NCT00068341

Docetaxel and Carboplatin With or Without Trastuzumab Before Surgery in Treating Women With Locally Advanced Breast Cancer

Neoadjuvant Treatment and Molecular Characterization of Locally Advanced Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 74 (actual)
• Sponsor: Jonsson Comprehensive Cancer Center · Academic / Other
• Sex: Female
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies, such as trastuzumab, can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. It is not yet known whether docetaxel and carboplatin are more effective with or without trastuzumab in treating breast cancer. PURPOSE: This randomized phase II trial is studying how well giving docetaxel together with carboplatin and trastuzumab before surgery works compared to docetaxel and carboplatin alone before surgery in treating women with locally advanced breast cancer.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BIOLOGICAL	trastuzumab	Cycle 5-7 post-op only Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV
DRUG	carboplatin	Cycle 1-8 Day 1 or 2 AUC = 6 IV
DRUG	docetaxel	Cycle 1-8 Day 1 or 2: 75 mg/m2 IV
BIOLOGICAL	trastuzumab	Cycle 1-4 pre-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 5-7 post-op Day 1 4mg/kg IV Day 8, 15 2mg/kg IV Cycle 8 Day 1, 8, 15 2mg/kg IV Day 22 6mg/kg IV

Timeline

• Start date: 2003-07-01
• Primary completion: 2013-11-01
• Completion: 2013-11-01
• First posted: 2003-09-11
• Last updated: 2020-09-09
• Results posted: 2017-03-27

Locations

4 sites across 1 country: United States