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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Tao OUYANG, Peking University
ClinicalTrials.gov Identifier:
NCT00919880
First received: June 4, 2009
Last updated: August 12, 2014
Last verified: August 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: carboplatin+ paclitaxel
Drug: paclitaxel
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II Randomized Clinical Trial of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer

Resource links provided by NLM:


Further study details as provided by Peking University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 148
Study Start Date: July 2009
Study Completion Date: December 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: A
Drug: paclitaxel
paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles
Other Name: B
Active Comparator: Active Comparator Drug: paclitaxel
paclitaxel 80mg/m2/week, 3 week cycle up to 4 cycles
Other Name: B

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00919880

Locations
China, Beijing
Beijing Cancer Hospital Breast Center
Beijing, Beijing, China
Sponsors and Collaborators
Tao OUYANG
Investigators
Study Chair: Tianfeng Wang, Doctor Beijing Cancer Hospital Breast Center
  More Information

No publications provided

Responsible Party: Tao OUYANG, Chairman of Breast Center, Peking University
ClinicalTrials.gov Identifier: NCT00919880     History of Changes
Other Study ID Numbers: B04
Study First Received: June 4, 2009
Last Updated: August 12, 2014
Health Authority: China: Food and Drug Administration

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Carboplatin
Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Therapeutic Uses
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014