EUCTR2006-000564-81-DE进行中（未招募）1 期
A randomised, multicentre, open-label, phase III study of neoadjuvant lapatinib, trastuzumab, and their combination plus paclitaxel in women with HER2/ErbB2 positive primary breast cancer - NeoALTTO
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
- 450
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
- •2) Age =18 years
- •3) Performance Status- Eastern Cooperative Oncology Group (ECOG) 0-1
- •4) Histologically confirmed invasive breast cancer:
- •- Primary tumour greater than 2 cm diameter,
- •- Any Node,
- •- No evidence of metastasis (M0) (isolated supraclavicular node involvement allowed)
- •5) Over expression and/or gene amplification of ErbB2 in the invasive component of the primary tumour according to one of the following definitions and confirmed by a certified laboratory prior to randomisation:
- •– 3+ over expression by IHC;
- •– 2+ or 3+ (in 30% or less neoplastic cells) over expression by IHC AND in situ hybridization (FISH/CISH) test demonstrating HER2 gene amplification;
- •– HER2 gene amplification by FISH/CISH
- •Patients with a negative or equivocal overall result and staining scores of 0, 1+, 2+ or 3+ (in 30% or less neoplastic cells) by IHC are not eligible
- •Equivocal local results from non certified laboratories may be submitted for a final determination by the certified laboratory.
- •ErbB2 status must be tested in local or regional certified laboratories prior to randomisation. Local testing performed in non-certified laboratories, will also need confirmation of the results by a certified laboratory.
- •6) Hormone receptor (HR) status:
- •- Oestrogen Receptor (ER) status must be known.
- •7) Haematopoietic status:
- •- Absolute neutrophil count =1.5 x 10^9/L,
- •- Platelet count =100 x 10^9/L,
- •- Hemoglobin at least 9 g/dl,
- •8) Hepatic status:
- •- Bilirubin = 2 x upper limit of normal (ULN),
- •- AST and ALT = 2.5 times ULN,
- •- Alkaline phosphatase = 2.5 times ULN,
- •9) Renal status:
- •- Creatinine = 2.0 mg/dL,
- •0) Cardiovascular:
- •- Baseline LVEF = 50% measured by echocardiography (ECHO) or Multiple Gate Acquisition (MUGA) scan,
- •11) Negative serum pregnancy test, within 2-weeks (preferably 7 days) prior to randomization (For women of childbearing potential)
- •12) Fertile patients must use effective contraception as specified in the protocol
- •13) Signed informed consent form (ICF)
- •14) Patient accepts to make available tumour samples for submission to central laboratory to conduct translational studies as part of this protocol
- •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 403
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 52
排除标准
- •1) Received any prior treatment for primary invasive breast cancer;
- •2) History of other malignancy. However, subjects with a past or current history of completely resected basal and squamous cell carcinoma of the skin or successfully treated in situ carcinoma of the cervix are eligible;
- •3) Diagnosis of inflammatory breast cancer;
- •4) Bilateral cancer;
- •5) Multi-focal cancer;
- •6) Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, uncontrolled hypertension (= 180/110), unstable diabetes mellitus, dyspnoea at rest, or chronic therapy with oxygen;
- •7) Concurrent disease or condition that would make the subject inappropriate for study participation or any serious medical disorder that would interfere with the subject’s safety;
- •8) Unresolved or unstable, serious adverse events from prior administration of another investigational drug;
- •9) Active or uncontrolled infection;
- •10) Dementia, altered mental status, or any psychiatric condition that would prevent the understanding or rendering of ICF;
- •11) Malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Subjects with ulcerative colitis are also excluded;
- •12) Concurrent neoadjuvant cancer therapy (chemotherapy, radiation therapy, immunotherapy, biologic therapy other than the trial therapies);
- •13) Concurrent treatment with an investigational agent or participation in another therapeutic clinical trial;
- •14) Known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to trastuzumab or lapatinib or their excipients;
- •15) Pregnant or lactating women;
- •16) Concomitant use of CYP3A4 inhibitors or inducers.
研究者
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