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

NCT ID: NCT00919880

Last Updated: 2014-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

148 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Experimental

Group Type EXPERIMENTAL

carboplatin+ paclitaxel

Intervention Type DRUG

carboplatin AUC 2mg/mL\*min/week, 3 week cycle up to 4 cycles; paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles

paclitaxel

Intervention Type DRUG

paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles

Active Comparator

Group Type ACTIVE_COMPARATOR

paclitaxel

Intervention Type DRUG

paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles

Interventions

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carboplatin+ paclitaxel

carboplatin AUC 2mg/mL\*min/week, 3 week cycle up to 4 cycles; paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles

Intervention Type DRUG

paclitaxel

paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles

Intervention Type DRUG

Other Intervention Names

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A B

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Tao OUYANG

OTHER

Sponsor Role lead

Responsible Party

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Tao OUYANG

Chairman of Breast Center

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Tianfeng Wang, Doctor

Role: STUDY_CHAIR

Beijing Cancer Hospital Breast Center

Locations

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Beijing Cancer Hospital Breast Center

Beijing, Beijing Municipality, China

Site Status

Countries

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China

Other Identifiers

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B04

Identifier Type: -

Identifier Source: org_study_id

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