An early phase II study of TSU-68 in combination with docetaxel in patients with advanced and metastatic breast cancer progressing anthracycline containing regimen.

Taiho Pharmaceutical Co., Ltd.0 个研究点目标入组 19 人开始时间: 2010年7月1日最近更新: 2023年10月17日

适应症

试验速览

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•1) A patient who herself agreed in writing to become a study subject for this clinical study.
•2) A patient at the age of not less than 20 years and not more than 75 years.
•3) A woman who was histologically or cytologically diagnosed as breast cancer.
•4) A patient whose measurable lesion was identified by the objective data.
•5) A patient who has at least one lesion which satisfied the criteria based on the data within 30 days before start of this clinical study.
•6) A patient who was judged irresponsive to anthracycline drugs.
•7) A patient who has not been treated with a taxane drug.
•8) A patient with physiologically well maintained compensatory functions, especially the function of parenchymal organs including bone marrow, liver, kidney and heart.
•9) A patient who can receive oral administration.
•10) A patient who is expected to live for sufficient period of time.
•11) A patient whose WHO's performance status (P.S.) is 0-2.

•1) A patient who was affected by pretreatment.
•2) A patient with a large amount of pleural effusion, ascites or pericardial fluid that requires drainage to remove the fluid or affects respiratory or circulatory kinetics.
•3) A patient who has cerebral lesion with clinical symptoms.
•4) A patient who has active infection.
•5) A patient who has serious complication.
•6) A patient who has the experience of serious thrombosis.
•7) A patient who has the experience of serious anaphylaxis to the polysorbate 80-containing preparation.
•8) A patient who routinely requires oral or intravenous steroids.
•9) A patient who has colon disorder with active inflammation.
•10) A woman who wishes a baby, pregnant woman and a woman in a lactation period.

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