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CTRI Number  CTRI/2020/04/024456 [Registered on: 03/04/2020] Trial Registered Prospectively
Last Modified On: 12/10/2020
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   To study the effect of two drugs BP02-Trastuzumab and Herceptin®-EU in Patients with HER2-Positive Early Breast Cancer (EBC)and HER2-Positive Metastatic Breast Cancer (MBC) 
Scientific Title of Study   A Multicenter, Double-Blind, Randomized, Parallel- Group, Active-Controlled, Two Part, Phase III, Global Study to Evaluate the Pharmacokinetics, Efficacy and Safety of BP02 (Trastuzumab) in comparison with Herceptin®-EU in Patients with HER2-Positive Early Breast Cancer (EBC) and HER2-Positive Metastatic Breast Cancer (MBC). 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
CR201-18, Version 1.0 Dated 25.06.2019  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Subhra Lahiri 
Designation  Associate Vice President 
Affiliation  AXIS Clinicals Ltd 
Address  AXIS Clinicals Ltd 1 121 1 Miyapur Hyderabad500049 Telangana INDIA

Hyderabad
TELANGANA
500049
India 
Phone  8886221089  
Fax  40408060  
Email  Subhra.L@axisclinicals.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Subhra Lahiri 
Designation  Associate Vice President 
Affiliation  AXIS Clinicals Ltd 
Address  AXIS Clinicals Ltd 1 121 1 Miyapur Hyderabad500049 Telangana INDIA

Hyderabad
TELANGANA
500049
India 
Phone  8886221089  
Fax  40408060  
Email  Subhra.L@axisclinicals.com  
 
Details of Contact Person
Public Query
 
Name  Dr Subhra Lahiri 
Designation  Associate Vice President 
Affiliation  AXIS Clinicals Ltd 
Address  AXIS Clinicals Ltd 1 121 1 Miyapur Hyderabad500049 Telangana INDIA

Hyderabad
TELANGANA
500049
India 
Phone  8886221089  
Fax  40408060  
Email  Subhra.L@axisclinicals.com  
 
Source of Monetary or Material Support  
CuraTeQ Biologics GmbH c/o Moore Stepehns Luzern AG, Obergrundstrasse 61, 6003 Luzern  
 
Primary Sponsor  
Name  CuraTeQ Biologics GmbH 
Address  CuraTeQ Biologics GmbH c/o Moore Stepehns Luzern AG, Obergrundstrasse 61, 6003 Luzern  
Type of Sponsor  Pharmaceutical industry-Global 
 
Details of Secondary Sponsor  
Name  Address 
Aurobindo Biologics   (Unit-17, A Division of Aurobindo Pharma Ltd, India), Hyderabad 
 
Countries of Recruitment     Bangladesh
India  
Sites of Study  
No of Sites = 62  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Prasant Parida  Acharya Harihar Regional Cancer Centre  Department of Oncology Cuttack753 007 Odisha
Cuttack
ORISSA 
9583388288

drprasantdm@gmail.com 
Dr Ajay Gogia  All India Institute Of Medical sciences   All India Institute Of Medical sciences First floor Department of Radiotherapy and Oncology Ansari Nagar New Delhi 110029 India
South
DELHI 
9013000642

ajaygogia@gmail.com 
Dr Saroj Kumar Das Majumdar  All India Institute of Medical Sciences Bhubaneshwar  Department of Radiotherapy,All India Institute of Medical Sciences, Sijua , Patrapada, Bhubaneswar, Odisha 751019
Khordha
ORISSA 
9438884066

sarojmajumdar@gmail.com 
Dr P N Mohapatra  Apollo Gleneagles Hospitals  Apollo Gleneagles Hospitals Apollo Hospital Kolkata Oncology Dept 58 Canal circular road Kolkata
Kolkata
WEST BENGAL 
9674311610

Prabrajya.mohapatra@rediffmail.com 
Dr Priya Tiwari  Artemis Hospitals  Department of Oncology Sector 51 Gurugram Haryana 122001
Gurgaon
HARYANA 
8377828241

priya.tiwari@artemishospitals.com 
Dr Ayyagari Santa  Basavatarakam Indo American Cancer Hospital & Research Institute  Department of Medical Oncology, Basavatarakam Indo American Cancer Hospital & Research Institute, Road No 10, Banjara Hills, Hyderabad-500034, Telangana State, India.
Hyderabad
TELANGANA 
9848125174

santaa2002@yahoo.com 
Dr Kalyan Kusum Mukherjee  Chittaranjan Cancer Hospital  37ShyamaPrasadMukherjee Rd Bakul Bagan Kalighat West Bengal 700026
Kolkata
WEST BENGAL 
9051377724

