A phase III clinical trial of Bmab-200 versus Herceptin, both in combination with Docetaxel in patients with Her2+ Metastatic Breast cancer

Comparative PK, Efficacy, Safety and Immunogenicity evaluation of Bmab-200 versus Herceptin®, both in combination with Docetaxel in patients with Her2+ Metastatic Breast Cancer: A Double Blind, Randomised, Active Control, Parallel assignment, Comparative Phase III, Clinical Trial

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2011/08/001958

Enrollment

132

Registered

2011-08-23

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: null- patients with Her2+ Metastatic Breast cancer

Interventions

Intervention1: Bmab 200: Bmab-200 8 mg/kg IV loading, followed by 6 mg/kg IV maintenance, every 3 weeks for 24 weeks Control Intervention1: Heceptin: Herceptin 8 mg/kg IV loading, followed by 6 mg/kg

Eligibility

Inclusion criteria

Inclusion criteria: ï¿½ Female patients 18 years of age ï¿½ Written and signed informed consent. ï¿½ Have pathologically confirmed metastatic breast cancer, ï¿½ Have a strong Her-2 over-expression.

Exclusion criteria

Exclusion criteria: ? Prior chemotherapy for metastatic breast cancer. ? Has received anti-cancer therapy within 4 weeks prior to randomization. ? Prior treatment with anti-HER2 therapy. ? Any clinical or radiological evidence of severe / uncontrolled cardiovascular disease. ? Normal hematology and serum biochemistry

Design outcomes

Primary

Measure	Time frame
The equivalence of single dose pharmacokinetics between Bmab-200 and HerceptinÂ® in terms of AUC0-t and CmaxTimepoint: 6 months	—

Secondary

Measure	Time frame
1. Overall response rate-ORR over 8 cycles of combination chemotherapy with docetaxel. 2. The multiple-dose pharmacokinetic parameters of Bmab-200 and HerceptinÂ® 3. Safety and immunogenicityTimepoint: 6 months	—

Countries

India

Contacts

Public ContactJayanti Panda

Biocon Limited

Prasanna.ganapathi@biocon.com08028085334

Outcome results

None listed

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