| CTRI Number |
CTRI/2014/11/005208 [Registered on: 19/11/2014] Trial Registered Prospectively |
| Last Modified On: |
09/03/2020 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study to evaluate Efficacy and Safety of CT-P6 in HER2 Positive Early Breast Cancer ( a type of breast cancer) |
|
Scientific Title of Study
|
A Phase 3, Double Blind, Randomized, Parallel Group, Active Controlled Study to Compare the Efficacy and Safety of CT P6 and Herceptin as Neoadjuvant and Adjuvant Treatment in Patients with HER2 Positive Early Breast Cancer |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 2013-004525-84 |
EudraCT |
| CT-P6 3.2 , Version 2.0, including Amendment 1 - 20 Jan 2014 |
Protocol Number |
| NCT02162667 |
ClinicalTrials.gov |
|
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Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
|
| Designation |
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| Affiliation |
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| Address |
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| Phone |
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| Fax |
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| Email |
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Details of Contact Person
Scientific Query
|
| Name |
Arun Sundriyal |
| Designation |
Director - Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
PPD Pharmaceutical Development India Private Limited, Vatika City Point, 11th Floor,
Sector 25, Mehrauli Gurgaon Road
Gurgaon
HARYANA
122002
India |
| Phone |
911244739903 |
| Fax |
911244739999 |
| Email |
Arun.Sundriyal@ppdi.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun Sundriyal |
| Designation |
Director - Clinical Management |
| Affiliation |
PPD Pharmaceutical Development India Private Limited |
| Address |
PPD Pharmaceutical Development India Private Limited, Vatika City Point, 11th Floor,
Sector 25, Mehrauli Gurgaon Road
Gurgaon
HARYANA
122002
India |
| Phone |
911244739903 |
| Fax |
911244739999 |
| Email |
Arun.Sundriyal@ppdi.com |
|
|
Source of Monetary or Material Support
|
| CELLTRION Inc,23, Academy-ro,
Yeonsu-gu, Incheon,
406-840, South Korea
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Primary Sponsor
|
| Name |
CELLTRION Inc |
| Address |
23, Academy-ro,
Yeonsu-gu, Incheon,
406-840, South Korea
|
| Type of Sponsor |
Pharmaceutical industry-Global |
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Details of Secondary Sponsor
|
| Name |
Address |
| PPD Pharmaceutical Development India Private Limited |
01-Dynasty-B Wing, Kanakia Spaces, Andheri - Kurla Road , Andheri (E), Mumbai 400 059, India. |
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Countries of Recruitment
|
Argentina
Belarus
Brazil
Chile
France
Georgia
Greece
Hungary
India
Italy
Latvia
Mexico
Peru
Philippines
Poland
Portugal
Romania
Russian Federation
Serbia
Spain
Ukraine
Bosnia and Herzegovina
Croatia
Ecuador
Republic of Korea
South Africa
Taiwan
Thailand
Turkey |
Sites of Study
Modification(s)
|
| No of Sites = 12 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Prabrajya Narayan Mohapatra |
Apollo Gleneagles Hospitals Kolkata |
Deparment of Medical Oncology,
58 Canal Circular Road-700054
Kolkata
WEST BENGAL |
919674311610
prabrajya.mohapatra@rediffmail.com |
| Dr Sankar Srinivasan |
Apollo Speciality Hospital |
Department of Medical Oncology,
Padma Complex, No. 320, Anna Salai-600 035
Chennai
TAMIL NADU |
914424331741
srinivasangirija@gmail.com |
| Dr Lalit Mohan Sharma |
Bhagwan Mahaveer Cancer Hospital and Research |
Jawahar Lal Nehru Marg-302017
Jaipur
RAJASTHAN |
919928602244
bmchrcclinicaltrial@gmail.com |
| Dr Prakash Nanasaheb Pandit |
Curie Manavata Cancer Centre |
Opp. Mahamarg Bus Stand, Mumbai Naka-422004
Nashik
MAHARASHTRA |
919969988296
drprakash_tmh@rediffmail.com |
| Dr Pragya Shukla |
Delhi State Cancer Institute |
Dilshad Garden-110095
New Delhi
DELHI |
919560390107
pragyaonco@gmail.com |
| Dr Rajkumar Poovana Nathan |
Dr. Kamakshi Memorial Hospital Pvt Ltd. |
#1, Radial Road, Pallikaranai- 600100
Chennai
TAMIL NADU |
919840228291
rajms99@yahoo.com |
| Dr Ramesh Sarin |
Indraprastha Apollo Hospitals |
Department of Oncology
Sarita Vihar, Delhi - Mathura Road-110076
New Delhi
DELHI |
919810064496
sarinramesh@hotmail.com |
| Dr Pragnya Coca |
Mazumdar Shaw Medical Center,Narayana Hrudayalaya Private Limited |
NH Health City,#258/A, Bommasandra Industrial area,
Hosur Road-560099
Bangalore
KARNATAKA |
918050004989
pragnya.11@gmail.com |
| Dr Chinmay Kumar Basu |
Netaji Subhash Chandra Bose Cancer Research Institute |
16A, Park Lane -700016
Kolkata
WEST BENGAL |
919830114880
ckbose@hotmail.com |
| Dr Sadanand Karandikar |
Ruby Hall Clinic |
Cancer building, 3rd floor
40, Sassoon road-411001
Pune
MAHARASHTRA |
919890281963
skaran44@gmail.com |
| Dr Chandrashekhar Vishwanath Pethe |
Shatabdi Super Speciality Hospital |
Suyojit City Center, Opposite Mahamarg Bus
Stand,Mumbai naka-422005
Nashik
MAHARASHTRA |
918888736446
drcvpethe@gmail.com |
| Dr Seema Gulia |
Tata Memorial Centre |
1. Tata Memorial Centre,Tata Memorial Hospital,Room No. 1109, 11th Floor,Homi Bhabha Block, Dr. E. Borges Marg, Parel– 400012.
