| 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
|
|
|
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
|
|
|
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
|
|
|
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. |