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CTRI Number  CTRI/2022/06/043109 [Registered on: 09/06/2022] Trial Registered Prospectively
Last Modified On: 08/06/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Diagnostic 
Study Design  Other 
Public Title of Study   Evaluation of biomolecules to know cancer response in breast cancer patients 
Scientific Title of Study   Assessment of prognostic biomarkers to predict pathological complete response in patients with non-metastatic triple-negative breast cancer using a window of opportunity design 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Biswajit Dubashi 
Designation  Professor 
Affiliation  JIPMER, Puducherry 
Address  Department of Medical Oncology, JIPMER, Puducherry,605001, India.

Pondicherry
PONDICHERRY
605001
India 
Phone  8056338405  
Fax    
Email  drbiswajitdm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Biswajit Dubashi 
Designation  Professor 
Affiliation  JIPMER, Puducherry 
Address  Department of Medical Oncology, JIPMER, Puducherry, India.

Pondicherry
PONDICHERRY
605001
India 
Phone  8056338405  
Fax    
Email  drbiswajitdm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Biswajit Dubashi 
Designation  Professor 
Affiliation  JIPMER, Puducherry 
Address  Department of Medical Oncology, JIPMER, Puducherry, India.

Pondicherry
PONDICHERRY
605001
India 
Phone    
Fax    
Email  drbiswajitdm@gmail.com  
 
Source of Monetary or Material Support  
ICMR Adhoc extramural grant 
 
Primary Sponsor  
Name  ICMR Adhoc extramural grant 
Address  V. Ramalingaswami Bhawan, P.O. Box No. 4911 Ansari Nagar, New Delhi - 110029, India Ph: 91-11-26588895 / 91-11-26588980, 91-11-26589794 / 91-11-26589336, 91-11-26588707 Fax: 91-11-26588662 Email:icmrhqds@sansad.nic.in 
Type of Sponsor  Research institution 
 
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 Biswajit Dubashi  JIPMER PONDICHERY  Department of Medical Oncology, JIPMER, dhanvantari nagar,Pondicherry-605001
Pondicherry
PONDICHERRY 
8056338405

drbiswajitdm@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional ethics committee- interventional studies,JIPMER Pondicherry  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  NA  NA 
Intervention  paclitaxel and carboplatin during the waiting period of starting definitive therapy  Injection Paclitaxel 80 mg/m2 in 1 unit NS in Glass bottle IV infusion over 1 hour using DEHP free set and 0.2-micron filter. Injection Carboplatin AUC 2 Calculated using Calverts’ formula in 1 unit 5% dextrose IV infusion over 1 hour.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Female 
Details  Newly diagnosed triple-negative breast cancer.

Age 18 -65 years.

ECOG PS 0/1.

Early and locally advanced breast cancer (T2/T3/T4b with or without node positive).

Planned for neo-adjuvant chemotherapy with anthracycline and taxanes.

Bone marrow function- Hb> 9g%, absolute neutrophil count > 1500/ micL, platelet > 1.5 lakhs/ mic L.

Renal function- Serum creatinine < 1.5 mg%.

Liver function- Serum bilirubin > 1.5 mg%.

Normal cardiac function. 
 
 
ExclusionCriteria 
Details  The patient is not willing to the second biopsy

Pregnant women

Breast feeding mother

Prior history of any other malignancy

Bilateral breast cancer

Patient having active local site infection

Previous allergy to chemotherapy drugs paclitaxel and carboplatin
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The expected outcome from this project is to identify pathological, imaging, and molecular biomarker which would predict pCR in TNBC patients using the window period before NACT.

We would develop a predictive score that will enable us to identify patients who will achieve pCR. This score needs to be validated in a larger population.

Once validated we will prospectively use this score in a clinical trial setting to decide on chemotherapy intensity in TNBC patients planned for NACT.
 
post neoadjuvant chemotherapy, at the end of the surgery 
 
Secondary Outcome  
Outcome  TimePoints 
disease free survival  post surgery followup of patients 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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   N/A 
Date of First Enrollment (India)   15/06/2022 
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="3"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   NA 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Introduction:

The window of opportunity design, which includes administering systemic therapy for a brief period of time between diagnosis of cancer and surgery, has sparked a lot of attention in recent years as a way to assess chemosensitivity in cancer patients prior to definitive treatment. Triple-negative breast cancer (TNBC) is an aggressive tumor subtype with inferior survival. There are limited and unreliable established biomarkers that have been identified before chemotherapy to diagnose patients likely to achieve pathological complete response (pCR).

Objectives:

To study the association of prognostic biomarkers with pCR in patients with non-metastatic TNBC following single-dose paclitaxel and carboplatin during the window period before neoadjuvant chemotherapy (NACT) followed by developing a composite predictive score using above parameters for the assessment of pCR in TNBC before NACT.

Methods:

The non-metastatic triple-negative breast cancer patients will be screened as per the inclusion-exclusion criteria. A baseline biopsy will be done for the assessment of biomarkers prior to intervention followed by a PET scan to study the change in SUV of the tumor. Patients will then receive paclitaxel and carboplatin during the window of opportunity period. The additional biopsy will be done after the intervention to assess the biomarker change followed by an additional PET scan. The post-surgery pathological response will be studied.

Discussion:

There is now fascinating evidence in cancer research; preoperative treatment with chemotherapy during the window period gives substantial prognostic information, which further helps in deciding treatment options. Changes in biomarkers during the short time period and their association with pathological complete response can act as surrogate markers of long-term survival outcomes. 

 
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