Paclitaxel in Combination With Carboplatin Versus Paclitaxel Plus Epirubicin in Metastatic Breast Cancer

Tianjin Medical University

Status and phase: Unknown; Phase 4

Conditions: Metastatic Breast Cancer

Treatments: Drug: Paclitaxel, Carboplatin; Drug: Paclitaxel, Epirubicin

Study type: Interventional

Funder types: Other

Identifiers

NCT02207361

CIH-TZS-20140421-02

Details and patient eligibility

About

Paclitaxel plus Epirubicin in metastatic breast cancer is a recommended scheme in National Comprehensive Cancer Network (NCCN) guideline. Paclitaxel in Combination with Carboplatin is also effective in Metastatic Breast Cancer (MBC) in some clinical study with small sample.

Full description

A Randomized Prospective Clinical Trial of Paclitaxel in Combination with Carboplatin Versus Paclitaxel plus Epirubicin as First-Line Treatment in Metastatic Breast Cancer. The primary endpoints of the study is progression free survival (PFS). The secondary endpoints are overall response rate (ORR), overall survival (OS) and safety.

Enrollment: 120 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female ≥ 18 years old, ECOG 0-2 or KPS≥60, Expected lifetime more than 12 weeks.

Exclusion criteria

• Pregnancy, Paclitaxel, platinum and anthracycline-based drugs' allergy, Severe Infection.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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120 participants in 2 patient groups

Paclitaxel, Carboplatin，injection

Experimental group

Description:

Paclitaxel: 175mg/m2, IV, d1 Carboplatin: AUC 5, IV, d1 Every 21 days to 1 course of treatment.

Treatment:

Drug: Paclitaxel, Carboplatin

Paclitaxel, Epirubicin，injection

Active Comparator group

Description:

Paclitaxel: 175mg/m2, IV, d1 Epirubicin: 60-80mg/m2, IV, d1 Every 21 days to 1 course of treatment.

Treatment:

Drug: Paclitaxel, Epirubicin