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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00919880
Recruitment Status : Completed
First Posted : June 12, 2009
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment Phase
Breast Cancer Drug: carboplatin+ paclitaxel Drug: paclitaxel Phase 2

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 148 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : July 2009
Primary Completion Date : July 2010
Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arms and Interventions

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 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


Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Tao OUYANG, Chairman of Breast Center, Peking University
ClinicalTrials.gov Identifier: NCT00919880     History of Changes
Other Study ID Numbers: B04
First Posted: June 12, 2009    Key Record Dates
Last Update Posted: August 15, 2014
Last Verified: August 2014

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Albumin-Bound Paclitaxel
Carboplatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action