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Completed

NCT Number: NCT00919880

Comparison 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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Beijing Cancer Hospital Breast Center

Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

carboplatin+ paclitaxel

Drug

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

paclitaxel

Drug

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

Other names: B

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)

    Time frame: within the first 14 days (plus or minus 3 days) after surgery

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Completed

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Sponsors and collaborators

Lead sponsor

Tao OUYANG

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Jun 12, 2009
Registry last updated
Aug 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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