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临床试验/CTRI/2025/07/091252
CTRI/2025/07/091252尚未招募3 期

Assessment of pathological complete response rates with the addition of carboplatin to the sequential taxane-anthracycline chemotherapy in patients with non metastatic triple negative breast cancer

Dr Karthik Ambalavana1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2025年8月2日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
48
试验地点
1
主要终点
Pathological Complete Response

研究概览

简要总结

Neoadjuvant chemotherapy is the preferable approach in patients with locally advanced TNBC.Achieving pCR is considered an essential prognostic factor with long term outcomes. It has been seen that in previous studies , addition of carboplatin to the sequential Taxane-anthracycline regimen has been found to improve pCR compared to the routinely used Anthracycline-taxane regimen. But most of these studies have compared weekly administration regimen of platins and taxanes.  In our study we will compare the pathological complete response rates between two arms – In one arm , we will take the historical controls of patients who had received Anthracycline – Taxane chemotherapy from our existing medical records  In the other arm , we will add Carboplatin at AUC 5 given 3 weekly to the sequential Taxane – Anthracycline chemotherapy.. Making the regimen 3 weekly , we will be able to ensure good compliance and adherence of the patient to chemotherapy and also reduce their expenses as most of our patients travel from relatively far places for chemotherapy and importantly seeing to it that there IS NO compromise on response.

研究设计

研究类型
Interventional
分配方式
Na
盲法
None

入排标准

年龄范围
18.00 Year(s) 至 60.00 Year(s)(—)
性别
Female

入选标准

  • Patients with histopathologically diagnosed Triple negative breast carcinoma with Early stage breast cancer ( More than T1c-T3 , N0-N1 , M0) and Locally advanced Breast cancer (T4,N2-N3,M0).
  • Eastern Coperative Oncology group score : 0-
  • Patients who are medically fit for Chemotherapy.
  • Patients giving informed consent.

排除标准

  • Male Breast cancer Patients with Ejection fraction less than 45 percent Patients with upfront metastatic disease.

结局指标

主要结局

Pathological Complete Response

时间窗: After completion of 8 cycles of Neoadjuvant chemotherapy (6 months)

次要结局

未报告次要终点

研究者

发起方
Dr Karthik Ambalavana
申办方类型
Government medical college
责任方
Principal Investigator
主要研究者

KARTHIK AMBALAVANA

MADRAS MEDICAL COLLEGE

研究点 (1)

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