PER-012-18尚未招募未知
A PHASE III, RANDOMIZED, MULTICENTER, OPEN-LABEL, TWO-ARM STUDY TO EVALUATE THE PHARMACOKINETICS, EFFICACY, AND SAFETY OF SUBCUTANEOUS ADMINISTRATION OF THE FIXED-DOSE COMBINATION OFPERTUZUMAB AND TRASTUZUMAB IN COMBINATION WITH CHEMOTHERAPY IN PATIENTS WITH HER2-POSITIVE EARLY BREAST CANCER
F. Hoffmann- La Roche, Ltd /Genentech Inc,0 个研究点目标入组 0 人开始时间: 2018年8月7日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 发起方
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
- •Signed Informed Consent Form
- •Age 18 years
- •Female and male patients with Stage II IIIC (T2T4, N0N3, M0), locally advanced,
- •inflammatory, or early-stage, unilateral, and histologically confirmed invasive breast cancer
- •Patients with inflammatory breast cancer must be able to have a core-needle biopsy
- •Primary tumor 2 cm in diameter, or node-positive (clinically, on imaging, and on
- •cytology/histopathology)
- •HER2-positive breast cancer confirmed by a central
- •Hormone receptor status of the primary tumor confirmed
- •Patient agreement to undergo mastectomy or breast conserving surgery after neoadjuvant
- •Availability of formalin-fixed, paraffin-embedded (FFPE) tumor tissue block for central
- •confirmation of HER2 and hormone receptor status and additional biomarker research (e.g.,
- •PIK3A mutational analyses)
- •Baseline LVEF 55% measured by echocardiogram (ECHO) or multiple-gated acquisition
- •scan (MUGA)
- •For women of childbearing potential (WOCBP) who are sexually active: agreement to
- •remain abstinent (refrain from heterosexual intercourse) or use one highly effective nonhormonal
- •contraceptive method.
- •For men: agreement to remain abstinent (refrain from heterosexual intercourse) or use one highly effective nonhormonal contraceptive method, and agreement to refrain from donating sperm.
- •A negative serum pregnancy test must be available prior to randomization.
排除标准
- •Stage IV (metastatic) breast cancer
- •Patients with a history of invasive breast cancer
- •Patients with a history of concurrent or previously treated non-breast malignancies except for
- •appropriately treated 1) non-melanoma skin cancer and/or 2) in situ carcinomas, including
- •cervix, colon, and skin
- •Patients who have received any previous systemic therapy (including chemotherapy,
- •immunotherapy, HER2-targeted agents, endocrine therapy (selective estrogen receptor
- •modulators, aromatase inhibitors, and antitumor vaccines) for treatment or prevention of
- •breast cancer, or radiation therapy for treatment of cancer
- •Patients who have a past history of ductal carcinoma in situ (DCIS) or lobular carcinoma in
- •situ (LCIS) if they have received any systemic therapy for its treatment or radiation therapy
- •to the ipsilateral breast
- •Patients are allowed to enter the study if treated with surgery alone.
- •Patients with high-risk for breast cancer who have received chemopreventative drugs in the
- •past are not allowed to enter the study
- •Patients with multicentric (multiple tumors involving more than one quadrant) breast cancer,
- •unless all tumors are HER2-positive
- •Patients with bilateral breast cancer
- •Patients who have undergone an excisional biopsy of primary tumor and/or axillary lymph
- •Axillary lymph node dissection (ALND) prior to initiation of neoadjuvant therapy
- •Patients with clinically negative axilla (by physical examination and radiographic
- •imaging) may undergo a core or needle biopsy procedure prior to neoadjuvant systemic
- •therapy if in keeping with local practice
- •Sentinel lymph node biopsy (SLNB) prior to neoadjuvant therapy
- •Treatment with any investigational drug within 28 days prior to randomization
- •Serious cardiac illness or medical conditions
- •Inadequate bone marrow function
- •Impaired liver function
- •Inadequate renal function with serum creatinine 1.5 ULN
- •For more details consult the protocol.
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