Efficacy Study of Gemcitabine-Paclitaxel to Treat Metastatic Breast Cancer

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-04-30

Study Completion Date

2008-04-30

Brief Summary

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The purpose of this study is to determine the response rate to a gemcitabine-paclitaxel combination administered on a 3-weekly schedule in Chinese patients with unresectable, locally recurrent breast cancer or metastatic breast cancer.

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Detailed Description

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Conditions

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Metastatic Breast Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Group Type EXPERIMENTAL

gemcitabine

Intervention Type DRUG

1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression

paclitaxel

Intervention Type DRUG

175 mg/m2, intravenous (IV), every 21 days until disease progression

Interventions

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gemcitabine

1250 mg/m2, intravenous (IV), day 1 and day 8 every 21 days until disease progression

Intervention Type DRUG

paclitaxel

175 mg/m2, intravenous (IV), every 21 days until disease progression

Intervention Type DRUG

Other Intervention Names

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LY188011 Gemzar

Eligibility Criteria

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Inclusion Criteria

* Female patients of Chinese origin with histologically or cytologically proven diagnosis of breast cancer.
* Unresectable, locally recurrent breast cancer or stage IV disease.
* Have at least one measurable lesion as defined by Response Evaluation Criteria In Solid Tumors (RECIST) criteria.
* Performance Status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) Scale
* Treatment with an anthracycline-based chemotherapy regimen in the adjuvant/neoadjuvant setting with subsequent disease relapse.

Exclusion Criteria

* Prior chemotherapy for unresectable, locally advanced breast cancer or metastatic disease.
* Concurrent administration of any other tumor therapy, including cytotoxic chemotherapy, hormonal therapy, and immunotherapy.
* Known or suspected brain metastasis or second primary malignancy that is clinically detectable at the time of consideration for study enrollment.
* Active infection or other serious condition.
* Pregnant or breastfeeding.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No