EUCTR2006-001365-42-CZ进行中（未招募）不适用
A randomized, open-label, 2-arm, multicentre, phase III study to evaluate the efficacy and safety of bevacizumab in combination with trastuzumab / docetaxel compared with trastuzumab / docetaxel alone as first line treatment for patients with HER2 positive locally recurrent or metastatic breast cancer.
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 410
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
- All
入选标准
- •1. Patients age = 18 years
- •2. Able to comply with the protocol
- •3. ECOG PS of = 1
- •4. Life expectancy of = 12 weeks
- •5. Written informed consent [Informed Consent document to be approved by the
- •institution’s Independent Ethics Committee (IEC)] obtained prior to any study
- •specific screening activities.
- •6. Pre- or postmenopausal patients with histologically or cytologically confirmed
- •breast cancer (adenocarcinoma) with measurable or non-measurable, locally
- •recurrent or metastatic lesions, candidate for chemotherapy. Locally recurrent
- •disease must not be amenable to resection with curative intent ER/PgR and HER2
- •status must be documented.
- •7. Patients must have HER2 protein overexpression (3+) as determined by
- •immunohistochemistry (IHC); or amplification of HER2/c-erbB2 as determined by
- •fluorescent in situ hybridization (FISH) or chromogenic in situ hybridization (CISH) ,
- •of the primary tumor or a metastasis confirmed by the central laboratory prior to
- •randomization. Confirmation of HER2 positivity of the primary tumor by the central
- •laboratory is not required in this trial for the patients who previously participated
- •in Roche or Genentech sponsored trials of adjuvant Trastuzumab where HER2
- •status has been centrally confirmed (e.g. the HERA, BCIRG 006, NSABP B31, or
- •Intergroup/NCCTG/H2061s trials).
- •8. Patients who received trastuzumab in the adjuvant setting are eligible as long as
- •they have not relapsed within 6 months after the last dose of trastuzumab.
- •9. Patients who were treated with anthracyclines in adjuvant or neo-adjuvant
- •setting are only eligible if they received their last dose = 6 months prior to
- •randomization. The maximum cumulative dose must not exceed 360 mg/m2 for
- •doxorubicin and 720 mg/m2 for epirubicin
- •10. Patients who were treated with a taxane are only eligible if they received their
- •last adjuvant or neo-adjuvant chemotherapy = 12 months prior to
- •randomization. 11. Baseline Left Ventricular Ejection Fraction (LVEF) not below
- •50% measured by either echocardiography or MUGA
- •12. The use of full-dose oral or parenteral anticoagulants is permitted as long as the
- •patient has been on a stable level of anticoagulation for at least two weeks at
- •the time of randomization:
- •– Patients on heparin treatment should have a baseline aPTT between 1.5 - 2.5
- •times ULN or patients value before starting heparin treatment
- •– Patients on low molecular weight heparins (LMWH) should receive daily dose of
- •1.5 - 2 mg/kg (of enoxaparin) or appropriate doses of the correspondent
- •anticoagulant, according to package insert
- •– Patients on coumarin derivatives should have an INR between 2.0 and 3.0
- •assessed at baseline in two consecutive measurements 1-4 days apart
- •Patients not receiving anticoagulant medication must have an INR = 1.5 and aPTT = 1.5 times ULN within 7 days prior to randomization.
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous chemotherapy for metastatic or locally recurrent breast cancer. Prior
- •hormonal therapy is allowed but must have been discontinued at least 2 weeks
- •prior randomization.
- •2. Previous radiotherapy for treatment of metastatic breast cancer is not allowed in
- •- More than 30% of marrow-bearing bone have been irradiated
- •- The last fraction of radiotherapy has been administered within 3 weeks prior to
- •randomization
- •Prior adjuvant radiotherapy for breast cancer is allowed, provided it has stopped at least 6 months prior to randomization.
- •3. Other primary tumor (including primary brain tumors) within the last 5 years prior
- •to randomization, except for adequately treated carcinoma in situ of the cervix,
- •squamous carcinoma of the skin, or adequately controlled limited basal cell skin
- •4. Evidence of spinal cord compression or current evidence of CNS metastasis. CT or
- •MRI scan of the brain is mandatory (within 4 weeks prior to randomization) in
- •case of clinical suspicion of brain metastasis.
- •5. History or evidence upon physical/neurological examination of CNS disease
- •(unrelated to cancer) (unless adequately treated with standard medical therapy)
- •e.g. uncontrolled seizures
- •6. Major surgical procedure, open biopsy or significant traumatic injury within 28
- •days prior to study treatment start, or anticipation of the need for major surgery
- •during the course of the study treatment
- •7. Existing peripheral neuropathy > CTC Grade 2 at randomization.
- •8. Inadequate bone marrow function: ANC < 1.5 x 1'000'000'000/L, Platelet count <
- •100 x 1'000'000'000/L and Hb <9 g/dL
- •9. Inadequate liver function:
- •- serum (total) bilirubin > ULN
- •- AST and ALT > 2.5 x ULN
- •- AST or ALT > 1.5 x ULN concurrent with serum alkaline phosphatase levels
- •> 2.5 x ULN at baseline
- •10. Inadequate renal function:
- •i. Serum Creatinine > 2.0 mg/dL or 177 µmol/L
- •ii. Urine dipstick for proteinuria > 2+. Patients with = 2+ proteinuria on dipstick
- •urinalysis at baseline should undergo 24 hours urine collection and must
- •demonstrate = 1 g of protein/24 hr.
- •11. Chronic daily treatment with corticosteroids (dose of > 10 mg/day
- •methylprednisolone equivalent) (excluding inhaled steroids).
- •12. Chronic daily treatment with aspirin (> 325 mg / day) or clopidogrel (> 75 mg /
- •13. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg)
- •or clinically significant (i.e. active) cardiovascular disease: CVA/stroke (= 6
- •months prior to randomization), myocardial infarction (= 6 months prior to
- •randomization), unstable angina, New York Heart Association (NYHA) Class 2 or
- •greater Congestive Heart Failure, or serious cardiac arrhythmia requiring
- •14. History or evidence of inherited bleeding diathesis or coagulopathy with the risk
- •of bleeding
- •15. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
- •abscess within 6 months of randomization.
- •16. Active infection requiring i.v. antibiotics at randomization.
- •17. Serious non-healing wound, peptic ulcer, or bone fracture.
- •18. Evidence of any other disease, metabolic or psychological dysfunction, physical
- •examination finding, or clinical laboratory finding giving reasonable suspicion of a
- •disease or condition that contraindicates the use of an investigational drug, or
- 另有 1 项未显示
研究者
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