Comparison of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer

Tao OUYANG

Status and phase: Completed; Phase 2

Conditions: Breast Cancer

Treatments: Drug: paclitaxel; Drug: carboplatin+ paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT00919880

B04

Details and patient eligibility

About

The purpose of this study is to determine whether neo-adjuvant weekly paclitaxel with carboplatin is better than paclitaxel alone in efficiency and safety in early breast cancer, and to explore whether ultrasound and magnetic resonance imaging can predict the efficiency of neo-adjuvant chemotherapy.

Enrollment: 148 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• female patients between 18 and 65 years old
• pathological diagnosed invasive breast cancer; medium and high risk primary breast cancer according to St. Gallen 2007
• able and willing to give consent to participate in the study

Exclusion criteria

• pregnant or lactating females
• previous treatment for breast cancer
• other tumor history
• instable complication (e.g., myocardial infarction within 6 months, arrhythmia, unstable diabetes, hypercalcemia) or uncontrolled infection
• allergy history to similar drugs
• concurrent disease or condition that would make the patient inappropriate for study participation
• resist to participate in the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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148 participants in 2 patient groups

Experimental

Experimental group

Treatment:

Drug: carboplatin+ paclitaxel

Drug: paclitaxel

Active Comparator

Active Comparator group

Treatment:

Drug: paclitaxel