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临床试验/CTRI/2012/01/002392
CTRI/2012/01/002392Other2 期

An open label, phase II trial of afatinib with or without vinorelbine forthe treatment of HER2-overexpressing Inflammatory Breast Cancer

Boehringer Ingelheim India Pvt Ltd0 个研究点目标入组 40 人开始时间: 待定最近更新:
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试验速览

阶段
2 期
状态
Other
发起方
入组人数
40
研究概览入排标准研究者记录与标识符相似试验

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. Female patients >=18 years.
  • •2. Investigator-confirmed diagnosis of Inflammatory Breast Cancer defined as a clinico-pathologic entity that is characterized by diffuse erythema and oedema (peau dâ??orange). Pathological findings of dermal lymphatic emboli or palpable mass are supportive but not necessary for diagnosis.
  • •3. Histologically confirmed breast cancer HER2-overexpressing disease (i.e. IHC 3+ or IHC 2+ with FISH/SISH positivity). (The central lab results of any analysis of archived tissue sample are not required to be available to confirm the eligibility of the patient to take part in the study).
  • •4. Presence of locally advanced (in the opinion of the investigator) or metastatic disease.
  • •5. For trastuzumab pre-treated patients, must have failed prior trastuzumab treatment in the investigatorâ??s opinion.
  • •6. Must have biopsiable disease.
  • •7. Must have disease that can be evaluated according to RECIST 1.1.
  • •NOTE: Patients with skin disease only may be included and their disease evaluated as non-target lesion(s) according to RECIST 1.1.
  • •8. Eastern Cooperative Oncology Group (ECOG) score of 0, 1 or 2 (Ref: Appendix 2).
  • •9. Life expectancy of at least six (6) months in the opinion of the investigator.
  • •10. Written informed consent that is consistent with ICH-GCP guidelines and
  • •local legislation.
  • •11. In addition for Part B (afatinib and vinorelbine combination therapy), patients
  • •must have progressed on afatinib monotherapy in Part A.

排除标准

  • •1. Prior treatment with HER2-targeted small molecules or antibodies (other than
  • •trastuzumab which must have been given in the trastuzumab-failure study
  • •population).
  • •2. Requirement for treatment with any of the prohibited concomitant medications
  • •listed in Section 4.2.2 (restrictions).
  • •3. Must not have received prior vinorelbine in any setting.
  • •4. Known pre-existing interstitial lung disease (ILD).
  • •5. Radiotherapy, chemotherapy, hormone therapy, immunotherapy, trastuzumab
  • •or surgery (other than biopsy) within 2 weeks prior to the first dose of afatinib
  • •in Part A. Patients must have recovered from previous lines of treatment in the
  • •investigatorâ??s opinion. Treatment with palliative radiotherapy (short course to
  • •non-target lesions) is allowed.
  • •6. Active brain metastases (defined as stable for less than 4 weeks and/or
  • •symptomatic and/or requiring changes of treatment with anticonvulsants or
  • •steroids and/or leptomeningeal disease).
  • •7. Any other current malignancy or malignancy diagnosed or relapsed within the
  • •past five (5) years (other than non-melanomatous skin cancer and in situ
  • •cervical cancer).
  • •8. Significant or recent acute gastrointestinal disorders with diarrhoea as a major
  • •symptom e.g. Crohns disease, malabsorption or CTC grade >=2 diarrhoea of
  • •any aetiology.
  • •9. History or presence of clinically relevant cardiovascular abnormalities such as
  • •uncontrolled hypertension (in the investigators opinion), congestive heart
  • •failure NYHA classification of 3 or higher, unstable angina or poorly
  • •controlled arrhythmia (in the investigators opinion).
  • •10. Myocardial infarction within 6 months prior to the first dose of afatinib.
  • •11. Cardiac left ventricular function with resting ejection fraction of less than
  • •12. Any other concomitant serious illness or organ system dysfunction which in
  • •the opinion of the investigator would either compromise patient safety or
  • •interfere with the evaluation of the safety of the test drug.
  • •13. Absolute neutrophil count (ANC) 1.5 x 109/L.
  • •14. Platelet count 100 x 109/L for Part A (afatinib monotherapy).
  • •Platelet count 75 x 109/L for Part B (afatinib and vinorelbine combination
  • •15. Calculated Creatinine clearance 60 ml / min (using Cr51-EDTA or
  • •Cockcroft-Gault formula â?? Ref: Appendix 1) or serum creatinine 1.5 times
  • •upper limit of normal (ULN).
  • •16. Bilirubin 1.5 times upper limit of normal.
  • •17. Aspartate amino transferase (AST) or alanine amino transferase (ALT) 2.5
  • •times ULN (if related to liver metastases 5 times ULN).
  • •18. Women of childbearing potential, unwilling to use a medically acceptable
  • •method of contraception during the trial.
  • •Acceptable methods of contraception include:
  • •- Surgical sterilisation (tubal ligation/hysterectomy)
  • •- Hormonal contraception (if applicable) with one barrier method
  • •- Double barrier method. Double barrier method of contraception is defined as
  • •two barrier methods used simultaneously each time the patient has intercourse.
  • •Accepted barrier methods include diaphragm, female condom, cervical cap,
  • •male condom and intra-uterine device (IUD) (female and male condom,
  • •diaphragm and cervical cap must all be used in conjunction wi

研究者

发起方
Boehringer Ingelheim India Pvt Ltd

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