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CTRI Number  CTRI/2014/10/005098 [Registered on: 14/10/2014] Trial Registered Prospectively
Last Modified On: 25/03/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To see the effect of INj proluton if given before surgery in patients with high risk operable breast cancer.”  
Scientific Title of Study   A Phase III Randomized Controlled study of Inj. Proluton (Hydroxyprogesterone caproate) as single dose preoperative therapy in patients with high risk operable breast cancer.”  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr SVS DEO 
Designation  Professor Surgical Oncology 
Affiliation  AIIMS 
Address  Room NO 244 IRCH AIIMS New Delhi

South
DELHI
110029
India 
Phone  9811356594  
Fax    
Email  svsdeo@yahoo.co.in  
 
Details of Contact Person
Scientific Query  
Name  Dr SVS DEO 
Designation  Professor Surgical Oncology 
Affiliation  AIIMS 
Address  Room NO 244 IRCH AIIMS New Delhi

South
DELHI
110029
India 
Phone  9811356594  
Fax    
Email  svsdeo@yahoo.co.in  
 
Details of Contact Person
Public Query  
Name  Dr Yogesh Kumar 
Designation  Senior Research Officer 
Affiliation  AIIMS 
Address  Room NO 216 IRCH AIIMS New Delhi

South
DELHI
110029
India 
Phone  9953091867  
Fax    
Email  yogidr27@yahoo.co.uk  
 
Source of Monetary or Material Support  
Tata memorial hospital Mumbai  
 
Primary Sponsor  
Name  Tata memorial hospital 
Address  Dr. Ernest Borges Road Parel Mumbai 400 012 Maharashtra India  
Type of Sponsor  Research institution and hospital 
 
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 SVS DEO  Room No 244 Dr BRA Institute Rotary Cancer Hospital,AIIMS  AIIMS
New Delhi
DELHI 		 9811356594

svsdeo@yahoo.co.in 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 17  
Name of Committee  Approval Status 
AIIMS  Approved 
Cancer Institute Ethics Committee-WAI  Approved 
Ethics Committee SPMG & AG  Approved 
Ethics Committee-AIIMS  Approved 
GCRI/GCS Ethics committee  Approved 
Hospital Ethics Committee-SMS  Approved 
Institute Ethics Committee-NEIGRIHMS  Approved 
Institutional Ethics Committe-Max Super Speciality patparganj  Approved 
Institutional Ethics Committe-SGPGIe  Approved 
Institutional Ethics Committee  Approved 
Institutional Ethics Committee-AIMS & RC  Approved 
Institutional Ethics Committee-BBCI  Approved 
Institutional Ethics Committee-BIACH & RI  Approved 
Institutional Ethics Committee-Thangame  Approved 
Jahangir Clinical Development Centre Institutional Review Board  Approved 
Kolhapur Cancer Centre Institutional Ethics Committee  Approved 
Sterling Hospital Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  High risk operable breast cancer,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  controll  controll 
Intervention  Inj Proluton   Hydroxyprogesterone caproate, 500mg IM.Frequency and Duration - Single Injection progesterone 500 mg IM will be given 3-11 day prior to surgery. In case surgery is delayed beyond 14 days, 250 mg of injection progesterone will be administered and surgery wil be carried out within one week of repeated dose.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Female 
Details  1 Patients willing to provide informed consent.
2 Women 18 years of age or more.
3 Operable Breast cancer patients with clinically or radiologically node positive disease
 
 
ExclusionCriteria 
Details  1 Patients with a prior history of any malignancy.
2 Patient with a prior history of excision biopsy.
3 Patient receiving preoperative chemotherapy
4 Women who are pregnant, breast-feeding.
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
To see the effect of single dose of preoperative Inj. Proluton (Hydroxyprogesterone caproate) on disease-free survival (DFS) at 5 years.  5 years 
 
Secondary Outcome  
Outcome  TimePoints 
To see the effect of single dose of preoperative Inj. Proluton (Hydroxyprogesterone caproate) on overall survival (OS) at 5 years  5 yrs  
 
Target Sample Size   Total Sample Size="860"
Sample Size from India="860" 
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)   25/10/2014 
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="5"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The retrospective analysis of 324 patients3 that showed that as compared to surgery performed during the follicular phase (unopposed estrogen), those who received surgery in the luteal phase (estrogenic effect opposed by progesterone) resulted in a better overall survival.  In this study, the presence of high levels of progesterone was associated with an improvement in overall survival in the lymph node positive subvgroup.
A randomized prospective trial was thus initiated in 1997 at the Tata Memorial Hospital, Mumbai, India to compare effects of primary progesterone prior to surgery versus standard care in women with early breast cancer with disease-free survival as the primary end-point.
At a median follow up of 65 months6 among 976 eligible patients, 273 recurrences and 202 deaths were recorded. In progesterone versus control groups, 5-year DFS and OS were 73.9% versus 70.2% (HR=0.87, 95%ci=0.68-1.09, p=0.23) and 80.2% versus 78.4% (HR=0.92, 95%ci=0.69-1.21, p=0.53) respectively.  In 471 node positive patients, the 5-year DFS and OS in progesterone versus control groups were 65.3%versus 54.7% (HR=0.72, 95%CI=0.54-0.97, p=0.02) and 75.7% versus 66.8% (HR=0.70, 95%CI=0.49-0.99, p=0.04) respectively. In multivariate analysis DFS was significantly improved with progesterone in node positive patients (adjusted HR=0.71, 95%CI=0.53-0.95, p=0.02) while there was no significant effect in node negative patients (interaction p=0.04 for DFS and p=0.02 for OS).
Based on the above results, and the fact that the study was carried out in a single institution, it requires to be replicated at other centres as well. It is, therefore, being proposed to carry out the study as a multicentre study in different geographical areas in women with high risk (and node positive) operable breast cancer.
 
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