kkmukherjee4u@hotmail.com 
Dr Dhananjay Kelkar  Deenanath Mangeshkar Hospital and Research Center  Department of surgical oncology,Deenanath Mangeshkar Hospital Road Near Mhatre Bridge Erandwane Pune Maharashtra 411004
Pune
MAHARASHTRA 
9158885177

dskelkar@gmail.com 
Dr Amit Kumar Dhiman  Deep Hospital  Department of Clinical Research,ground Floor,Deep Heart Center,478 / L, Model Town, Ludhiana-141002
Ludhiana
PUNJAB 
9779898339

dramit.meet@gmail.com 
Dr Amit Agarwal  Dr BL Kapur Memorial Hospital  Clinical Research Department, 7th floor, B block (med. Admin room) BLK Super Speciality Hospital, Pusa Road, New Delhi-110005
New Delhi
DELHI 
9971611311

dipaliamit@hotmail.com 
Dr Prashant Kumbhaj   Ganadhipati Purushottam Shekhawati Hospital Research  A/2 4th Floor Opp Time Square Vidhyadhar Nagar Jaipur 302023 RAJASTHAN
Jaipur
RAJASTHAN 
7869409560

drprashantkumbhaj@yahoo.com 
Dr Manoj Mahajan  GBH General Hospital & GBH Memorial Cancer Hospital  Department of Medical Oncology,Ground Floor,GBH Memorial Cancer Hospital 101 Kothi Bagh Bhatt Ji Ki Bari Meera Girls College Road Udaipur 313001 Rajasthan
Udaipur
RAJASTHAN 
9818051316

Drmanoj.mahajan@gmail.com 
Dr Vijay Kumar Mahobia  Government Medical College  Department of Radiation Therapy & Oncology Government Medical College and Hospital Medical College Square Road Nagpur 440003 Maharashtra India
Nagpur
MAHARASHTRA 
09881287465

drvijaymahobia@yahoo.com 
Dr Murali Subramanian  Gurushree HiTech Multi Speciality Hospital Bangalore  Department of Medical oncology,Gurushree Hi-Tech Multi Specialty Hospital 1558 Opp Chandra Layout Bus Stand Chandra Layout Vijayanagar Bengaluru Urban Karnataka 560040
Bangalore
KARNATAKA 
9945813327

muralis_14@yahoo.com 
Dr Susant Paikara  HCG  Hcg panda cancer hospitalCuttack Odisha 753051
Cuttack
ORISSA 
9437147517

drskppgi@gmail.com 
Dr L P Bhaskar Bhuvan  HCG CANCER CENTER Vishakhapatnam  Department of oncology,HCG Cancer Centre 10 11 & 12 APIIC Health City Arilova Chinagadili Visakhapatnam Andhra Pradesh 530040
Visakhapatnam
ANDHRA PRADESH 
9154144100

bhaskarlp60@gmail.com 
Dr G Ranga Raman  HCG City Cancer Center  Department of clinical research, 4th floor,HCG City Cancer Centre 33-25-33 CH Venkata Krishnayya street Suryarao pet Vijayawada 522002 Andhra Pradesh India
Krishna
ANDHRA PRADESH 
97050859391

rangaraman83@gmail.com 
Dr Rajnish Nagarkar   HCG Manavata Cancer Centre  Clinical research department, first floor,HCG Manavata Cancer Centre Nashik Nashik Fwy Opp Mahamarg Bus Stand Renuka Nagar Nashik Maharashtra 422011
Nashik
MAHARASHTRA 
9823061929

drrag@ManavataCancerCentre.com 
Dr Ajay Mehta  HCG Nagpur  Mouja Wanjri Khasra No50 51 Ring Road Near Automotive Square Kalam Bande Nawaz Nagar Binaki Nagpur Maharashtra 440017
Nagpur
MAHARASHTRA 
9823190192

drajay.mehta@hcgoncology.com 
Dr Soumya Surath Panda  IMS&SUM Hospital  At-Dept. of Medical oncosciences,Institute of Medical Sciences & SUM Hospital, K8, Kalinga Nagar, shampur, Ghatika, Khandagiri,Bhubaneswar, Odisha- 751003
Khordha
ORISSA 
06742386281

ssb_SCB@yahoo.com 
Dr Jitendra Kumar Verma  JK Cancer Center   Department of Radiotherapy/ Radiation Oncology JK Cancer Institute Rawatpur crossing Kanpur 208005 UP INDIA
Kanpur Nagar
UTTAR PRADESH 
9936151385

drjitendra_kgmc@yahoo.com 
Dr Shiv Rajan   King Georges Medical University  Department of Surgical Oncology,3rd floor, Shatabdi Phase II, King Georges Medical University, Shah Mina Rd, Chowk, Lucknow, Uttar Pradesh 226003 India
Lucknow
UTTAR PRADESH 
6393682289

