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CTRI Number  CTRI/2012/10/003065 [Registered on: 17/10/2012] 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   Pivotal study in breast cancer patients investigating efficacy and safety of LA-EP2006 and Neulasta®. 
Trial Acronym  PROTECT-2 
Secondary IDs if Any  
Secondary ID  Identifier 
LA-EP06-302, Version 2.2 dated 19 October 2011  Protocol Number 
NCT01516736  ClinicalTrials.gov 
 
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

Gurgaon
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

Bangalore
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
Malaysia
Russian Federation
United States of America  
Sites of Study
Modification(s)  
No of Sites = 23  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chanchal Goswami  B. P. Poddar Hospital & Medical Research Ltd  Medical Oncology Department, 71/1, Humayun Kabir Sarani, Block- G, New Alipore, Kolkata- 700053, India
Kolkata
WEST BENGAL 		 919830055035

drcgoswami@gmail.com 
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 Venkata Satya Suresh Atilli  BIBI General Hospital & Cancer Centre  16-3-991/1/C, Govt. Printing Press Road, Malakpet, Hyderabad - 500024, India
Hyderabad
ANDHRA PRADESH 		 914024528144

sureshattili@yahoo.com 
Dr Mamillapalli Gopichand  City Cancer Center  33-25-33, Ch. Venkata Krishnayya Street, Suryarao Pet, Vijayawada, Andhra Pradesh, India- 520002
Krishna
ANDHRA PRADESH 		 918662432180
918662430871
mgopichand@yahoo.com 
Dr Rajnish Nagarkar  Curie Manavata Cancer Centre  Opposite Mahamarg Bus StandMumbai Naka, Nashik - 422004, Maharashtra, INDIA
Nashik
MAHARASHTRA 		 912532592666
912532594866
drraj@manavatacancercentre.com 
Dr Subhashini John  Dr. Ida B Scudder Cancer Centre  Department of Radiation Therapy-II, Christian Medical College, Vellore-632004, Tamil Nadu, India
Vellore
TAMIL NADU 		 914162282046
914162235555
subha@cmcvellore.ac.in 
Dr Sadanand Karandikar  Galaxy Laparoscopy Institute  25-A, Karve Road, Pune - 411004 Maharashtra, India.
Pune
MAHARASHTRA 		 912030244102
912025466122
Skaran44@gmail.com 
Dr Balaji Shewalkar  Government Medical College & Hospital  Dept.of Radiotherapy Oncology Government Medical College & Hospital, Aurangabad 431001,Maharashtra,India
Aurangabad
MAHARASHTRA 		 912402400640
912402400640
bkrish_e@rediffmail.com 
Dr Chirag Desai  Hemato-Oncology Clinic, Ahmedabad Pvt. Ltd.  1st Floor, Vedanta Institute of Medical science, stadium commerce college road, Navrangpura, Ahmedabad, Gujarat, India
Ahmadabad
GUJARAT 		 917940042223
917940042225
Chiragdesai.oncology@gmail.com 
Dr Niraj Bhat  Kailash Cancer Hospital and Research Centre  P.O.Goraj, TA: Waghodiya, Baroda (Gujarat) Vadodara (Goraj) 391760, India
Vadodara
GUJARAT 		 912668261880
912668268048
medonc12@gmail.com 
Dr Krishna Prasad  Kasturba Medical College & Hospital  Department of Oncology, Attavar, Mangalore - 575001, India
Dakshina Kannada
KARNATAKA 		 918242425092
918242425092
drkrishnaprasad@hotmail.com 
Dr Rajendra Kumar  King George Medical University  King George Medical University Department of Radiotherapy, Lucknow – 226003, Uttar Pradesh, India
Lucknow
UTTAR PRADESH 		 915222258877
915222258877
drrkumar10@gmail.com 
Dr Chirmana Haritha   M.S.Patel Cancer Centre  Medical Oncology, M.S.Patel Cancer Centre, Shree Krishna Hospital and Medical Research Centre, Karamsad-388325, Gujarat, India
Anand
GUJARAT 		 912692228265
912692222411
ritu80@rediffmail.com 
Dr Murali Krishna Voona  Mahatma Gandhi Cancer Hospital and Research Institute  1/7, MVP Colony, Visakhapatnam – 530017
Visakhapatnam
ANDHRA PRADESH 		 918912551811

muralivoonna@yahoo.com 
Dr Amit Rauthan  Manipal Hospital  Clinical Research Center, 6th Floor, 98, HAL Airport Road, Bangalore -560017
Bangalore
KARNATAKA 		 918025024444
918025266757
amitrauthar@yahoo.com 
Dr Randeep Singh  Max Super Specialty Hospital (A Unit of Balaji Medical and Diagnostic Research Centre)  Department of Oncology, 108-A, Indraprastha Extension, Patparganj, Delhi-110092, INDIA
East
DELHI 		 911143033333
911143170823
drrandeep@yahoo.co.in 
Dr Tapan Saikia  Prince Aly Khan Hospital  Aga Hall, Nesbit Road, Mazagaon, Mumbai-400010, Maharashtra, INDIA
Mumbai
MAHARASHTRA 		 912223777800
912223777900
Tapan.Saikia@gmail.com 
Dr Rajiv Ranjan Prasad  Regional Cancer Centre  Regional Cancer Centre, IGIMS, Sheikhpura, Patna- 800014, India
Patna
BIHAR 		 916122280119

