A MULTICENTER, MULTINATIONAL, RANDOMIZED, DOUBLE-BLIND, PHASE III STUDY OF IMC-1121B PLUS DOCETAXEL VERSUS PLACEBO PLUS DOCETAXEL IN PREVIOUSLY UNTREATED PATIENTS WITH HER2-NEGATIVE, UNRESECTABLE, LOCALLY-RECURRENT OR METASTATIC BREAST CANCER

ImClone LLC,0 个研究点目标入组 16 人开始时间: 2010年8月31日最近更新: 2023年9月4日

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•1)Participant is able to provide signed informed consent
•2)Participant is female and ≥ 18 years of age or older if required by local laws or regulations
•3)Participant has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent. Every effort should be made to make paraffin-embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis
•4)Participant has measurable and/or non-measurable disease
•5)Participants´ primary and/or metastatic tumor is human epidermal growth factor receptor 2 (HER2)-negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC)
•6)Participant completed (neo) adjuvant taxane therapy at least 6 months prior to randomization

•1)Participant has a concurrent active malignancy other than breast adenocarcinoma, adequately treated non melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. A participant with previous history of malignancy is eligible, provided that she has been disease free for > 3 years.
•2)Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80.
•3)Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80.
•4)Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80.
•5)Participant has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (such as, pelvic or abdominal radiation) within 30 days prior to randomization

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