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Evaluation of Response to Two Schedules of Capecitabine in Patients With Metastatic Breast Cancer

NCT02028494 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2018-09-07

No results posted yet for this study

Summary

The purpose of this study is to compare the efficacy of a novel schedule of an oral anticancer drug, capecitabine, in patients with metastatic breast cancer.

Mathematical models have predicted that 7 days of capecitabine followed by 7 days of rest is an optimal dosing schedule for this drug and previous studies done al Memorial Sloan Kettering Cancer Center support the tolerability of this scheme.

This definitive, randomized trial comparing the efficacy of the new dosage with the conventional dosing schedule in patients with metastatic breast cancer is necessary and we hypothesize it will be superior in terms of efficacy.

Dosing schedules based on mathematical predictions for optimal drug delivery based on efficacy rather than toxicity could facilitate more rapid and economical drug development. This trial is a proof of principle trial of the highest priority.

Conditions

Interventions

DRUG

Capecitabine

Two dosages comparison

Sponsors & Collaborators

  • Breast Cancer Research Foundation

    collaborator OTHER

  • Latin American & Caribbean Society of Medical Oncology

    lead OTHER

Principal Investigators

  • Eduardo Cazap, MD,PhD · Latin American & Caribbean Society of Medical Oncology

  • Tiffany Traina, MD · MSKCC

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-08-31
Primary Completion
2018-12-31
Completion
2019-03-31

Countries

  • Argentina

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02028494 on ClinicalTrials.gov