Effectiveness and Toxicity of Gemcitabine/Lobaplatin Versus Gemcitabine/Cisplatin as Second-line Treatment in Metastatic Breast Cancer

Harbin Medical University

Status and phase: Unknown; Phase 2

Conditions: Breast Cancer

Treatments: Drug: lobaplatin; Drug: cisplatin

Study type: Interventional

Funder types: Other

Identifiers

NCT01483300

BC001

Details and patient eligibility

About

Gemcitabine plus cisplatin has been proved to be an effective regimen as second-line treatment for metastatic breast cancer patients, especially for those previously treated with anthracyclines and taxanes. Lobaplatin, as the third generation of new cancer drug platinum, has a similar anticancer activity to cisplatin, but less kidney toxicity and gastrointestinal reaction. The purpose of the study is to compare the efficacy and safety of gemcitabine/lobaplatin versus gemcitabine/cisplatin in patients with metastatic breast cancer.

Enrollment: 80 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Histologically confirmed metastatic breast cancer
• Disease progression during or after previous 1st line chemotherapy
• Scheduled to receive 2nd line chemotherapy.
• Measurable disease, defined as a least one lesion that can be accurately measured in at least one dimension
• 18 years of age or older
• ECOG performance status of 0-2
• Life expectancy of greater than 6 months

Exclusion criteria

• Previous treatment with one of the study drugs
• Application of other cytotoxic chemotherapy or radiotherapy
• Insufficent renal function (creatinine clearance < 60ml/min)
• Clinically unstable brain metastasis
• Pregancy or lactation
• History of other malignancy within last 5 years.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

lobaplatin

Experimental group

Description:

gemcitabine plus lobaplatin

Treatment:

Drug: lobaplatin

cisplatin

Active Comparator group

Description:

gemcitabine plus cisplatin

Treatment:

Drug: cisplatin