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NCT01540110

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

Completed Phase 2 Last updated 14 September 2018
What this trial tests

Phase 2 trial testing Neoadjuvant Docetaxel and Cyclophosphamide in Breast Cancer in 21 participants. Completed in 20 October 2015.

Timeline
11 August 2010
Primary endpoint
20 October 2015
20 October 2015

Quick facts

Lead sponsorNational Cancer Centre, Singapore
PhasePhase 2
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment21
Start date11 August 2010
Primary completion20 October 2015
Estimated completion20 October 2015
Sites1 location across Singapore

Drugs / interventions tested

Conditions studied

Sponsor

National Cancer Centre, Singapore

Who can join

21 and older, any sex, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other recruiting trials for Breast Cancer

Currently open trials in the same condition.

Other National Cancer Centre, Singapore trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01540110.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing