Multi-parametric profiling of cancer patient samples and metronomic chemotherapy for forensic and treatment outcomes.

Not Applicable

• Conditions: Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

• Registration Number: CTRI/2024/07/070026
• Lead Sponsor: A

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

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

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified