A Prospective, adaptive, randomized, open-Label, multicenter Clinical Trial to assess the efficacy and safety of Fixed Dose Combination of Capecitabine & Cyclophosphamide in patients of Metastatic Breast Cancer with failure of Anthracycline and/or taxane chemotherapy - NA

Intas Pharmaceuticals Ltd0 个研究点目标入组 166 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.The patient willing to give written, signed and dated, informed consent to participate in the study.
•2.Female >=18 years and <=65 years of age.
•3.Patient must have histopathologically / cytologically confirmed breast cancer.
•4.Have at least one measurable lesion as per the RECIST criteria (version 1.1)
•5.Eastern Cooperative Oncology Group (ECOG) performance status <= 2
•6.Left Ventricular Ejection fraction (LVEF) >= 50% as per Echocardiography (ECHO).
•7.Patient must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator.
•8.Previous chemotherapy/radiotherapy should be completed 4 weeks prior to start of IMP administration
•9.Patients with life expectancy of at least 6 months.
•10.Serum pregnancy test at screening visit and urine pregnancy test at baseline visit must be negative and agreed to use birth control measured throughout study duration.
•11.Patient with adequate bone marrow, renal and hepatic function.

•1.Patients with known hypersensitivity to capecitabinecyclophosphamide, any excipients of IMPs or with known DPD deficiency.
•2.Concurrent chemotherapy or radiation therapy regimens.
•3.Patient with clinically significant cardiac conditions:
•4.Known History of drug addiction within last 1 year
•5.Any other condition that, in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study.
•6.Patients who are unwilling or unable to follow protocol requirements.

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