Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: GBR 200 (Similar biologic of Trastuzumab): A loading dose of 8 mg/kg of body weight followed by maintenance dose of 6 mg/kg of body weight for subsequent 5 cycles (Cycle 2 to Cycle 6) a
Sponsors
Glenmark Pharmaceuticals Ltd
Alkem Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. Female patients aged 18 years to 65 years of age (both inclusive) at the time of signing the ICF 2. Histologically confirmed diagnosis of breast cancer 3. Presence of metastatic disease as per Tumor Node Metastasis staging at screening 4. Has at least 1 measurable target lesion (tumor/lymph node) as per RECIST version 1.1 at screening 5. HER2 overexpression confirmed by immunohistochemistry (IHC) (IHC3+ or IHC2+ with positive fluorescent in situ hybridization [FISH] test result) at screening 6. Eastern cooperative oncology group (ECOG) status 0 to 2 at screening
Exclusion criteria
Exclusion criteria: 1. History of known severe hypersensitivity reaction to Trastuzumab or Paclitaxel or any of its excipients 2. Prior systemic therapy for metastatic disease, including cytotoxic chemotherapy, or previous anticancer therapy with signal transduction inhibitors (e.g. Lapatinib), biological drugs (e.g. Trastuzumab and Bevacizumab), experimental drugs (not approved for breast cancer therapy, anticancer drugs (except hormonal therapy) 3. Prior Trastuzumab or Taxane for adjuvant/neoadjuvant therapy for breast cancer within 12 months prior to randomization 4. Has received cumulative doses of anthracycline, exceeding 360 mg/m2 of BSA for doxorubicin, 720 mg/m2 of BSA for epirubicin, 120 mg/m2 of BSA for mitoxantrone, and 90 mg/m2 of BSA for idarubicin. 5. Has metastasis to central nervous system 6. Has undergone any prior mediastinal irradiation (except internal mammary node irradiation) for the present breast cancer 7. Has undergone surgery or radiation therapy within 4 weeks prior to randomization 8. Positive serology for Human Immunodeficiency Virus (HIV), Hepatitis B virus (HBV) and Hepatitis C virus (HCV) at screening 9. Patients who are pregnant or nursing
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients achieving ORR (complete response [CR] or partial response [PR] per response evaluation criteria in solid tumors (RECIST) version 1.1) at the EOS.Timepoint: 18 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| PK parameters (Cmax, Ctrough, AUC0-t and AUC(0-tau)ss) of GBR 200 versus Innovator TrastuzumabTimepoint: Weeks 0, 9, 12, and 15;Presence of anti-trastuzumab antibody across both treatment groupsTimepoint: 18 weeks;Treatment emergent adverse events (TEAEs) and alteration of the laboratory investigations during the studyTimepoint: 18 Weeks | — |
Countries
India
Contacts
Public ContactDr Akhilesh D Sharma
Glenmark Pharmaceuticals Limited
Outcome results
None listed