shivrajan.194@gmail.com 
Dr Saurabh Prasad  Kingsway Hospitals, Nagpur  Department of Clinical Research, Kingsway Hospitals, Nagpur,44, Kingsway Rd, near Kasturchand Park, Mohan Nagar, Nagpur, Maharashtra 440001, India
Nagpur
MAHARASHTRA 
07066580511

prasad123@gmail.com 
Dr Ashish Agrawal   Kiran Hospital Multi Super specialty Hospital  Department of medical oncology,Kiran Super Multispeciality Hospital Vasta Devdi Road Near Sumul Dairy Rd Katargam Surat Gujarat 395004
Surat
GUJARAT 
9979530073

onco.kh@gmail.com 
Dr Prakash Saxena  KMC Hospital  Department of Radiotherapy & Oncology, KMC Hospital, , Attavar, Mangalore, Karnataka 575001, India
Dakshina Kannada
KARNATAKA 
08242445858

pu.saxena@manipal.edu 
Dr Yogesh Anap  Kolhapur Cancer Centre  Department of Radiotherapy,Kolhapur Cancer Center S 238 Opp Mayur Petrol Pump Gokul Shirgaon, Kolhapur 416234 Maharashtra India
Kolhapur
MAHARASHTRA 
9867155930

yogesh.anap1@gmail.com 
Dr Viraj Vijay Borgaonkar  Kripamayi Hospital   Department of Oncology Bhapkar Marg Samadhan Colony KonkanwadiMaharashtra 431005
Aurangabad
MAHARASHTRA 
9763073555

viraj.oncosurg@gmail.com 
Dr Ravi Kumar Narayan Wategaonkar  Lokmanya Hospital Cancer care and Research  Lokmanya Hospital 314B Teko Road Chinchwad 411033 Maharastra
Pune
MAHARASHTRA 
9823602626

rnwategaonkar@gmail.com 
Dr Praveena Voonna  Mahatma Gandhi Cancer Hospital  Mahatma Gandhi Cancer Hospital & Research Institute,Clinical research Department, room no.29 Plot No 1 Sector 7 Mvp Colony Visakhapatnam Andhra Pradesh 530017
Visakhapatnam
ANDHRA PRADESH 
9502885780

praveena.voonna@gmail.com 
Dr Balaji Shewalkar  Marathwada regional Cancer Center and Research Institute  Dept of Radiotherapy & Oncology Marathwada Regional Cancer Centre & Research Institute GMCH Aurangabad 431001 Maharashtra India
Aurangabad
MAHARASHTRA 
8806660392

bkrish1970@gmail.com 
Dr Preetam Jain  Masina Hospital  Masina Hospital Sant Savata Mali Marg Cemetery Naralwadi Byculla Mumbai Maharashtra 400027
Mumbai
MAHARASHTRA 
9979686262

masina.clinicals@gmail.com 
Dr Kishore Singh  Maulana Azad Medical College Department of Lok nayak Hospital  Maulana Azad Medical College Department of Oncology, Lok nayak Hospital 2 Bahadur Shah Zafar Marg Maulana Azad Medical College Campus Balmiki Basti New Delhi Delhi 110002
New Delhi
DELHI 
9810320341

drkishoresingh@hotmail.com 
Dr Asit Ranjan Deb  Medical College, Kolkata  Department of Radiotherapy, Medical College & Hospital Kolkata 88 College St Calcutta Medical College College Square Kolkata West Bengal 700073
Kolkata
WEST BENGAL 
9830583960

asitrdeb@rediffmail.com 
Dr Vaibhav Choudhary  Meditrina Institute of Medical Sciences, Nagpur  Department of Medical Oncology,Meditrina Institute of Medical Sciences S278 Central Bazar Road Ramdaspeth Nagpur Maharashtra 440010
Nagpur
MAHARASHTRA 
9833621049

dr.vaibhav155@gmail.com 
Dr Ananda Selvakumar Pandy  Meenakshi Mission Hospital & Research Centre  "Department of Clinical Research, 1st floor, Oncology Department, Meenakshi Mission Hospital & Research Centre, Lake Area, Melur Main Rd, Madurai - 625107, Tamil Nadu, India. "
Madurai
TAMIL NADU 
9894333759

drask81@yahoo.co.in 
Dr Venkateshan Sreenivasan  MIOT International Hospitals  4/112 Mount Poonamalle Road Sathya Nagar Manapakkam Chennai 600089 Tamil Nadu India
Chennai
TAMIL NADU 
9841022366

