Completed

Phase II Open Label Study of Gemcitabine, Paclitaxel and Bevacizumab Combination as First Line Treatment for Metastatic Breast Cancer

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Gemcitabine

+ Paclitaxel

+ Bevacizumab

Drug
Who is being recruted

Breast Diseases+3

+ Breast Neoplasms

+ Neoplasms

Over 18 Years
+37 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 2
Interventional
Study Start: February 2006
See protocol details

Summary

Principal SponsorGeorge Albert Fisher
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2006

Actual date on which the first participant was enrolled.

This study will evaluate the time-to-progression (TTP) in patients with metastatic breast cancer, receiving 1st line therapy with bevacizumab in combination with paclitaxel and gemcitabine. Secondary objectives will include response rates and overall survival (OS).

Official TitlePhase II Open Label Study of Gemcitabine, Paclitaxel and Bevacizumab Combination as First Line Treatment for Metastatic Breast Cancer
NCT00403130
Principal SponsorGeorge Albert Fisher
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

31 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Breast DiseasesBreast NeoplasmsNeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Criteria

14 inclusion criteria required to participate
Previously-untreated metastatic breast cancer. May have had prior chest wall irradiation or palliative radiation to bony sites for control of pain or fracture. These sites of disease, however, will not be considered as sites of measurable disease.
Use of bisphosphonates will be permitted.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Granulocyte count ≥ 1500/mm³
Show More Criteria
23 exclusion criteria prevent from participating
Unstable angina
Current, recent (within 4 weeks of the first infusion of this study), or planned participation in an experimental drug study.
Presence of central nervous system or brain metastases
Receiving hormonal therapy
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Gemcitabine + Paclitaxel + Bevacizumab

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Stanford University School of Medicine

Stanford, United StatesOpen Stanford University School of Medicine in Google Maps
CompletedOne Study Center