Phase III Study of Gemcitabine Plus a Cytotoxic Agent Versus Two Cytotoxic Agents

Phase III Study of Docetaxel in Combination With Gemcitabine Versus Docetaxel in Combination With Capecitabine in Patients With Locally Advanced or Metastatic Breast Cancer

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00191438

Enrollment

300

Registered

2005-09-19

Start date

2002-10-31

Completion date

2007-03-31

Last updated

2007-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Neoplasms

Brief summary

This is a phase III randomized study which compares two different regimens of chemotherapy. The purpose of the study is to determine which of the two regimens will make the tumor smaller or disappear, and for how long. In addition the disease-related symptoms will be evaluated. The safety of the drugs will be determined based upon evaluation of the side effects

Interventions

DRUGgemcitabine

DRUGcapecitabine

DRUGdocetaxel

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Locally advanced and/or metastatic breast cancer. * Measurable disease * Previously treated with anthracycline

Exclusion criteria

* Patients with inflammatory breast disease

Design outcomes

Primary

Measure	Time frame
Progression free survival. The final analysis will occur when 250 patients have progressed or died.	—

Secondary

Measure	Time frame
Overall toxicity	—
Quality of Life	—
Overall Survival	—
Overall Response Rate	—
Time to Treatment Failure	—

Countries

France, Germany, Italy, Netherlands, Spain, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026