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CTRI Number  CTRI/2012/09/003030 [Registered on: 28/09/2012] Trial Registered Prospectively
Last Modified On: 12/02/2014
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A study to evaluate the Efficacy and Safety of LA-EP2006 and Neulasta® in patients with breast cancer. 
Scientific Title of Study   A randomized, double-blind, parallel-group, multi-center Phase 3 comparative study investigating efficacy and safety of LA-EP2006 and Neulasta® in breast cancer patients treated with myelosuppressive chemotherapy.  
Trial Acronym  PROTECT-1 
Secondary IDs if Any  
Secondary ID  Identifier 
2011-004532-58  EudraCT 
LA-EP06-301, Version 1.1 (Final) dated 21 October 2011  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name   
Designation   
Affiliation   
Address 




 
Phone    
Fax    
Email    
 
Details of Contact Person
Scientific Query  
Name  Somaraju Lokaranjan 
Designation  Project Manager 
Affiliation  PharmaNet-i3 
Address  701–703, Tower B, Millennium Plaza, Sushant Lok – 1, Gurgaon, Haryana –122002, India


HARYANA
122002
India 
Phone  914040155187  
Fax  914040155187  
Email  slokaranjan@pharmanet-i3.com  
 
Details of Contact Person
Public Query  
Name  Sanjay Kabra  
Designation  Director – Clinical Research 
Affiliation  PharmaNet-i3 
Address  Unit 1101, Level 11, Millenia Tower B 1 and 2 Murphy Road Bangalore KARNATAKA 560 008 India


KARNATAKA
560008
India 
Phone  912240957478  
Fax  912240957499  
Email  skabra@pharmanet-i3.com  
 
Source of Monetary or Material Support  
Sandoz GmbH , Biochemiestrasse 10, 6250 Kundl, Austria 
 
Primary Sponsor  
Name  Sandoz GmbH 
Address  Biochemiestrasse 10, 6250 Kundl, Austria 
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India
Russian Federation  
Sites of Study
Modification(s)  
No of Sites = 21  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pavithran Keechilat  Amrita Institute of Medical Sciences  Amrita Lane, 682 041- Cochin, Ernakulam, Kerala, India
Ernakulam
KERALA 		 914842802177

Pavithrank@aims.amrita.edu 
Dr Tanveer Maksud  Bharat Cancer Hospital & Research Institute  Manav Daya Trust Complex, Surat - Bardoli Road, Saroli - 395010, Dist. Surat, Gujarat, INDIA
Surat
GUJARAT 		 912612641002
912612641004
tanveermaksud@yahoo.com 
Dr Anand Pathak  Cancer Care Clinic and Hospital  5th Floor, Vasant Sheela Tower, Lokmat Square, Nagpur - 440 012, India
Nagpur
MAHARASHTRA 		 917122430465
9171222461565
jueely1194@yahoo.co.in 
Dr Ajay Mehta  Central India Cancer Research Institute  11 Shankar Nagar, West High Court Road, Nagpur- 440010 India
Nagpur
MAHARASHTRA 		 917122520956
917122523404
ajayonco@hotmail.com 
Dr Jaydip Bisawas  Chittaranjan National Cancer Institute  37.S.P Mukherjee Road, Jatin Das Metro Station, Hazra more, opposite to Asutosh College, Kolkata – 700026, West Bengal, INDIA
Kolkata
WEST BENGAL 		 913324759313
913324757606
drjbiswas.cnci@gmail.com 
Dr Mamillapalli Gopichand   City Cancer Centre  # 33-25-33, Ch. Venkata Krishnayya Street, Suryarao Pet, Vijayawada, Andhra Pradesh, - 520002, India
Krishna
ANDHRA PRADESH 		 918662432180
918662430871
mgopichand@yahoo.com 
Dr Chetan Deshmukh  Deenanath Mangeshkar Hospital and Research Centre  Near Mhatre Bridge, Erandwane, Pune- 411004, Maharashtra, India
Pune
MAHARASHTRA 		 912066023000
912066023025
drchetandeshmukh@gmail.com 
Dr Rajesh Kumar Grover  Delhi State Cancer Institute  Dilshad Garden, Delhi- 110095, India
East
DELHI 		 911122110303
911122110505
dsci.delhi@yahoo.co.in 
Dr Anish Maru  Dharamshila Hospital and Research Centre  Near New Ashok Nagar Metro Station, Vasundhara Enclave, Delhi - 110096, India
East
DELHI 		 911143066353
911122617770
anishmaru@yahoo.com 
Dr Srinivasan Krishnan  Dr. Rai Memorial Medical Centre  Anna Salai, Chennai - 600018, India
Chennai
TAMIL NADU 		 919952933735

