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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919880
• Other study ID #: B04
• Status: Completed
• Phase: Phase 2
• First received: June 4, 2009
• Last updated: August 12, 2014
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: August 2014
• Source: Peking University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 148
• Est. completion date: December 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

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

Locations

Country	Name	City	State
China	Beijing Cancer Hospital Breast Center	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Tao OUYANG

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No