rajiv_rprasad@yahoo.com 
Dr Ramakrishnan Gopal  S. L. Raheja Hospital  Raheja Rugnalaya Marg, Mahim, Mumbai - 400016, Maharashtra, INDIA
Mumbai
MAHARASHTRA 		 912224446163
912224449418
rgopal1@gmail.com 
Dr Vijay Bhagwan Tuljapurkar   Shri Siddhi Vinayak Ganapati Cancer Hospital  Sangli Road, Miraj - 416410, Maharashtra, India
Sangli
MAHARASHTRA 		 912332211795
912332211603
vtuljapurkar@gmail.com 
Dr Raju Naidu  St. Joseph’s General Hospital  Opp. AC College, Guntur- 522004, Andhra Pradesh, India
Guntur
ANDHRA PRADESH 		 918632234049
918632234049
dsrajunaidu@yahoo.com 
Dr Rajendra Arora  Sujan Surgical Cancer Hospital and Amravati Cancer Foundation,  52/B, Shankar Nagar, Main Road, Amravati, Maharashtra- 400601
Amravati
MAHARASHTRA 		 917212671496
917212578568
rsaroradr@gmail.com 
Dr Subramanian Sundaram  V.S. Hospital  13, East, Spur Tank Road, Chetpet, Chennai - 600031, India
Chennai
TAMIL NADU 		 914442001000
914428191021
clinicalresearch.vsh@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 23  
Name of Committee  Approval Status 
Amravati Ethics Committee, Amravati, Dr. Rajendra Arora  Approved 
Axiom Lifesciences Private Limited Independent Ethics Committee, Pune, Dr. Sadanand Karandikar  Submittted/Under Review 
ETHICAL COMMITTEE, B.P.PODDAR HOSPITAL & MEDICAL RESEARCH LTD, Kolkata, Dr. Chanchal Goswami  Approved 
Ethical Trial of Health In Community (ETHIC) Committee, Surat, Dr. Tanveer Maksud  Approved 
Ethics Committee Madras Clinical Research center, VS Hospital, Chennai, Dr. Subramanian Sundaram  Submittted/Under Review 
Ethics Committee of CIMS, Ahmedabad, Dr Chirag Desai  Submittted/Under Review 
Ethics committee of Manipal Hospitals, Bangalore, Dr. Amit Rauthan  Approved 
Human Research Ethics Committee, Karamsad, Dr. Chirmana Haritha   Approved 
Institute Ethics committee, Patna, Dr. Rajiv Ranjan Prasad  Submittted/Under Review 
Institution Ethics Committee, Hyderabad, Dr. Venkata Satya Suresh Atilli  Submittted/Under Review 
Institutional Ethics Committee, City Cancer Centre, Vijayawada, Dr. Mamillapalli Gopichand   Submittted/Under Review 
Institutional Ethics Committee, Delhi, Dr. Randeep Singh  Submittted/Under Review 
Institutional Ethics committee, Government Medical College and Hospital, Aurangabad, Dr. Balaji Shewalkar  Submittted/Under Review 
Institutional Ethics Committee, Lucknow, Dr. Rajendra Kumar  Submittted/Under Review 
Institutional Review Board (IRB) Christian Medical College, Vellore, Dr. Subhashini John  Submittted/Under Review 
Institutional Review Board Prince Aly Khan Hospital, Mumbai, Dr. Tapan Saikia  Submittted/Under Review 
Jehangir Clinical Development Center Institutional Review Board, Miraj, Dr. Vijay Bhagwan Tuljapurkar   Approved 
Kailash Cancer & Medical Center, Goraj, Vadodara, Dr. Niraj Bhat  Approved 
Mahatma Gandhi Cancer Hospital & Research Centre,Institutional Review Board, Visakhapatnam, Dr. Murali Krishna Voona  Approved 
Manavata Clinical Research Institute, Professional Ethics Committee, Nasik, Dr. Rajnish Nagarkar  Submittted/Under Review 
Manipal University Ethics Committee, Manipal, Mangalore, Dr. Krishna Prasad  Submittted/Under Review 
S.L.Raheja IRB, Mumbai, Dr. Ramakrishnan Gopal  Submittted/Under Review 
St. Joseph’s Institutional Ethics Committee, Guntur, Dr. Raju Naidu  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 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 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.
 		 during all the Cycles of chemotherapy. 
 
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)   20/10/2012 
Date of Study Completion (India) Date Missing 
Date of First Enrollment (Global)  12/03/2012 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="6"
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. 

The trial is also conducted at Puerto Rico (Other). 

 
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