Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: FDC of Capecitabine & Cyclophosphamide tablet: Dose: Group 1: 1400+60 mg/day, Group 2: 1800+80 mg/day, Group 3: 2200+100 mg/day, Frequency: Twice,Mode of Administration: Oral, Duration
Sponsors
Intas Pharmaceuticals Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1. The patient willing to give written, signed and dated, informed consent to participate in the study. 2. Female >=18 years and 3. Patient must have histopathologically / cytologically confirmed breast cancer. 4. Have at least one measurable lesion as per the RECIST criteria (version 1.1) 5. Eastern Cooperative Oncology Group (ECOG) performance status 6. Left Ventricular Ejection fraction (LVEF) >= 50% as per Echocardiography (ECHO). 7. Patient must have recovered from any toxic effects of previous chemotherapy or radiotherapy as judged by the Investigator. 8. Previous chemotherapy/radiotherapy should be completed 4 weeks prior to start of IMP administration 9. Patients with life expectancy of at least 6 months. 10. Serum pregnancy test at screening visit and urine pregnancy test at baseline visit must be negative and agreed to use birth control measured throughout study duration. 11. Patient with adequate bone marrow, renal and hepatic function.
Exclusion criteria
Exclusion criteria: 1. Patients with known hypersensitivity to capecitabinecyclophosphamide, any excipients of IMPs or with known DPD deficiency. 2. Concurrent chemotherapy or radiation therapy regimens. 3. Patient with clinically significant cardiac conditions: 4. Known History of drug addiction within last 1 year 5. Any other condition that, in the investigatorâ??s judgment, might increase the risk to the patient or decrease the chance of obtaining satisfactory data needed to achieve the objectives of the study. 6. Patients who are unwilling or unable to follow protocol requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| â?¢ To assess efficacy of FDC of capecitabine and cyclophosphamide in patients with metastatic breast cancer.Timepoint: At end of 6 cycles | — |
Secondary
| Measure | Time frame |
|---|---|
| â?¢ To evaluate pharmacokinetic profile of Capecitabine and cyclophosphamide. â?¢ To evaluate safety of the patients who are exposed to the investigational medicinal products.Timepoint: First 5 days of cycle 1, Throughout study period. | — |
Countries
India
Contacts
Public ContactTapan Shah
Lambda Therapeutic Research Ltd
Outcome results
None listed