NCT00450762

Gemcitabine + Carboplatin in Breast Cancer

Gemcitabine Plus Carboplatin in Patients With Pretreated Metastatic Breast Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: —
• Sponsor: Ludwig-Maximilians - University of Munich · Academic / Other
• Sex: Female
• Age: 18 Years – 75 Years
• Healthy volunteers: —

Summary

The rational for this trial is given by the knowledge that gemcitabine acts as a potent inhibitor of DNA repair and therefore may prevent adequate repair of platin-induced DNA damage. Gemcitabine is an excellent choice for combination therapy by its unique mechanism of action and favourable toxicity profile. The combination of gemcitabine and cisplatin was shown to be effective in several trials, producing response rates of 30-52 % in patients with pretreated metastatic breast cancer. To improve on tolerability and handling of the regime carboplatin may be the more appropriate choice for treatment. The mechanism of action of carboplatin is very similar to that of cisplatin. The rational for combining gemcitabine and carboplatin is based on their single-agent activities in metastatic breast cancer, the activity of this combination in other malignancies and on the fact that carboplatin has demonstrated efficacy comparable with cisplatin in several tumor types.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	gemcitabine
DRUG	carboplatin

Timeline

• Start date: 2004-03-01
• Completion: 2006-10-01
• First posted: 2007-03-22
• Last updated: 2007-03-22