krishnan_dr@yahoo.com 
Dr Balaji Shewalkar  Government Medical College & Hospital  Department of Radiotherapy Oncology Aurangabad-431001, Maharashtra, India
Aurangabad
MAHARASHTRA 		 912402341812

drshewalkarsite@yahho.co.in 
Dr Shona Nag  Jehangir Clinical Development Centre  32, Sasson Road, Pune – 411001, Maharashtra, India
Pune
MAHARASHTRA 		 9120267268804
912026059319
shona_nag@hotmail.com 
Dr Krishna Prasad   Kasturba Medical College Hospital  Department of Oncology, Attavar, Mangalore - 575001, India
Dakshina Kannada
KARNATAKA 		 918242425092

drkrishnaprasad@hotmail.com 
Dr Venkata Satya Suresh Attili  Kidwai Memorial Institute of Oncology  BIBI General Hospital & Cancer Centre, 16-3-991/1/C, Govt. Printing Press Road, Malakpet, Hyderabad - 500024, India
Hyderabad
ANDHRA PRADESH 		 919246243034

sureshattili@yahoo.com 
Dr Ravi Mohan  King George Hospital  Andhra Medical College, Department of Medicine New Block, Visakhapatnam, Andhra Pradesh- 530002, India
Visakhapatnam
ANDHRA PRADESH 		 91891731343
918912714644
oncoravi@rediffmail.com 
Dr Suraj Pawar  Kolhapur Cancer Centre  Near Pune Bangalore Highway, Kolhapur, Maharashtra, India
Kolhapur
MAHARASHTRA 		 912312532034

kolhapurcancercentre@gmail.com 
Dr Chirmana Haritha  M.S. Patel Cancer Centre  Medical Oncology, Shree Krishna Hospital and Medical Research Centre, Karamsad-388325, Gujarat, India
Anand
GUJARAT 		 912692228265
912692222411
Ritu80@rediffmail.com 
Dr Kirushna Kosam  Meenakshi Mission Hospital and Research Centre   Lake Area, Melur Road, Madurai - 625107, Tamil Nadu
Madurai
TAMIL NADU 		 914524263000
914522586353
drkskk@yahoo.com 
Dr Minish Jain  Ruby Hall Clinic  Medical Oncology, 40, Sassoon Road, Pune, 411 001, Maharashtra, India
Pune
MAHARASHTRA 		 912026123391
912066455563
minishjain009@gmail.com 
Dr Mukul Goyal  SeaRoc Cancer Center  SK Soni Hospital, Sikar Road, Sec-5, Vidhyadhar Nager, Jaipur- 302013, Rajasthan, India
Jaipur
RAJASTHAN 		 911412233337

