- •b) Platelet count 100,000 cells/mm3.
- •c) Hemoglobin 9 g/dL.
- •Total bilirubin greater than the upper limit
- •of normal (ULN) (unless the patient has
- •documented Gilbertâ??s syndrome).
- •AST (SGOT) or ALT (SGPT) 2.5 Ã? ULN.
- •AST (SGOT) or ALT (SGPT) 1.5 Ã? ULN with
- •concurrent serum alkaline phosphatase 2.5 Ã?
- •ULN Serum alkaline phosphatase may be 2.5 Ã?
- •ULN only if bone metastases are present and
- •AST (SGOT) and ALT (SGPT) 1.5 Ã? 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 Ã?
- •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
- 另有 16 项未显示
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