Combination Chemotherapy for Metastatic Breast Cancer

Lilly

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: Gemcitabine; Drug: cisplatin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00191815

B9E-VI-S326

7311

Details and patient eligibility

About

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

Enrollment: 70 patients

Sex: Female

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Gemcitabine + Cisplatin

Experimental group

Treatment:

Drug: cisplatin

Drug: Gemcitabine