A study to evaluate Efficacy and Safety of CT-P6 in HER2 Positive Early Breast Cancer ( a type of breast cancer)

Phase 3

Active, not recruiting

• Conditions: Malignant neoplasm of breast, (2) ICD-10 Condition: C509||Malignant neoplasm of breast of unspecified site,

• Registration Number: CTRI/2014/11/005208
• Lead Sponsor: CELLTRION Inc

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-01-14
• Last Update Posted: 2020-09-03

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Female
• Target Recruitment: 532

Inclusion Criteria

• 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).

Exclusion Criteria

• 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	After Neo-adjuvant therapy and Surgery (up to 30 weeks)
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)

Secondary Outcome Measures

Name	Time	Method
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).

Trial Locations

Locations (12)

Apollo Gleneagles Hospitals Kolkata; 🇮🇳 Kolkata, WEST BENGAL, India

Apollo Speciality Hospital; 🇮🇳 Chennai, TAMIL NADU, India

Bhagwan Mahaveer Cancer Hospital and Research; 🇮🇳 Jaipur, RAJASTHAN, India

Curie Manavata Cancer Centre; 🇮🇳 Nashik, MAHARASHTRA, India

Delhi State Cancer Institute; 🇮🇳 Delhi, DELHI, India

Dr. Kamakshi Memorial Hospital Pvt Ltd.; 🇮🇳 Chennai, TAMIL NADU, India

Indraprastha Apollo Hospitals; 🇮🇳 Delhi, DELHI, India

Mazumdar Shaw Medical Center,Narayana Hrudayalaya Private Limited; 🇮🇳 Bangalore, KARNATAKA, India

Netaji Subhash Chandra Bose Cancer Research Institute; 🇮🇳 Kolkata, WEST BENGAL, India

Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

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Apollo Gleneagles Hospitals Kolkata

🇮🇳Kolkata, WEST BENGAL, India

Dr Prabrajya Narayan Mohapatra

Principal investigator

919674311610

prabrajya.mohapatra@rediffmail.com