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CTRI Number  CTRI/2025/07/091252 [Registered on: 21/07/2025] Trial Registered Prospectively
Last Modified On: 20/07/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Study to assess if adding Carboplatin before surgery improves Tumor response in Non metastatic TNBC patients . 
Scientific Title of Study   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  
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  KARTHIK AMBALAVANA 
Designation  SENIOR RESIDENT 
Affiliation  MADRAS MEDICAL COLLEGE 
Address  Department of Medical Oncology , Madras Medical College and Rajiv Gandhi Government General Hospital , Poonamallee High Road , Near Park town , Chennai Central , Tamil Nadu-

Chennai
TAMIL NADU
600003
India 
Phone  9740487908  
Fax    
Email  karthikambalavana2000@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr . Kannan Jayaraman, 
Designation  Professor and Head Of Department 
Affiliation  MADRAS MEDICAL COLLEGE & RAJIV GANDHI GOVERNMENT GENERAL HOSPITAL 
Address  Department of Medical Oncology, Madras Medical College and RGGGH, Poonamallee High Road , 3 , Grand Southern Trunk road , Near Park town , Chennai Central Tamil Nadu - 600003

Chennai
TAMIL NADU
600003
India 
Phone  9444143950  
Fax    
Email  drkannanj@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Viji V Julian 
Designation  SENIOR RESIDENT 
Affiliation  MADRAS MEDICAL COLLEGE & RGGGH 
Address  Department of Medical Oncology, Madras Medical College & RGGGH Poonamallee High Road , Near Park town, Chennai Central,

Chennai
TAMIL NADU
600003
India 
Phone  9443244545  
Fax    
Email  vijivjulian@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  Dr Karthik Ambalavana 
Address  Department of Medical Oncology Madras Medical College and RGGGH Poonamallee High Road Near Chennai Central , Park town Chennai Tamil Nadu 600003 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Karthik Ambalavana  MEDICAL COLLEGE AND RAJIV GANDHI GOVERNMENT GENERAL HOSPITAL  Department of Medical Oncology Madras Medical College Poonamallee High road near Park town Near Chennai Central Chennai Tamil Nadu
Chennai
TAMIL NADU 
09740487908

karthikambalavana2000@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethical Committee Madras Medical College  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Adriamycin and cyclophosphomide for 4 cycles followed by Paclitaxel only for 4 cycles  In the control arm , Carboplatin will not be added and the above regimen will be taken as historical control. Duration - 6 months 
Intervention  Paclitaxel and Carboplatin for 4 cycles followed by Adriamycin and cyclophosphomide for 4 cycles  3 weekly carboplatin was added to the Sequential Taxane-anthracycline chemotherapy vs the Routinely used Anthracycline-Taxane chemotherapy as neoadjuvant in patients with Non metastatic Triple negative Breast cancer and the pCR will be assessed. Duration of Intervention - 6 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Female 
Details  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 : 0-1.
Patients who are medically fit for Chemotherapy.
Patients with normal baseline laboratory values.
Patients giving informed consent.
 
 
ExclusionCriteria 
Details  Male Breast cancer
Patients with Ejection fraction less than 45 percent
Patients with upfront metastatic disease.

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Pathological Complete Response  After completion of 8 cycles of Neoadjuvant chemotherapy (6 months) 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   02/08/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

 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.

 
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