Safety and efficacy Assessment of Trastuzumab emtansine of Cadila Healthcare Ltd in comparison with Reference drug(Trastuzumab emtansine) for the treatment of metastatic breast cancer

Phase 3

Completed

• Conditions: HER2- positive, metastatic breast cancer

• Registration Number: CTRI/2018/07/014881
• Lead Sponsor: Cadila Healthcare Ltd

Brief Summary

This is Prospective,Randomized, Multicenter, Comparative, Open-label, Parallel study to evaluatethe Efficacy, Safety and Pharmacokinetics of Test-Trastuzumab Emtansine (ZRC-3256;CadilaHealthcare Ltd) and Reference-Trastuzumab Emtansine(Kadcyla®, RocheProducts (India) Pvt. Ltd.) in HER2- Positive Metastatic Breast Cancer Patients.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-05-15
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 168

Inclusion Criteria

• 1.Female subjects of age 18 to 65 years (both inclusive).
• 2.Subject with pathologically (histologically or cytologically) confirmed, uni-dimensionally measurable invasive metastatic breast cancer.
• 3.Subjects with a strong HER-2 over-expression as described by a 3+ score by immunohistochemistry (IHC) or a positive fluorescence in-situ hybridization (FISH).
• 4.For the treatment of subjects with HER2-positive, metastatic breast cancer who previously received trastuzumab and a taxane, separately or in combination.
• Subject should have either: • Received prior therapy for metastatic disease, or • Developed disease recurrence during or within six months of completing adjuvant therapy.
• 5.Subject with Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
• 6.Left ventricular ejection fraction (LVEF) ≥50% by 2 D ECHO.
• 7.Subjects with following laboratory results: • Absolute neutrophil count >1500 cells/mm3 • Platelet count >100,000 cells/mm3 • Hemoglobin ≥9.0 g/Dl • Total bilirubin ≤1.5 upper limit of normal (ULN) • AST, ALT and alkaline phosphatase ≤ 2.5 X ULN.
• 8.Subjects must have recovered from all treatment related toxicities prior to randomization.
• 9.Pregnancy-related inclusions, including: •Subjects with negative serum pregnancy test at trial start •Women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry, for the duration of study participation and till the end of study visit.
• 10.Ability to comply with study and follow – up procedures and provide written informed consent.
• 11.Patient with life expectancy of minimum of 7 months at screening.

Exclusion Criteria

• 1.Subject with history of Trastuzumab emtansine treatment.
• 2.Current severe, uncontrolled systemic disease (e.g., clinically significant cardiovascular, pulmonary, or metabolic disease).
• 3.History of symptomatic chronic heart failure (New York Heart Association [NYHA] Classes II-IV) or serious cardiac arrhythmia requiring treatment.
• 4.Current uncontrolled hypertension (systolic blood pressure >150 mmHg and/or diastolic blood pressure >100 mmHg), or unstable angina.
• 5.Pregnancy or lactation.
• 6.Current known active infection with HIV, hepatitis B virus, or hepatitis C virus.
• 7.Have a history of hypersensitivity to the Trastuzumab emtansine or to drugs with similar chemical structures, or to any of the excipients, or to murine proteins.
• 8.Have any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
• 9.Any chemotherapy, hormonal therapy, radiotherapy or surgery for the treatment of breast cancer within 3 weeks of screening.
• 10.Have any concurrent disease or condition that, in the opinion of the investigator, would make the subject unsuitable for participation in the study.
• 11.Have any other medical or psychiatric condition that could compromise study participation.
• 12.Current clinical or radiographic evidence of Central nervous metastates.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To compare the overall response rate (ORR) following administration of ZRC-3256 (Cadila Healthcare Limited) and Kadcyla® in patients with metastatic breast cancer based on Response Evaluation Criteria in Solid Tumors (RECIST, Version 1.1) achieved at end of 24 weeks.	Timeframe: Week 0 (baseline), week 24 (visit 15)

Secondary Outcome Measures

Name	Time	Method
1.To compare the pharmacokinetic parameters (Cmax, AUC0-t )	2.To compare the incidence and titres of Anti-Drug Antibodies at the end of 12 weeks (visit 11) and 24 weeks treatment (visit 15)

Trial Locations

Locations (34)

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

All India Institute of Medical Sciences (AIIMS); 🇮🇳 Delhi, DELHI, India

Amrita Institute of Medical Sciences; 🇮🇳 Ernakulam, KERALA, India

Apex Hospital Pvt. Ltd; 🇮🇳 Jaipur, RAJASTHAN, India

Batra Cancer Centre; 🇮🇳 Delhi, DELHI, India

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

Bhakti Vedanta Hospital and Research Institute; 🇮🇳 Thane, MAHARASHTRA, India

Dayanand medical college & Hospital; 🇮🇳 Ludhiana, PUNJAB, India

Deenanath Mangeshkar Hospital and Research Center; 🇮🇳 Pune, MAHARASHTRA, India

ERODE CANCER CENTRE; 🇮🇳 Erode, TAMIL NADU, India

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HCG Manavata Cancer Centre

🇮🇳Nashik, MAHARASHTRA, India

Dr Rajnish Nagarkar

Principal investigator

9823061929

drraj@manavatacancercentre.com