A Prospective, randomized, open label, study to determine the safety and efficacy of Group- I - AB001 Alone, Group Ã¢â?¬â?? II Ã¢â?¬â?? AB001 + Chemotherapy and Group Ã¢â?¬â?? III Ã¢â?¬â?? Chemotherapy Alone in patients with Triple Negative Breast Cancer(TNBC) and KRAS mutated Cancer. - NA

Agastiya Biotech LLC0 个研究点目标入组 4 人开始时间: 待定最近更新: 2022年10月17日

试验速览

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•1.AgeÃ¢â?¬â??18 to70 years(female)
•2.Patients with advanced Triple Negative Breast Cancer (TNBC) and KRAS mutated Cancer by testing (HER2, ER, PR and KRAS expression), not amenable to surgical therapy.
•3.Eligible for taxane monotherapy.
•4.No prior chemotherapy or targeted systemic therapy (including endocrine therapy) for inoperable locally advanced or metastatic breast Cancer (TNBC).
•5.Patients must have measurable disease on radiological imaging PET scan to monitor treatment response. Measurable disease, as defined by RECISTv1.1.
•6.Women of child bearing potential must agree to either use a contraceptive method or to remain abstinent during the treatment period and for at least 5 months after the last dose of study drug, or for at least 6 months after the last dose of paclitaxel.
•7.Life expectancy > 24 weeks
•8.Patient should be willing to undergo all treatment related procedures and investigations
•9.PatientshouldbewillingandreadyforPETScanand/orCTand/orUSGand/orMRIand follow-up scans
•10.Patient is willing to take and to tolerate cytotoxic drugs
•Willing to sign informed consent form

•1.Patients above 70yr sage
•2.Pregnant or lactating women, or intending to become pregnant during the study.
•3.Life threatening comorbidities suchas HIV, HPV, HBV, HCV, Tuberculosis ,CHF, Impaired Hepaticor Renal Function oranypsychological deficits etc.
•4.Known CNS disease, except for treated asymptomatic CNS metastases.
•5.Uncontrolled pleural effusion, pericardial effusion, orascites
•6.Uncontrolled tumor-related pain
•7.Significant cardiovascular disease, such as New York Heart As Standard of Careiation (NYHA) cardiac disease (Class II or greater), MI within 3 months prior to randomization, unstable arrhythmias, or unstable angina.
•8.Major surgical procedure within 4weeks prior to randomization or anticipation of the need for a major surgical procedure during the study other than for diagnosis.
•9.History of autoimmune disease.
•10.Prior allogeneic stem cell or solid organ transplantation
•11.Poor peripheral venous access
•Patients not suitable for study as per investigators opinion.

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