drugset / Trial / NCT01891227

Capecitabine + Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer

NCT01891227 ↗

Phase 2 Completed 40 enrolled Study Group of Medical Tumour Therapy (AGMT)
NaSingle-groupOpen-labelTreatment

Summary

Patients with pretreated, Her2-negative, advanced breast cancer will receive chemotherapy with capecitabine and bendamustine for a maximum of eight cycles and afterwards capecitabine alone until disease progression or unacceptable toxic effects. Safety assessments will be conducted in 3-weekly intervals, efficacy assessments (CT or MRI) will be conducted every 9 weeks. Aim of this study is to determine whether treatment with capecitabine in combination with bendamustine is efficacious and safe.

Timeline

Start
2013-08-09
Primary completion
2018-03-15
Completion
2018-03-15

Drugs

EvaluationDrugModalityDoseRoute
Subject Bendamustine Small molecule 80 mg/m2 Intravenous
Subject Capecitabine Small molecule 1000 mg/m2 Oral

Indications