CTRI/2021/09/036766已完成2 期
A Prospective, randomized, open label, study to determine the safety and efficacy of Group- I - AB001 Alone, Group – II – AB001 + Chemotherapy and Group – III – Chemotherapy Alone in patients with Triple Negative Breast Cancer(TNBC) and KRAS mutated Cancer.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Clinical Benefit Rate Complete Response (CR) with Partial Response (PR) with Stable Disease (SD) Tumor Reduction Time Frame Up to3months
研究概览
简要总结
This is an Academic P.I based study to a Prospective, randomized, open label, study to determine the safety and efficacy of Group- I - AB001 Alone, Group – II – AB001 + Chemotherapy and Group – III – Chemotherapy Alone in patients with Triple Negative Breast Cancer(TNBC) and KRAS mutated Cancer and to evaluate the antitumor activity of single-agent AB001measured by overall response rate (ORR) [ Time Frame: up to 3 months] as assessed by the best tumor response (complete response [CR] partial response [PR], stable disease, and progressive disease) during the study using Response Evaluation Criteria in Solid Tumors .
The study was completed with 04 Randomized subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age–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.
- •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.
排除标准
- •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.
结局指标
主要结局
Clinical Benefit Rate Complete Response (CR) with Partial Response (PR) with Stable Disease (SD) Tumor Reduction Time Frame Up to3months
时间窗: baseline, 4 weeks and 8 weeks
次要结局
- Best Overall Response (OR) Time Frame Up to3months(Duration of Overall Response Time Frame Up to 3 months)
研究者
研究点 (1)
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