To evaluate safety and efficacy of Trastuzumab, (Manufactured by Intas) in comparison with Reference Biologic (Trastuzumab, Marketed by Roche) in the patients with Metastatic Breast Cancer.

A prospective, multicentric, randomized, open label, parallel group, comparative, two arms, safety, efficacy and pharmacokinetic study of Trastuzumab, (Manufactured by Intas Pharmaceuticals Limited, Biopharma Division, Ahmedabad, India) in comparison with Reference Biologic (Trastuzumab, Marketed by Roche) in the patients with HER2-Overexpressing Metastatic Breast Cancer. - NA

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2015/09/006168

Enrollment

108

Registered

2015-09-08

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: Trastuzumab (Intas): Dose-8 mg/kg, 6 mg/kg, Frequency-Multiple dose, Mode of Administration-IV, Duration of treatment- 6 cycles Control Intervention1: Trastuzumab (Roche): Dose-8 mg/kg,

Eligibility

Inclusion criteria

Inclusion criteria: 1. The patient willing to give informed consent to participate in the study before initiating any study related procedures 2. Female >=18 years and 3. Women with histologically/cytologically confirmed HER2 (human epidermal growth factor receptor 2)-Overexpressing metastatic breast cancer. 4. Patients who are eligible for taxanes and Trastuzumab as per opinion of PI. 5. Patient must have an adequate bone marrow, renal, cardiac and hepatic function.

Exclusion criteria

Exclusion criteria: 1. Patient with severely immunocompromised state. 2. Chronic treatment with systemic steroids or another immunosuppressive agent. 3. Clinically significant medical condition that, in opinion of the investigator, might place the patient at unacceptable risk for participation in this study 4. Patients with an active, severe infection (e.g., tuberculosis, sepsis and opportunistic infections). 5. Any malignancy in the last 2 years other than breast cancer except skin cancer or carcinoma in situ of the cervix

Design outcomes

Primary

Measure	Time frame
â?¢ To evaluate the efficacy of Trastuzumab (Manufactured by Intas Pharmaceuticals Limited, Biopharma Division, Ahmedabad, India) against Reference Biologic, Trastuzumab (Marketed by Roche) in the patients with HER2-Overexpressing Metastatic Breast Cancer.Timepoint: At end of the 6 cycles	—

Secondary

Measure	Time frame
â?¢ To compare the pharmacokinetics â?¢ To monitor the safety and tolerability of the patients exposed to the investigational medicinal product.Timepoint: At end of the 6 cycles	—

Countries

India

Contacts

Public ContactDr Ankit Ranpura

Lambda Therapeutic Research Ltd

ankitranpura@lambda-cro.com07940202074

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026