Health Condition 1: null- HER2-Positive Metastatic Breast Cancer (MBC)
Conditions
Interventions
Intervention1: DRL_TZ: 4mg/kg loading dose followed by 2mg/kg weekly in combination with paclitaxel 80 mg/m2 weekly for up to 24 weeks or until disease progression, intolerable toxicity or death, whic
Sponsors
Dr Reddys Laboratories Ltd
Manipal Acunova Ltd
Eligibility
Inclusion criteria
Inclusion criteria: • Female patients -18 to 75 years of age. • Histologically or cytologically confirmed metastatic breast cancer. ï?· Metastatic disease, at least M1 as per AJCC TNM classification. ï?· Histopathology is recommended to be performed at local laboratory to confirm the metastatic disease, if no previous reports available. ï?· In case historical reports of histopathology confirming evidence of breast cancer (primary/metastatic) are available, a repeat biopsy is not required. ï?· In case of metastatic lesions such as a solitary metastatic nodule or a solitary lymph node, biopsy must be performed to confirm metastatic breast cancer • Strong HER2-positive status - 3+ score by IHC - to be confirmed at a pre-identified qualified laboratory. • At least one measurable lesion as per RECIST 1.1, in an area/region that has not been irradiated before. • ECOG performance status of 0, 1 or 2. • Life expectancy of more than 3 months in the opinion of the Investigator. • LVEF >= 50% by echocardiography or MUGA
Exclusion criteria
Exclusion criteria: • Male patients with metastatic breast cancer. • H/o prior invasive malignancy, except breast cancer or non-melanoma skin cancer radically resected and non-recurring, at least 1 year prior to randomization. • Breast cancer metastases in central nervous system. • Patients who had received prior chemotherapy, hormonal therapy or radiotherapy for their metastatic disease or any prior taxanes or anti-HER2 therapy are excluded, except: ï?· (neo) adjuvant anthracycline administered 6 months prior to randomization is allowed; ï?· (neo) adjuvant taxanes administered 12 months prior to randomization is allowed ï?· (neo)adjuvant trastuzumab or any other monoclonal antibody administered 12 months prior to randomization is allowed; ï?· Hormonal therapy administered in neo(adjuvant) setting only or as a maintenance therapy after neo(adjuvant) treatment; ï?· Previous radiotherapy in neo (adjuvant) setting only if treatment has ended 6 months prior to randomization, is allowed. • Any cardiac disease (history of and/or active disease); Severe uncontrolled hypertension • Severe dyspnoea at rest due to complications of advanced malignancy or requiring supplementary oxygen therapy • Sensory or motor neuropathy • Acute or active chronic infections which, may affect patient safety or participation in the study • Known hepatitis C virus, hepatitis B virus, HIV infection • Known hypersensitivity/allergy to trastuzumab, paclitaxel or any excipients • Known history of drug/alcohol abuse.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of DRL_TZ with Herceptin® administered weekly in combination with weekly paclitaxel, as first line treatment for HER2-positive MBC, measured in terms of best overall response rate (ORR) as assessed using RECIST 1.1 criteria.Timepoint: 24 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety, Toleribility, Pharmacokinetic and ImmunogenicityTimepoint: Pharmacokinetic parameters: AUC0-t and Cmax following the first dose of trastuzumab calculated by non-compartmental methods, and trough concentrations before the trastuzumab doses administered at weeks 2, 6, 12 and 24. | — |
Countries
India, Russian Federation
Contacts
Public ContactNaveen Reddy
Dr. Reddyâ??s Laboratories Ltd.
Outcome results
None listed