EUCTR2012-002556-17-DE进行中（未招募）1 期
A randomized phase II trial of pertuzumab in combination with trastuzumab with or without chemotherapy, both followed by T-DM1 in case of progression, in patients with HER2-positive metastatic breast cancer - PERNETTA
ICANCER0 个研究点目标入组 208 人开始时间: 2013年12月10日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 208
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
- Female
入选标准
- •Inclusion criteria for first-line therapy:
- •- Histologically confirmed breast cancer with distant metastases
- •1. A biopsy from the primary tumor or a metastasis can be used for diagnosis.
- •2. Patients with non-measurable lesions are eligible.
- •3. Patients with inoperable, locally advanced breast cancer with lymph node metastases other than ipsilateral locoregional (axillary, infraclavicular, parasternal) or other distant metastases are eligible.
- •4. Patients with bone metastases with or without bone targeted therapy (bisphosphonates, denosumab) are eligible.
- •5. Patients with de-novo Stage IV disease are eligible.
- •- HER2-positive tumor according to central pathology testing for HER2
- •1. A formalin-fixed paraffin-embedded (FFPE) biopsy from the primary tumor or a metastasis has to be used for HER2 status determination. If a biopsy is available from a metastasis, the HER2 testing should be performed using the metastasis.
- •2. Fine needle aspiration is not acceptable for HER 2 testing.
- •- Women aged =18 years
- •- WHO performance status 0 to 2 (see Appendix 2)
- •- Left Ventricular Ejection Fraction (LVEF) =50% as determined by either ECHO or MUGA
- •- Adequate organ function, evidenced by the following laboratory results:
- •Neutrophils >1.5x10^9/L, platelets >100x10^9/L, hemoglobin =90g/L, total bilirubin =1.5xULN (unless the patients has documented Gilbert’s disease), AST=3xULN, ALT =3xULN, AP =2.5xULN (except in patients with bone metastases: AP =5xULN), creatinine =1.5xULN
- •inclusion criteria for second-line therapy:
- •- At least one dose of trial therapy in the first-line treatment phase of this trial
- •- Proven disease progression on first-line therapy or radiotherapy of a bone metastasis
- •First new parenchymal CNS metastases only do not count as progression requiring the initiation of second line trial treatment (please see Appendix 1.4, Determination and evaluation of new lesions).
- •Radiotherapy of a single area only for pain control is allowed and will not count as PD.
- •- Adequate organ function, evidenced by the following laboratory results:
- •Neutrophils >1.5x10^9/L, platelets >100x10^9/L, hemoglobin =90g/L, total bilirubin =1.5xULN (unless the patients has documented Gilbert’s disease), AST =3xULN, ALT =3xULN, AP =2.5xULN (except in patients with bone metastases: AP =5xULN), creatinine =1.5ULN
- •- LVEF =50% as determined by either ECHO or MUGA
- •- QoL questionnaire has been completed.
- •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 104
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 104
排除标准
- •Exclusion criteria for first-line therapy
- •- Prior chemotherapy for inoperable locally advanced or metastatic breast cancer
- •Prior neoadjuvant/adjuvant chemotherapy is allowed if doses for anthracylines have not exceeded 720mg/m2 and 240mg/m2 for epirubicin and doxorubicin, respectively.
- •- Reexposure to paclitaxel is permitted, if the last dose of taxane was given at least 1 year before randomisation.
- •- Reexposure to vinorelbine is permitted, if the last dose of vinorelbine was given at least 1 year before randomisation.
- •- Prior anti-HER2 treatment for metastatic or inoperable breast cancer
- •Prior neoadjuvant/adjuvant anti-HER2 treatment with trastuzumab and/or lapatinib is allowed.
- •- More than one endocrine treatment line for metastatic or inoperable breast cancer exceeding a duration of 1 month
- •1. Adjuvant endocrine treatment is not counted as one line.
- •2. Patients progressing on endocrine treatment: this specific endocrine endocrine treatment must have been stopped at least 2 weeks prior to randomization.
- •- Prior treatment with pertuzumab and/or T-DM1
- •- Known leptomeningeal or CNS metastases
- •A brain MRI or CT scan is mandatory in case of clinical suspicion of CNS metastases.
- •- Single bone metastasis treated with radiotherapy (if the bone metastasis is the only tumor lesion)
- •Exclusion criteria for second line therapy:
- •- Termination of first-line therapy with trastuzumab/pertuzumab due to unacceptable toxicity without objective evidence of disease progression
- •- CNS metastases that are untreated, symptomatic, or require therapy to control symptoms, as well as a history of radiation, surgery, or other therapy, including steroids, to control symptoms from CNS metastases within 2 months (60 days) before registration
- •- Peripheral neuropathy of CTCAE grade =3
- •- Interstitial lung disease (ILD) or pneumonitis grade =4
- •- Any other adverse event which has not recovered to CTCAE grade =1 (except alopecia)
研究者
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