Health Condition 1: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
Intervention1: Metronomic chemotherapy: Name and dose of the drug: MCT Cyclophosphamide (CTX) (50-1000mg) +/- Methotrexate (2.5-100mg), MCT Capecitabine (CAPE) (50-1000mg).
The range of the drugs is m
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: 1) Female patients with age more than equal to 18 years and less than equal to 80 years. 2) Patients with confirmed TNBC from pathological reports, previously treated or not with other drugs for the metastatic disease. 3) Patients with more than equal to 1 measurable lesion according to RECIST 1.1 criteria, ECOG score less than equal to 2 and life expectancy of more than equal to 16 weeks. 4) Patients with adequate bone marrow, hepatic, and renal functions, indicated by haemoglobin more than equal to 10g per L, absolute neutrophil count more than equal to 1.5 billion neutrophils per liter of blood, platelet count more than equal to 100 billion platelets per liter of blood, total serum bilirubin less than 1.5 of upper normal limit (UNL), AST/ALT less than 2.5 of UNL, (less than 3.5 of UNL for liver metastases), or alkaline phosphatase less than 2.5 of UNL (less than 5 of UNL for bone/liver metastases). 5) Evidence of cachexia as judged by one of: a. More than equal to 5 percent of documented weight loss in the previous 6 months. b. A subjective report of weight loss in the previous 6 months and a recorded BMI less than 20 kilograms per square meter. c. Ongoing documented weight loss of at least 1 kg in the week prior to day 0; or 1.25 kg in the 2 weeks prior to day 0, or 1.5 kg in the 3 to 6 weeks prior to day 0; provided that BMI is not more than 25 kilograms per square meter.
Exclusion criteria
Exclusion criteria: 1) Patients not ready to provide written informed consent. 2) Patient with other severe co-morbidities like renal or hepatic complications, cardiac disease, uncontrolled diabetes or hypercalcemia, severe peripheral neuropathy, active infection, or previous organ allograft. 3) Patients with history of another malignancy. 4) Patients unable to swallow pills or gastrointestinal conditions that might predispose to drug intolerability or poor drug absorption. 5) Pregnant or lactating women. 6) Patients with history of hypersensitivity to any of the regimen to be used in capecitabine, methotrexate and cyclophosphamide. 7) Women who had participated in another clinical trial with any investigational drug within 30 days before study inclusion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome No. 1- Body mass and body composition parameters Outcome No. 2- Performance tests Outcome No. 3- Inflammatory markers Outcome No. 4- Markers of carbohydrate metabolism Outcome No. 5- Markers of lipid metabolism Outcome No. 6- Skeletal muscle wasting parameters Timepoint: Baseline and at the end of the study. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome No. 1- Progression Free Survival (PFS), Overall Survival (OS). Outcome No. 2- Adverse Events (AEs) Outcome No. 3- QoL Assessment Outcome No. 4- Nutritional Screening Outcome No. 5- To study the allelic imbalance from blood/ tissues of TNBC patients. Timepoint: Outcome No. 1, 2, 3, 4- Baseline and at the end of the study. Outcome No. 5- No time point is applicable. | — |
Countries
India
Contacts
Public ContactDr Bhoomika Patel
National Forensic Sciences University, Sector 9, Gandhinagar, Gujarat
Outcome results
None listed