Safety and Effectiveness assessment of Trastuzumab emtansine of Zydus Lifesciences Ltd for the treatment of early breast cancer in Indian patients.

Not Applicable

Recruiting

• Conditions: Malignant neoplasm of breast of unspecified site,

• Registration Number: CTRI/2023/04/051319
• Lead Sponsor: Zydus Lifesciences Limited

Brief Summary

This is aProspective, Multicenter, Non-Interventional, Real-World Study to Evaluate theSafety, Adherence to Therapy, and Effectiveness of a T-DM1 Antibody-DrugConjugate Biosimilar (Zydus Lifesciences Ltd) patients with HER2-Positive EarlyBreast Cancer.

Detailed Description

Not available

Study Timeline

• Study Start: 2023-04-17
• Last Update Posted: 2024-12-18

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Female
• Target Recruitment: 300

Inclusion Criteria

• Female with age ≥18 years 2.
• HER2-positive breast cancer: Positivity will be based on pretreatment biopsy and defined as an immunohistochemistry (IHC) score of 3+ and/or positive by in situ hybridization (ISH), prospectively confirmed by a hospital/laboratory before study enrollment 3.
• Histologically confirmed invasive breast carcinoma 4.
• Clinical stage at presentation: T1–4, N0–3, M0 (Note: Patients with T1a/bN0 tumors will not be eligible) 5.
• Completion of preoperative systemic treatment consisting of at least 4 cycles, including at least 9 weeks of trastuzumab 6.
• Adequate excision: surgical removal of all clinically evident disease in the breast and lymph nodes 7.
• Pathologic evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy 8.
• Known hormone receptor status (either ER and/or PR of the primary tumor) 9.
• Life expectancy ≥6 months 11.
• Confirmed non-pregnant status for premenopausal women including women who have had a tubal ligation and for women less than 12 months after the onset of menopause.

Exclusion Criteria

• Stage IV (metastatic) breast cancer 2.
• History of any prior (ipsi- or contralateral) 3.
• breast cancer except lobular carcinoma in situ (LCIS) 4.
• Evidence of clinically evident gross residual or recurrent disease following preoperative therapy and surgery 5.
• Progressive disease (PD) during preoperative therapy 6.
• Treatment with any anti-cancer investigational drug within 28 days before commencing study treatment 7.
• History of other malignancy within the last 5 years except for appropriately treated carcinoma in situ (CIS) of the cervix, non-melanoma skin carcinoma, stage I uterine cancer, or other non-breast malignancies with an outcome similar to those mentioned above 8.
• Patients for whom radiotherapy would be recommended for breast cancer treatment but for whom it is contraindicated because of medical reasons 9.
• Prior treatment with trastuzumab emtansine 10.
• For female patients, current pregnancy and/or lactation 11.
• Major surgical procedure unrelated to breast cancer or significant traumatic injury within approximately 28 days before enrollment or anticipation of the need for major surgery during the course of study treatment 12.
• History of intolerance, including grade 3 to 4 infusion reaction or hypersensitivity to trastuzumab or murine proteins.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the safety of UJVIRA in HER2-positive EBC patients	Follow up at 1 year and at 2 year

Secondary Outcome Measures

Name	Time	Method
• To evaluate adherence to UJVIRA therapy	• To evaluate the effectiveness of UJVIRA in terms of invasive disease-free survival (IDFS) in HER2-positive EBC patients

Trial Locations

Locations (10)

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

Aster CMI Hospital Bangalore; 🇮🇳 Bangalore, KARNATAKA, India

Basavatarakam Indo American Cancer Hospital and Research Institute; 🇮🇳 Hyderabad, TELANGANA, India

Cytecare Hospitals Pvt. Ltd.; 🇮🇳 Bangalore, KARNATAKA, India

Kokilaben Dhirubhai Ambani Hospital & Medical Research Institute; 🇮🇳 Mumbai, MAHARASHTRA, India

Max Super Speciality Hospital, saket (East Block - A Unit of Devki Devi Foundation); 🇮🇳 Delhi, DELHI, India

Mumbai Oncocare Centre (Unit of Cellcure Cancer Centre Pvt Ltd); 🇮🇳 Mumbai, MAHARASHTRA, India

Tata Medical Center; 🇮🇳 Kolkata, WEST BENGAL, India

The Gujarat Cancer and Research Institute; 🇮🇳 Ahmadabad, GUJARAT, India

Zydus Cancer Centre, A unit of Zydus Hospital and Research Pvt. Ltd.; 🇮🇳 Ahmadabad, GUJARAT, India

All India Institute of Medical Sciences

🇮🇳Delhi, DELHI, India

Dr Ajay Gogia

Principal investigator

9013000642

ajaygogia@gmail.com