Health Condition 1: null- Female subjects with age 18 to 70-years inclusive, with histologically or cytologically confirmed metastatic breast cancer Health Condition 2: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Paclitaxel nano-dispersion concentrate for injection (PICN): 3 weekly
Cycles till disease progression/ toxicity
Control Intervention1: Marketed Paclitaxel nano-dispersion: 3 weekly
Cycles till disease progression/ toxicity
Sponsors
Sun Pharma Advanced Research Company Ltd
Eligibility
Inclusion criteria
Inclusion criteria: Histologically or cytologically confirmed metastatic breast cancer is candidate for single agent paclitaxel in accordance with standard of care. Female subjects aged 18 to 70 years; Performance status less than or equal to 2 on the ECOG performance scale Estimated life expectancy of at least 12-weeks; Measurable disease as per RECIST Version 1.1; Adequate organ and immune system function as indicated by the laboratory values, obtained ≤ 2 weeks prior to dosing; Subjects must have received prior chemotherapy as adjuvant therapy or for metastatic disease. Any chemotherapy (except palliative bisphosphate therapy for bone pain), major surgery, or irradiation must have been completed at least 4-weeks before enrollment in this study (6-weeks for Mitomycin C or nitrosurea); subjects must have recovered from all toxicities incurred as a result of previous therapy; If subject has received taxanes as adjuvant therapy, she must not have relapsed with breast cancer within 48-weeks of completing adjuvant taxane therapy; Prior hormonal therapy for breast cancer must have been completed at least 2-weeks before enrollment in this study; Women of child bearing potential practicing an acceptable method of birth control or postmenopausal for at least 1 year, surgically sterile with a negative urine pregnancy test; Willing to participate and give written informed consent.
Exclusion criteria
Exclusion criteria: Any malignancy within past 5-years, except non-melanoma skin cancer, cervical intraepithelial neoplasia (CIN), or in situ cervical cancer (CIS); The only evidence of metastasis is lytic or blastic bone lesions or pleural effusion or ascites; Known hypersensitivity to study drugs or its excipients (Cholesteryl sulfate, Caprylic acid, Polyvinylpyrrolidone, Ethanol or Polyethylene glycol); Treatment with any investigational agents within 30-days of study entry; Presence of clinically evident active CNS metastases, including leptomeningial involvement, requiring steroid or radiation therapy; Pre-existing peripheral neuropathy ; Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study; Taxanes received for metastatic breast cancer; Presence of pleural/ascitic fluid
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate safety and efficacy of PICN (Paclitaxel injection concentrate for nanodispersion)Timepoint: After 6 cycles for all patients. | — |
Secondary
| Measure | Time frame |
|---|---|
| PFS (Progression free survival)Timepoint: At the end of study | — |
Countries
India
Contacts
Public ContactDr Mudgal Kothekar MD
Sun Pharma Advanced Research Company Ltd
Outcome results
None listed