Health Condition 1: null- Metastatic breast cancer
Conditions
Interventions
Intervention1: Non Pegylated Liposomal Doxorubicin (NPLD): In Part A: Intravenous 60 mg/m2 or 70mg/m2 every 3 weeks up to 8 cycles
In Part B: NPLD (70 mg/m2 )or doxorubicin (70 mg/m2 )
Control Interv
Sponsors
Zydus BSV Pharma Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1) Female subjects aged 18 years. 2) Life expectancy of atleast 6 months at the time of enrolment. 3) Histologically confirmed metastatic breast cancer with at least one measurable lesion as determined by RECIST criteria. 4) Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2. 5) No concurrent uncontrolled illness as determined by the investigator. 6) No other malignancies (with the exception of squamous cell carcinoma of the skin treated by surgery). 7) Baseline left ventricular ejection fraction (LVEF) more than 50 % as determined by 2D ECHO. 8) Subjects who have not been previously treated for advanced metastatic disease. Prior adjuvant and neo-adjuvant chemotherapy is allowed if 1 year has elapsed since discontinuation of treatment. 9) If previously treated with doxorubicin and/or epirubicin in past, total lifetime exposure shall not be more than 300mg/m2 of doxorubicin or 450 mg/m2 of epirubicin. 10) Sufficient hepatic, renal and bone marrow function (Patients with elevated bilirubin and / or elevated ALT/AST will be eligible for inclusion, if reduced liver function was secondary to liver metastasis). a. Serum bilirubin less than / equal to 1.5 x the upper limit of normal (ULN) b. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels less than / equal to 3 x ULN, except in the presence of hepatic metastases, where less than / equal to 5 x ULN is allowed. c. Serum Creatinine less than / equal to 1.5 times the ULN. d. Absolute neutrophil count greater than / equal to 1.5 x 109/L e. Platelet count greater than / equal to 100 x 109/L f. Haemoglobin greater than / equal to 9 g/dL 11) Patient ensuring geographical accessibility to the participating oncology centre and compliance with treatment and scheduled follow-up. 12) If the subject is of childbearing potential, she must have a negative pregnancy test at screening. (Women with childbearing potential will be advised to take adequate precautions to prevent pregnancy) 13) Subject or her legal representative has signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) Pregnancy or breast-feeding. 2) Woman with childbearing potential with inadequate protection against pregnancy. 3) Any other uncontrolled illness. 4) Other conditions such as benign breast cancer and malignancies (with the exception of squamous cell carcinoma of the skin treated by surgery); 5) Subject treated for advanced breast cancer in past one year. 6) Presence of active infections. 7) Presence of cerebral metastases. 8) Clinically insufficient renal, hepatic and bone marrow function. 9) Cardiac diseases including congestive heart failure, atrial or ventricular arrhythmia. 10) Early breast cancer with non-measurable lesion, rising of tumour markers, lymphangitic neoplasm or sclerosing bone lesions as the only sign of disease. 11) Patient with known or suspected Allergy to the Investigational product, other Anthracyclines, egg or egg products or any agent given in association with this trial. 12) Patients who have participated in another clinical trial study during the past 30 days or who are likely to simultaneously participate in another clinical study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| In Part A: The primary objective of this study is to compare the overall response rate (ORR) to 60 or 70 mg/m2 of NPLD in target lesions of MBC using RECIST criteria. In Part B: The primary objective of this study is to assess the overall response rate (ORR) to NPLD (70 mg/m2)(NUDOXA)in target lesions of MBC using RECIST criteria. Timepoint: The evaluation will be done on visit 1, 4, 6, 8 and 10 | — |
Secondary
| Measure | Time frame |
|---|---|
| Part A:The secondary objectives are to evaluate the overall response rate to NPLD (60 and 70mg/m2) in non-target lesions of MBC using RECIST criteria.Part B:To evaluate the overall response rate to NPLD(70mg/m2) as compared to doxorubicin 70 mg/m2 in non-target lesions of MBC using the RECIST criteria.Timepoint: The evaluation will be done on visit 1, 4, 6, 8 and 10 for secondary objectives. | — |
Countries
India
Contacts
Public ContactDrRHJani
Cadila Healthcare Limited
Outcome results
None listed