EUCTR2008-003283-20-FR进行中（未招募）不适用
A single arm, open-label, phase II study of bevacizumab in combination with trastuzumab and capecitabine as first-line treatment of 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
- 88
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. Age = 18 years.
- •2. Histologically or cytologically confirmed breast adenocarcinoma with measurable
- •(per RECIST), locally recurrent or metastatic lesions.
- •3. Candidates for chemotherapy. Locally advanced disease must not be amenable to
- •resection with curative intent.
- •4. Documented HER2 positive disease (HER2 overexpression indicated by IHC 3+
- •and/or FISH + and/or chromogenic in situ hybridization (CISH) + of the primary
- •tumor or a metastasis).
- •5. Documented ER/PgR status (positive or negative).
- •6. ECOG Performance Status = 2.
- •7. Able and willing to comply with the protocol.
- •8. Written and signed informed consent prior to beginning study-specific procedures
- •showing the patient’s awareness and willingness to participate in the trial and
- •comply with its proceedings and with the understanding that the patient has the
- •right to withdraw from the study at any time without prejudice. (Note: the
- •informed consent document must be approved by the institution’s Independent
- •Ethics Committee).
- •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 treatment for locally advanced or mBC other than hormone therapy or
- •radiotherapy. Anti-epidermal growth factor receptor or anti-HER2 agents or
- •vaccines and cytotoxic chemotherapies for locally recurrent or mBC are not
- •allowed. Patients must have fully recovered from side effects of any prior
- •radiotherapy.
- •2. Any prior neoadjuvant or adjuvant treatment with anthracyclines completed less
- •than 6 months prior to enrolment. The max. cumulative dose received must not
- •have exceeded 360 mg/sqm for doxorubicin or 720 mg/sqm for epirubicin.
- •3. Chronic daily treatment with corticosteroids and/or with aspirin or clopidogrel.
- •4. Requirement for concurrent use of the antiviral agent sorivudine, or chemically
- •related analogues, such as brivudine.
- •5. Minor surgical procedures, within 24 hours prior to enrolment.
- •6. Current or recent (within the 30 days prior to starting study treatment)
- •treatment with another investigational drug or participation in another
- •investigational study.
- •7. Inadequate bone marrow function, liver function and or renal function
- •8. Patients not receiving anticoagulant medication who have an International
- •Normalized Ratio (INR) > 1.5 or an activated partial thromboplastin time (aPTT) >
- •1.5 x ULN within 7 days prior to enrolment.
- •Note: Patients receiving full dose oral or parenteral anticoagulants may be included as long as anticoagulant dosing has been stable for at least two weeks prior to study entry and the appropriate coagulation monitoring tests are within therapeutic limits.
- •9. Other primary malignancy (including primary brain tumors) within the last 5 years
- •prior to enrolment, except for adequately treated carcinoma in situ of the cervix,
- •squamous carcinoma of the skin, or adequately controlled limited basal cell skin
- •10. Dyspnea at rest due to complications of advanced malignancy (e.g. pulmonary
- •metastases with lymphangitis) or any condition necessitating supportive oxygen
- •11. Evidence of CNS metastasis.
- •12. Evidence of spinal cord compression caused by metastases.
- •13. History or evidence upon physical/neurological examination of CNS disease
- •unrelated to cancer (e.g. uncontrolled seizures) unless adequately treated with
- •standard medical therapy.
- •14. Major surgical procedure, open biopsy or significant traumatic injury within 28
- •days prior to enrolment, or anticipation of the need for major surgery during the
- •course of the study treatment.
- •15. Uncontrolled hypertension (systolic > 150 mm Hg and/or diastolic > 100 mm Hg)
- •or clinically significant (i.e. active) cardiovascular disease
- •16. Baseline LVEF < 50% measured by either echocardiography or MUGA.
- •17. History or evidence of inherited bleeding diathesis or coagulopathy with the risk
- •of bleeding.
- •18. History of abdominal fistula, gastrointestinal perforation, or intra-abdominal
- •abscess within 6 months of enrolment.
- •19. Active infection requiring IV antibiotics at enrolment.
- •20. Serious non-healing wound, peptic ulcer, or bone fracture.
- •21. Clinically significant malabsorption syndrome, or inability to take oral medication.
- •22. 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 inve
研究者
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