Comparison of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer
A Phase II Randomized Clinical Trial of Neo-adjuvant Weekly Paclitaxel With or Without Carboplatin in Early Breast Cancer
1 other identifier
interventional
148
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2 breast-cancer
Started Jul 2009
Shorter than P25 for phase_2 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2009
CompletedFirst Posted
Study publicly available on registry
June 12, 2009
CompletedStudy Start
First participant enrolled
July 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2010
CompletedAugust 15, 2014
August 1, 2014
1 year
June 4, 2009
August 12, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
significant effect rate (the proportion of G4 and G5, graded by Miller & Payne Method); null effect rate (the proportion of G1 and G2)
within the first 14 days (plus or minus 3 days) after surgery
Study Arms (2)
Experimental
EXPERIMENTALActive Comparator
ACTIVE COMPARATORInterventions
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 80mg/m2/week, 3 week cycle up to 4 cycles
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tao OUYANGlead
Study Sites (1)
Beijing Cancer Hospital Breast Center
Beijing, Beijing Municipality, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Tianfeng Wang, Doctor
Beijing Cancer Hospital Breast Center
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Chairman of Breast Center
Study Record Dates
First Submitted
June 4, 2009
First Posted
June 12, 2009
Study Start
July 1, 2009
Primary Completion
July 1, 2010
Study Completion
December 1, 2010
Last Updated
August 15, 2014
Record last verified: 2014-08