vsrinivasan09@gmail.com 
Dr R Srikanth   MNJ Institute of Oncology & Regional Cancer Center  Department of Oncology,MNJ Institute if oncology & Regional Cancer Centre Red Hills Hyderabad 500004
Hyderabad
TELANGANA 
9849009958

srikanthsapthagiri@yahoo.com 
Dr Nalini Kilara  MS Ramaiah Medical College & Hospital  Department of clinical research,1st floor,MS Ramaiah Medical College & Hospitals MS Ramaiah Nagar MSRIT POST Bangalore 560054
Bangalore
KARNATAKA 
9845089482

drnalini.msr@gmail.com 
Dr Mujtaba Ali  Mythri Hospital  Mythri Hospital Opp Pillar No 81, 3rd floor , Room No.314 Pvnr Expressway Inner Ring Rd, Maruthi Nagar Mehdipatnam Hyderabad Telangana 500008
Hyderabad
TELANGANA 
9246244588

ccr.drmujtaba@gmail.com 
Dr Niharika Roy   Netaji Subhas Chandra Bose Cancer Hospital   Department of clinical research, 2nd floor Netaji Subhas Chandra Bose Cancer Hospital 3081 Nayabad Main Rd New Garia Pancha Sayar Kolkata West Bengal 700094
Kolkata
WEST BENGAL 
07612370951

nscbcri2017@gmail.com 
Dr Srikrishna Mandal  Nil Ratan Sircar Medical College Kolkata  Department of Radiotherapy,Nil Ratan Sircar Medical College and Hospital, 138 AJC Bose Road,Kolkata, West Bengal 700014,
Kolkata
WEST BENGAL 
9830648931

mandal_Srikrishna@rediffmail.com 
Dr Dhruv Mehta  Nirmal Hospitals Pvt Ltd  Department of Medical oncology,Nirmal Hospitals Pvt Ltd, Clinical research department, 5th floor, 2/1423/8/6, Sagrampura Ring Road Surat 395002 Gujarat India
Surat
GUJARAT 
9727053929

dr.dhruv.mehta14@gmail.com 
Dr Minish Jain   Noble Hospital Pvt LTd  Department of Clinical research, Noble Annex Hospital, 153, Magarpatta City Road, Hadapsar, Pune-411013, Maharashtra, India
Pune
MAHARASHTRA 
9823133390

minishjain009@gmail.com 
Dr Amit Kumar Dutta  North East Cancer Hospital and Research Institute  North East Cancer Hospital and Research Institute 11th Mile G.S Road Amerigog Jorabat Assam 781023
Kamrup
ASSAM 
8723834334

Duttanechri@gmail.com 
Dr Rachan Shetty SK  OMEGA Hospital   Department of oncology,Omega Hospital Mahaveer Circle Kankanady Mangalore Karnataka 575002
Dakshina Kannada
KARNATAKA 
08242430000

drrachanshetty.medoncology@gmail.com 
Dr Rakesh Neve   PDEAS Ayurved Rugnalaya and Sterling Multispeciality Hospital  Department of Clinical research, PDEAS Ayurved Rugnalaya and Sterling Multispecialty Hospital, Sec # 27, Near Bhel Chowk, Pradhikaran, Nigdi, Pune-411044, Maharashtra , India
Pune
MAHARASHTRA 
9881143140

rakesh.neve23@gmail.com 
Dr Budhi Singh Yadav  PGIMER Chandigarh  EthicsCare Clinical Research Services Pvt ltd. Building no 37, 1st floor, lal kothi wali gali, Near arya hotel and mohan medical, Adarsh Nagar, Naya Gaon, Chandigarh- 160103
Chandigarh
CHANDIGARH 
7087008103

drbudhi@gmail.com 
Dr Shriram Khane  Rashtra Sant Tukdoji Regional Cancer Hospital & Research Centre Nagpur  Department of Medical Oncology,Rashtra Sant Tukdoji Regional Cancer Hospital & Research Centre Department Clinical Research Tukdoji Chowk Manewada Road Nagpur 440027
Nagpur
MAHARASHTRA 
9823012851

shriramkane@gmail.com 
Dr Abhishek Basu  RG Kar Medical College  Department of Radiotherapy,Near OPD gate, 1st floor, Clinical research room (Library room),R.G. Kar Medical College and Hospital, 1, Khudiram Bose Sarani, Kolkata -700004, West Bengal
Kolkata
WEST BENGAL 
9830303459

drabhishekbasu@yahoo.com 
Dr Aniket Thoke   Sanjeevani CBCC USA Cancer Hospital  Sanjeevani CBCC USA Cancer Hospital Department of Clinical research, 1st Floor In front of Jain Mandir Dawada Colony Pachpedi Naka, Raipur 492001 Chhattisgarh
Raipur
CHHATTISGARH 
9829934770

