NCT00093145

Study of Albumin-bound Paclitaxel (Abraxane) in Combination With Carboplatin and Herceptin in Patients With Advanced Breast Cancer

A Phase II Study of Weekly Dose-Dense Nanoparticle Paclitaxel (ABI-007), Carboplatin With Herceptin® As First-Line Therapy of Advanced HER-2 Positive Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 32 (actual)
• Sponsor: Celgene · Industry
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This trial will treat patients with advanced breast cancer with a new anti-cancer medicine used in combination with two existing anti-cancer medications: Albumin-bound paclitaxel (ABI-007), Carboplatin and Herceptin. Participants will be given the combination therapy on a weekly basis and may continue on therapy as long as their condition improves and drug toxicity is tolerated.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Albumin-bound paclitaxel	Administered by intravenous infusion.
DRUG	Carboplatin	Carboplatin dose was calculated using a modified Calvert formula (creatinine clearance was substituted for GFR): Total dose (mg) = (target AUC) x (creatinine clearance + 25). Note: AUC = 6 was initially targeted, but could be decreased due to toxicity.
DRUG	Herceptin®	Administered by IV infusion

Timeline

• Start date: 2004-06-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2004-10-05
• Last updated: 2019-11-25
• Results posted: 2013-07-17

Locations

14 sites across 1 country: United States