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

August 12, 2014 updated by: Tao OUYANG

A Phase II Randomized Clinical Trial of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

148

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing
      • Beijing, Beijing, China
        • Beijing Cancer Hospital Breast Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Experimental
Drug: 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
Other Names:
  • A
Drug: paclitaxel
paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles
Other Names:
  • B
Active Comparator: Active Comparator
Drug: paclitaxel
paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles
Other Names:
  • B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
significant effect rate (the proportion of G4 and G5, graded by Miller & Payne Method); null effect rate (the proportion of G1 and G2)
Time Frame: within the first 14 days (plus or minus 3 days) after surgery
within the first 14 days (plus or minus 3 days) after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tao OUYANG

Investigators

  • Study Chair: Tianfeng Wang, Doctor, Beijing Cancer Hospital Breast Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

June 4, 2009

First Submitted That Met QC Criteria

June 11, 2009

First Posted (Estimate)

June 12, 2009

Study Record Updates

Last Update Posted (Estimate)

August 15, 2014

Last Update Submitted That Met QC Criteria

August 12, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B04

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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