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Study of Neoadjuvant Docetaxel and Cyclophosphamide in Locally Advanced or Node Positive Primary Breast Cancer With Companion Pharmacokinetic and Pharmacogenomic Analyses

NCT01540110 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 21

Last updated 2018-09-14

No results posted yet for this study

Summary

Primary

The purpose of this study is to evaluate tumour pathological complete response rate after six cycles of neoadjuvant docetaxel and cyclophosphamide in an Asian population.

Secondary

To assess:

1. Pharmacokinetics (PK) and pharmacogenomics (PG) of docetaxel cyclophosphamide in Asian patients,
2. Safety and toxicity of docetaxel cyclophosphamide in Asian patients, and
3. To determine efficacy of short course (3 days) filgrastim in primary and secondary prophylaxis against febrile neutropenia in patients receiving docetaxel and cyclophosphamide.

Conditions

Interventions

DRUG

Neoadjuvant Docetaxel and Cyclophosphamide

5.1.1 Docetaxel Docetaxel at a dose of 75 mg/m2 will be administered by intravenous infusion over 90 minutes (AFTER completion of cyclosphosphamide 600 mg/m2) on D1 every 21 days for 6 cycles using nonpolyvinylchloride tubing. Standard premedication with oral dexamethasone 8 mg bd on D-1, D1 and D2 will be administered. Alternatively, intravenous dexamethasone 8 mg before docetaxel followed by oral dexamethasone 8 mg bd on D1 and D2 can be given. Routine prevention of chemotherapy induced emesis will be administered (see 5.2.2) 5.1.2 Cyclophosphamide Cyclophosphamide 600 mg/m2 by slow intravenous infusion over 10 minutes (BEFORE docetaxel) will be administered every 21 days for 6 cycles. No premedications are required except for routine prevention of chemotherapy induced emesis (see 5.2.2)

Sponsors & Collaborators

  • National Cancer Centre, Singapore

    lead OTHER

Principal Investigators

  • Rebecca Dent, MD · National Cancer Centre, Singapore

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-11
Primary Completion
2015-10-20
Completion
2015-10-20

Countries

  • Singapore

Study Locations

More Related Trials

Entities

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 NCT01540110 on ClinicalTrials.gov