drmukylgoyal@yahoo.in 
Dr Shailesh Bondarde  Shatabdi Superspeciality Hospital  Suyojit City Centre, Opp. Mahamarg Bus Stand, Mumbai Naka, Nashik- 422005, India
Nashik
MAHARASHTRA 		 912536639004
912532502105
shaileshbondarde@yahoo.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 21  
Name of Committee  Approval Status 
Central India Cancer Research Institute ethics committee, Nagpur, Dr. Ajay Mehta  Approved 
Ethical Review Board, Madurai, Dr Kirushna Kosam  Approved 
Ethical Trial of Health In Community (ETHIC) Committee, Surat, Dr Tanveer Maksud  Submittted/Under Review 
Global Health Concern Ethics Committee, Nagpur, Dr Anand Pathak  Approved 
Human Research Ethics Committee, Karamsad, Dr Chirmana Haritha  Submittted/Under Review 
Institutional Ethics Committee - Amrita Institite of Medical Sciences And Research Center, Cochin, Dr Pavithran Keechilat  Submittted/Under Review 
Institutional Ethics Committee - Chittaranjan National Cancer Institute, Kolkata, Dr Jaydip Biswas  Submittted/Under Review 
Institutional Ethics Committee - City Cancer Centre, Vijayawada, Dr. Mamillapalli Gopichand   Submittted/Under Review 
Institutional Ethics Committee - Deenanath Mangeshkar Hospital And Research Centre, Pune, Dr Chetan Deshmukh  Submittted/Under Review 
Institutional Ethics Committee - Dharamshila Hospital and Research Centre, Delhi, Dr Anish Maru  Submittted/Under Review 
Institutional Ethics Committee -Bibi General Hospital & Cancer Centre, Hyderabad, Dr. Venkata Satya Suresh Attili   Submittted/Under Review 
Institutional Ethics committee -Government Medical College and Hospital, Aurangabad, Dr. Balaji Shewalkar   Submittted/Under Review 
Institutional Ethics Committee, Dr.RMMC-IEC, Chennai, Dr Srinivasan Krishnan   Approved 
Institutional Ethics Committee, King George Hospital, Visakhapatnam, Dr Ravi Mohan  Approved 
Jehangir Clinical Development Centre IRB, Pune, Dr Shona Nag  Approved 
Kolhapur Independent Ethics Committee, Kolhapur, Dr Suraj Pawar  Submittted/Under Review 
Manipal University Ethics Committee -Manipal, Mangalore, Dr Krishna Prasad   Submittted/Under Review 
Northern Independent Ethics Committee, Delhi, Dr. Rajesh Kumar Grover  Submittted/Under Review 
Poona Medical Research Foundation, Pune, Dr Minish Jain  Approved 
SEAROC Ethics Committee, Jaipur, Dr Mukul Goyal  Submittted/Under Review 
Shatabdi Hospital Ethics Committee, Nasik, Dr Shailesh Bondarde  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Prevention of neutropenic complications in breast cancer patients treated with myelosuppressive chemotherapy,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  LA-EP2006   Therapy: LA-EP2006 6mg s.c, on Day 2 of each chemotherapy cycle. Total six TAC chemotherapy cycles. Duration: The total study duration is approximately 10 months. 
Comparator Agent  Neulasta®  Therapy: Neulasta® 6mg s.c, on Day 2 of each chemotherapy cycle. Total six TAC chemotherapy cycles. Duration: The total study duration is approximately 10 months. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Female 
Details  1. histologically proven breast cancer
2. eligible for six cycles of neoadjuvant or adjuvant chemotherapy
 
 
ExclusionCriteria 
Details  1. History of cancer
2. Active infection
3. Known immunodeficiency syndrome
4. Previous therapy with any G-CSF (granulocyte-colony stimulating factor) product
Other protocol-defined inclusion/exclusion criteria may apply.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Mean duration of Grade 4 neutropenia during Cycle 1 of chemotherapy.  during Cycle 1 of chemotherapy. 
 
Secondary Outcome  
Outcome  TimePoints 
Incidence of febrile neutropenia.
Incidence, occurrence and severity of (serious) adverse events.
 		 across all cycles 
 
Target Sample Size   Total Sample Size="302"
Sample Size from India="75" 
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   03/10/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  10/07/2012 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details    
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

The study will assess the efficacy of LA-EP2006 compared to Pegfilgrastim with respect to the mean duration of severe neutropenia during treatment with myelosuppressive chemotherapy in breast cancer patients.

 
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