Study to Compare the Efficacy and Safety of GBR 200 (similar biologic of Trastuzumab) versus Innovator Trastuzumab both when given in combination with Paclitaxel in patients diagnosed with HER2 Positive Metastatic Breast Cancer

Phase 3

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

Registration Number: CTRI/2017/02/007892

Lead Sponsor: Glenmark Pharmaceuticals Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 0

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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