drthoke@gmail.com 
Dr Anita Ramesh  Saveetha Medical College Hospital  Department of Medical Oncology, ground floor Saveetha Medical College and Hospital Saveetha Nagar Thandalam, Chennai Tamil Nadu 602105
Chennai
TAMIL NADU 
9840758567

clinicaltrials.smc@saveetha.com 
Dr Shailesh Arjun Bondarde   Shatabdi Super Specialty Hospital Nashik  Clinical research department, room no.27& 28,Shatabdi Hospital Suyojit city centre opp Mahamarg bus stop Mumbai Naka Nashik 422005 Maharashtra India.
Nashik
MAHARASHTRA 
91-9822012427

shaileshbondarde1971@gmail.com 
Dr Pinakin Patel  SMS Medical College & Hospital  SMS Medical College and Hospital Dept of Surgical Oncology SMS Hospital Room No 101 First Floor, Onco Surgical OT JLN Marg, Jaipur 302004
Jaipur
RAJASTHAN 
9414076855

drpinakinp@gmail.com 
Dr Ghanashyam Biswas  Sparsh Hospitals & Critical Care Private Limited  Department of Medical oncology,Sparsh Hospitals & Critical Care Private Limited Bhubaneswar Odisha 751007
Khordha
ORISSA 
9957500878

drgbiswas@gmail.com 
Dr Anil Goel  SSG Hospital   Department of Radiation Oncology, Department of Clinical Research SSG hospital & Medical College Jail Road, Vadodara 390001 Gujarat, India
Vadodara
GUJARAT 
9227132025

goelanil36@Yahoo.com 
Dr P Venkata Sushma  St Theresas Hospital  "Dept. of clinical Research, Ist floor, Krupa ward St. Theresa’s Hospital,Erragadda Sanath Nagar, Hyderabad-500018, Telangana State, India. "
Hyderabad
TELANGANA 
9701450181

sushmapv@yahoo.com 
Dr Joydeep Ghosh  Tata Medical Center Kolkata  Department of Medical oncology, 1st floor Tata Medical Center, Kolkata 14 MAR E-W DH Block Newtown Action Area I Newtown Kolkata West Bengal 700160
Kolkata
WEST BENGAL 
91678774217

DrJoydeep.ghosh@tmckolkata.com 
Dr Sushmita Rath  Tata Memorial Hospital Mumbai  Tata Memorial Hospital Mumbai Department of Medical Oncology R.N.119 11th Floor Homi Bhabha Block Dr. Ernest Borges Marg,Parel,Mumbai 400012
Mumbai
MAHARASHTRA 
9869154396

sushmitarath73@gmail.com 
Dr Tushar Mule  UNITED CIIGMA Institute of Medical Sciences  UNITED CIIGMA HOSPITAL, plot no 6, 7 , Room 6th floor, clinical research department,Dargah Road Shahnoorwadi, Aurangabad 431005 Maharashtra India
Aurangabad
MAHARASHTRA 
9820493558

drtusharmule22985@gmail.com 
Dr SP Kataria  Vardman Mahavir Medical College & Safdarjung Hospital  Oncology ground floor, Room no 2 Ministry of Health & Family Welfare Govt of India New Delhi - 110029 India
New Delhi
DELHI 
9868818541

spkataria@gmail.com 
Dr Ashay Prasad Karpe   Vijay Vallabh Hospital  Tirupati NagarRd Banjara Hotel Phase 1 Virar West Maharastra 401303
Thane
MAHARASHTRA 
9029083054

shayoncology@gmail.com 
Dr Nikhil S Ghadyalpatil  Yashoda Hospital   Yashoda Hospitals, Block B, 3rd floor, room no.304, Raj Bhavan Rd Matha Nagar Somajiguda Hyderabad Telangana 500082
Hyderabad
TELANGANA 
80088037474

Nikhilghadyalpatil@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 62  
Name of Committee  Approval Status 
Institutional Ethics Committee for Human Research (IECHR)  Submittted/Under Review 
Acharya Harihar Regional Cancer Centre , Administartion Block,1st floor, Medical Road, Mangalabag, Cuttack-753007  Submittted/Under Review 
Apollo Glenagles Hospital, Kolkata  Submittted/Under Review 
Artemis Hospitals, Secttor -51, Gurugram, Haryana 122001  Approved 
Central India Cancer Research Institute, 11 , Shankar Nagar, West High Court Road, Nagpur-440010  Approved 
Chittaranjan Cancer Hospital, SP Mukherjee Road, Kolkata, 700026  Submittted/Under Review 
Dr B L Kapur Memorial Hospital Ethics Committee  Approved 
Ethics Committee GBH Memorial Cancer Hospital  Submittted/Under Review 
Ethics Committee J K Cancer Institute  Approved 
Ethics committee Kodlikeri Memorial Hospital and Group of CIIGMA Hospitals (ECKMH GCH)   Approved 
Ethics Committee Meditrina Institute of Medical Sciences  Approved 
Ethics Committee MS Ramaiah Medical College & Hospitals  Submittted/Under Review 
Ethics Committee NRS Medical College Kolkata  Submittted/Under Review 
Ethics committee ST Theresas Hospital  Approved 
Ethics Committee Sterling Hospital  Submittted/Under Review 
Ethics Committee, Kolhapur Cancer Center  Approved 
Ethics Committee, Sanjeevani Cancer Hospital  Submittted/Under Review 
Ganadhipati Purushottam Shekhawati Hospital Research Centre, Fourth Floor, Opp Time Square, Central Spine, Vidhya dhar Nagar, Jaipur, Rajasthan  Approved 
HCG panda curie cancer hospital, Survey Plot No.236(P)Cuttack, Odisha 753051  Submittted/Under Review 
IEC Saveetha Medical College Hospital  Approved 
Institutional Ethics Committee (IEC) GMC Nagpur  Submittted/Under Review 
Institutional Ethics Committee (IEC) Institute of Medical Sciences (IMS) & SUM Hospital  Submittted/Under Review 
Institutional Ethics Committee All India Institute of Medical Sciences Bhubaneshwar  Submittted/Under Review 
Institutional Ethics Committee – R G KAR MEDICAL COLLEGE  Submittted/Under Review 
Institutional Ethics Committee Basavatarakam Indo American Cancer Hospital & Research Institute  Approved 
Institutional Ethics Committee Deenanath Mangeshkar Hospital and Research Centre  Submittted/Under Review 
Institutional Ethics Committee Deep Hospital   Approved 
Institutional Ethics Committee GMC Aurangabad  Submittted/Under Review 
Institutional Ethics Committee Gurushree Hi Tech Multi Speciality Hospital  Approved 
Institutional Ethics committee HCG Curie City Cancer Centre  Approved 
Institutional Ethics Committee HCG Pinnacle oncology Pvt Ltd  Submittted/Under Review 
Institutional Ethics Committee King Georges Medical University  Approved 
Institutional Ethics Committee Mahatma Gandhi Cancer Hospital and Research Institute  Approved 
Institutional Ethics committee MAULANA AZAD MEDICAL COLLEGE  Submittted/Under Review 
Institutional Ethics Committee Medical College Kolkata  Submittted/Under Review 
Institutional Ethics Committee MMHRC  Approved 
Institutional Ethics Committee Netaji Subhash Chandra Bose Cancer Research Institute  Submittted/Under Review 
Institutional Ethics Committee Noble Hospital  Approved 
Institutional Ethics committee PGIMER  Approved 
Institutional Ethics Committee Rashtra Sant Tukdoji Regional Cancer Hospital & Research Centre  Approved 
Institutional Ethics Committee SMS Medical College and Hospital  Submittted/Under Review 
Institutional Ethics Committee Sparsh Hospital  Approved 
Institutional Ethics Committee Vardhaman Mahavir Medical College & Safdarjung Hospital  Submittted/Under Review 
Institutional Ethics Committee, All India Institute of Medical Sciences,  Submittted/Under Review 
Institutional Review Board Tata Medical Center  Approved 
Kingsway Hospital Ethics Committee  Approved 
Kiran hospital Ethics Committee   Approved 
Krupamayi Hospitals, Akshay Opp. Youth Hostel Near Baba Petrol Pump, Aurangabad, Maharashtra-431001 India  Approved 
Lokmanya Medical Research Centre, Lokmanya Hospital. 314/B Telco Road, Chinchwad Pune , Maharastra-411033 India  Submittted/Under Review 
MAHE Ethics Committee  Approved 
Manavata Clinical Research Institute Ethics Committee  Approved 
Masina Hospital, Sant Savata Mali Marg, Cemetery, Naralwadi, Byculla, Mumbai, Maharashtra 400027  Submittted/Under Review 
MIOT International Hospital, No. 4/112 Mount Ponnamalle Road, Chennai-600089, Tamilnadu  Submittted/Under Review 
MNJ Institute of Oncology & Regional Cancer Centre Ethics Committee  Approved 
Mythri Hospital Mehdipatnam Ethics Committee  Approved 
Nirmal Hospital Ethics Committee  Submittted/Under Review 
NORTH EASTERN CENCER TRUST  Approved 
Omega Ethics Committee  Submittted/Under Review 
Shatabdi hospital Ethics committee  Submittted/Under Review 
TMH Institutional Ethics Committee  Submittted/Under Review 
Vijay Vallabh Hospital & Medical Research Center, Room No.406, 4th Floor, Plot no.423, Tirupati Nagar ,Virar (W)- 401303, Maharashtra  Submittted/Under Review 
