NCT00691379

Weekly Paclitaxel/Carboplatin/Bevacizumab as First Line Therapy for Triple Negative Breast Cancer

Weekly Paclitaxel-carboplatin Plus Bevacizumab as First Line Therapy for Patients With Triple Negative (ER-,PR-,HER2-) Metastatic Breast Cancer. A Multicenter Phase I-II Study

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Hellenic Oncology Research Group · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study will evaluate the efficacy of weekly paclitaxel-carboplatin combination plus bevacizumab as first line treatment in patients with metastatic triple negative breast cancer. Furthermore, the efficacy of the combination therapy will be correlated with the presence of circulating tumor cells (CTCs) in this population

Detailed description

Breast cancer with absent or low expression of hormone receptors and HER2 (triple negative) does not respond to hormonal or biological therapy with trastuzumab. However, triple negative breast cancers are highly sensitive to chemotherapy. The combination of paclitaxel and carboplatin administered on a weekly basis is active and well tolerated. Recently, initial therapy of metastatic breast cancer with paclitaxel plus bevacizumab demonstrated prolonged progression-free survival, as compared with paclitaxel alone

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Carboplatin	Carboplatin (IV) 2 AUC on day 1,8,15. Treatment repeats every 4 weeks until progression
DRUG	Bevacizumab	Bevacizumab (IV) 10 mg/kg on day 1,15. Treatment repeats every 4 weeks until progression
DRUG	Paclitaxel	Paclitaxel (IV) 90 mg/m2,on day 1,8,15. Treatment repeats every 4 weeks until progression

Timeline

• Start date: 2008-04-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2008-06-05
• Last updated: 2016-09-22

Locations

11 sites across 1 country: Greece