Combination Chemotherapy for 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

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-10-31

Study Completion Date

2007-10-31

Brief Summary

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The purpose of this study is to determine the objective tumor response of the first-line therapy combination of gemcitabine and cisplatin in patients with metastatic breast cancer

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Detailed Description

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Conditions

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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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Gemcitabine + Cisplatin

Group Type EXPERIMENTAL

Gemcitabine

Intervention Type DRUG

Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).

cisplatin

Intervention Type DRUG

Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).

Interventions

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Gemcitabine

Gemcitabine (30 min intravenous infusion) dose of 1000mg/m2 on Day 1 and Day 8 (21 day cycle).

Intervention Type DRUG

cisplatin

Cisplatin (30-120 min intravenous infusion) dose of 35 mg/m2 on Day 1 and Day 8 (21 day cycle).

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* You are female in the age of 18 to 75 years old.
* You have been diagnosed with the metastatic breast cancer.
* You have desire and an opportunity to visit your doctor in medical site, both during realization of the active treatment program, and within 24 months of medical follow up.
* You must sign this informed consent form

Exclusion Criteria

* You are pregnant or breastfeeding.
* Your laboratory parameters fall outside the limits, admitted by requirements of the present clinical study.
* You have been diagnosed with serious concomitant or acute infectious disease.
* You have used experimental medications within the last month.

Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No