Yashoda Academy of Medical Education and Research, Yashoda Hospitals  Submittted/Under Review 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  C798||Secondary malignant neoplasm of other specified sites,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  BP 02 (Trastuzumab) Strength 150 mg powder for concentrate for solution for infusion   Induction Phase: 8 mg/ kg of Trastuzumab and Docetaxel 75mg/m2 in Cycle 1 and 6 mg/kg Trastuzumab + Docetaxel 75mg/m2 for subsequent cycles (Cycle 2-8) will be administered. Maintenance Phase: During maintenance phase, maintenance dose 6mg/kg Trastuzumab for subsequent cycles (cycle 9-cycle 32) will be administered 
Comparator Agent  Herceptin®-EU Strength 150 mg powder for concentrate for solution for infusion   Induction Phase: 8 mg/ kg of Trastuzumab and Docetaxel 75mg/m2 in Cycle 1 and 6 mg/kg Trastuzumab + Docetaxel 75mg/m2 for subsequent cycles (Cycle 2-8) will be administered Maintenance Phase:During maintenance phase, maintenance dose 6mg/kg Trastuzumab for subsequent cycles (cycle 9-cycle 32) will be administered 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  75.00 Year(s)
Gender  Female 
Details  General Inclusion Criteria
1. Female patient between 18 to 75 years of age (both inclusive) at the time of screening
2. Signed informed consent obtained prior to initiation of any study specific procedures and treatment as confirmation of the patient’s awareness and willingness to comply with study requirements
Prior current or planned treatment
3. Patient must not have received prior immunotherapy or biological therapy for their disease
4. Patient who have received adjuvant radiotherapy or chemotherapy as part of treatment of EBC are eligible if the last fraction of radiotherapy was administered at least 6 months prior to randomization and last dose of chemotherapy was administered at least 3 months prior to randomization
Cancer Related
5. Locally or recurrent MBC that is not amenable to curative surgery and or radiation
6.Patient with histologically or cytologically confirmed HER2 positive Metastatic Breast Cancer by immunohistochemistry (IHC 3 positive or IHC 2 positive) When the IHC result is equivocal (defined as 2 positive score) patient with a positive FISH
or CISH result at screening
7. Patient with at least one measurable lesion as per Response Evaluation Criteria in Solid Tumors (RECIST) guideline version 1.1 at screening.Tumor lesions greater than equal to 10 mm in long axis by computerized tomography (CT) scan
b.Malignant lymph nodes greater than equal to 15 mm in short axis when assessed by CT scan
8. Patient with Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (both inclusive) at screening.
9. Patient with life expectancy of more than 24 months in the opinion of the investigator
Prior or concomitant conditions or procedures
10. Women of child-bearing potential must be non-lactating and have a negative pregnancy test at screening
11. Patient of childbearing potential, must agree to pregnancy prevention throughout the duration of the study
12.Females must use acceptable and effective methods of contraception such as the following
a) Two barrier methods used together (cervical cap diaphragm contraceptive sponge or vaginal spermicide plus a male or female condom)
b) Absolute sexual abstinence (no sexual intercourse or genital contact with a male partner)
c) Tubal sterilization (tubal ligation performed more than one month before Study Day 1 transcervical tubal occlusion procedure performed more than six months before Study Day 1)
d) Intrauterine Device (IUD)
e) Progestin Implant (that is Implanon or its equivalent)
f) Progestin injection or progestin oral contraceptive pill plus one barrier method (cervical cap diaphragm contraceptive sponge or vaginal spermicide plus a male or female condom)
13. Patient with a normal left ventricular ejection fraction (LVEF) (greater than equal to 55%) at baseline as determined by either 2 dimensional echocardiogram (2 dimensional ECHO) or multiple-gated acquisition (MUGA) scan. If the patient is randomized the same method of LVEF assessment 2 dimensional ECHO or MUGA scan is required to be used throughout the study
14. Prior treatment with hormonal agents or bisphosphonates or Denosumab will be allowed to continue during the study but should not be started after randomization
15. Patient should not have received blood transfusion within 2 weeks prior to randomization
16. Patient with laboratory parameters as per below
a)Renal Function
I) Serum Creatinine smaller than equal to 1 point 5 times multiple of ULN
b)Hepatic Function
I) Serum Bilirubin smaller than equal to 1 point 5 times multiples of ULN
II) bilirubin smaller than equal to 1 multiple of ULN (smaller than 1 multiple ULN if documented
Gilberts disease)
III) AST and/or ALT smaller than 1 point 5 multiples of ULN if alkaline phosphatase
greater than 2 point 5 multiple of ULN

c)Hematology
I) ANC greater than equal to 1500 per μL
II)Platelet count greater than equal to 100000 per μL
III) Hemoglobin greater than equal to 8 point 5 g per dL
17. Patient who has liver metastasis must have adequate organ function defined as
Organ function: bilirubin smaller than equal to 3 multiples of upper limit of normal (ULN)
alkaline phosphatase alanine transaminase and aspartate
transaminase smaller than equal to 5 multiples of ULN


 
 
ExclusionCriteria 
Details  Patients will be excluded from the study if they meet any of the following criteria
General Exclusion Criteria
1. Inability to comply with protocol procedures
2. Participation in another clinical trial or treatment with another investigational agent within 90 days prior to randomization
Prior, current or planned treatment
3.Patient with history of exposure to the following cumulative doses of Anthracyclines during their lifecycle
a)Doxorubicin/ liposomal doxorubicin greater 400 mg per metre square
b)Epirubicin greater 800 mg per metre square
c)Mitoxantronegreater 120 mg per metre square
4. Patient received prior Trastuzumab for adjuvant/ neoadjuvant therapy for breast cancer
5. Patient received any therapy prior for metastatic disease except hormonal therapy
Cancer Related
6. Patient has metastases to Brain and Spinal cord
7. Patient with any other cancer (that is contralateral breast cancer within 5 years prior to screening exception of treated ductal cancer or cervical cancer or basal or squamous cell cancer of skin)
Prior or concomitant conditions or procedures
8. Patient with human immunodeficiency virus, or current or chronic hepatitis B and or hepatitis C infection
9. Patient with history of known severe hypersensitivity reaction to Docetaxel or any of its excipients
10. Patient with an active, severe infection (example tuberculosis sepsis and opportunistic infections)
11. Patient with history of planned major surgery within 4 weeks prior to first dosing
12. Patient with any other medical or psychiatric condition that could compromise study participation
13. Patient with severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy
14. Patient with acute or active chronic infections, which, in the opinion of the Investigator may affect patient safety or participation in the study
Trastuzumab Exclusion Criteria
15 Patient with history of symptomatic chronic heart failure (New York Heart Association [NYHA] Classes II−IV) or serious cardiac arrhythmia requiring treatment
16 Patient with history of myocardial infarction or unstable angina within 6 months prior to enrolment
17 Patient with uncontrolled hypertension as per investigator’s discretion
 
 
Method of Generating Random Sequence   Stratified randomization 
Method of Concealment   Centralized 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
Objective response rate (ORR) at week 24 defined as the proportion of patients with complete response (CR) or partial response (PR) as assessed by Response Evaluation Criteria In Solid Tumours (RECIST) Version 1.1  Week 24 
 
Secondary Outcome  
Outcome  TimePoints 
Time-to-event end-points- Progression Free Survival  Week 100 
overall survival  Week 100 
Incidence nature and severity of adverse events (AE) including adverse drug reactions (ADRs) graded according to CTCAE v 5.0  Week 100 
Incidence of anti-drug (Trastuzumab) antibodies (ADA) including neutralizing antibodies (NAb).  Week 100 
Trough concentrations of BP02 (Trastuzumab) and the reference product  Week 100 
 
Target Sample Size   Total Sample Size="690"
Sample Size from India="640" 
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)
Modification(s)  
23/09/2020 
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="2"
Months="1"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   None 
Brief Summary  

The study has two treatment periods  Induction Phase (Period I) and Maintenance Phase (Period II)

Induction Phase All eligible patients will be centrally randomized in 1:1 fashion through IWRS based on stratification estrogen and progesterone receptor status (positive versus negative) to receive either BP02 (Trastuzumab) in combination with Docetaxel or Herceptin®-EU in combination with Docetaxel every 3 weeks (1 cycle) for a maximum of 8 cycles (24 weeks of combination treatment) after completion of all screening procedures Tumor assessment will be performed at screening and every 6 weeks after initial drug administration. Ctrough sampling will be done for all the patients at pre-determined time points.

Maintenance Phase Patients with complete response partial response or stable disease at week 24 as assessed by RECIST 1.1 Patients will be administered with study drug on day 1 of each of the 24 3-week cycles. Tumor assessment will be performed every 12 weeks counting from cycle 9 until patient is withdrawn from the study or adverse event, unacceptable toxicity withdrawal of consent, or lost to follow-up

ADA assessments laboratory investigations ECG ECOG performance status and 2D ECHO/MUGA tests will be done as specified in both phases Physical examinations vital signs and body weight/ body surface area measurement will be done at all the visits in both phases Concomitant medications recording and adverse events monitoring will be done throughout the induction and maintenance phase 
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