2.Tata Memorial Centre, Advanced Centre for Treatment Research and Education in Cancer (ACTREC), Sector-22, Ove Village Kharghar-410210,
Mumbai
MAHARASHTRA |
919920933131
912224177201
drseemagulia10@yahoo.co.in |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 11 |
| Name of Committee |
Approval Status |
| Ethics Committee Netaji Subhash Chandra Bose Cancer Research Institute (Dr. Chinmay Kumar Basu) |
Approved |
| Ethics Committee on Clinical Trials (Dr.Ramesh Sarin) |
Approved |
| Ethics Committee-Apollo Hospitals (Dr.Sankar Srinivasan) |
Approved |
| Institutional Ethics Committee - Apollo Gleneagles Hospitals Kolkata (Dr. Prabrajya Narayan Mohapatra) |
Approved |
| Institutional Ethics Committee- Poona Medical Research Foundation(Dr. Sadanand Karandikar) |
Approved |
| Institutional Ethics Committee-Bhagwan Mahaveer Cancer Hospital and Research Centre(Dr. Lalit Mohan Sharma) |
Approved |
| Institutional Ethics Committee-Dr. Kamakshi Memorial Hospital Pvt Ltd (Dr. Rajkumar Poovana Nathan) |
Approved |
| Manavata Clinical Research Institute Ethics Committee (Dr. Prakash Nanasaheb Pandit) |
Approved |
| Narayana Health Medical Ethics Committee (Dr. Pragnya Coca) |
Approved |
| Shatabdi Hospital Ethics Committee (Dr. Chandrashekhar Vishwanath Pethe) |
Approved |
| Shatabdi Hospital Ethics Committee (Dr. Nitin Laxman Chaudhari) |
Approved |
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Regulatory Clearance Status from DCGI
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Health Condition / Problems Studied
Modification(s)
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| Health Type |
Condition |
| Patients |
HER2-positive Carcinoma of Breast, (1) ICD-10 Condition: C50||Malignant neoplasm of breast, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site, |
|
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Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
CT-P6 (trastuzumab) |
CT-P6 will be administered as IV infusion at 6mg/kg body weight after a loading dose of 8mg/kg body weight, upto 24 weeks (8 cycles) as neoadjuvant and upto 10 cycles as adjuvant treatment.
|
| Comparator Agent |
Herceptin (trastuzumab) |
Herceptin will be administered as IV infusion at 6mg/kg body weight after a loading dose of 8mg/kg body weight, upto 24 weeks (8 cycles) as neoadjuvant and upto 10 cycles as adjuvant treatment.
|
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Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
1.Patient is a female 18 years of age or older.
2.Patient who has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
3.Patient who has histologically confirmed and newly diagnosed breast cancer.
4.Patient who has clinical stage I, II, or IIIa operable breast cancer according to the AJCC Breast Cancer Staging 7th edition.
5.Patient who has HER2 positive status confirmed locally, defined as 3 + score by immunohistochemistry (IHC). |
|
| ExclusionCriteria |
| Details |
1.Patient who has bilateral breast cancer.
2.Patient who is pregnant or lactating.
3.Patient who has received prior treatment for breast cancer, including chemotherapy, biologic therapy, hormone therapy, immunotherapy, radiation or surgery, including any prior therapy with anthracyclines.
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Method of Generating Random Sequence
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Stratified block randomization |
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Method of Concealment
|
Pre-numbered or coded identical Containers |
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Blinding/Masking
|
Participant and Investigator Blinded |
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Primary Outcome
|
| Outcome |
TimePoints |
Equivalence to Herceptin as determined by pCR (pathological Complete Response). Subject who went through Neoadjuvant period completely (24 weeks), will receive surgery within 3-6 weeks after last treatment of neoadjuvant period.
The primary endpoint, Pathological complete response, will be assessed using resected biospecimens collected in breast and axilla during a surgery.
|
After Neo-adjuvant therapy and Surgery (up to 30 weeks) |
|
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Secondary Outcome
|
| Outcome |
TimePoints |
| The secondary objectives of this study are to evaluate additional efficacy parameters (such as ORR) and to obtain additional PK, Pharmacodynamics, safety, and biomarker data. |
For a best overall response of SD, measurements must have met the SD criteria at least once after start of study treatment for a minimum interval of 6 weeks (42 days or more after first administration of study drug). |
|
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Target Sample Size
|
Total Sample Size="532"
Sample Size from India="92"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
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Phase of Trial
|
Phase 3 |
Date of First Enrollment (India)
Modification(s)
|
14/01/2015 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
10/06/2014 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
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Estimated Duration of Trial
|
Years="5"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Closed to Recruitment of Participants |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
Publication Details
Modification(s)
|
Not applicable |
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Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
Modification(s)
|
This is a double-blind, randomized, parallel-group, active-controlled, multicenter, international, prospective Phase 3 study.This is the trial to see the equivalence of CT-P6 and Herceptin determined by pCR (pathological Complete Response) after surgery followed by 8 cycles of Neo-adjuvant therapy. Maximum 10 cycles of adjuvant therapy will be given to patients. |