NCT01891227

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

Capecitabine in Combination With Bendamustine in Women With Pretreated Locally Advanced or Metastatic Her2-negative Breast Cancer, a Phase II Trial

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Arbeitsgemeinschaft medikamentoese Tumortherapie · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

40 eligible patients will be enrolled. A two-stage design efficacy and safety of bendamustine and capecitabine will be evaluated following recruitment of the first 20 patients. Upon favorable results a further 20 patients will be recruited to reach the target population of 40 evaluable patients. Pretreatment for eligible patients must include anthracyclines and/or taxanes.

Conditions

• Breast Cancer

Interventions

Type	Name	Description
DRUG	Capecitabine	Capecitabine will be dosed at 1000mg/m2 twice daily for 14 days, followed by a 7-day rest period for a total cycle time of 21 days (until disease progression or unacceptable toxic effects).
DRUG	Bendamustine	Bendamustine 80mg/m2 will be administered on day 1 and 8 of a three week cycle (for a maximum of eight cycles).

Timeline

• Start date: 2013-08-09
• Primary completion: 2018-03-15
• Completion: 2018-03-15
• First posted: 2013-07-03
• Last updated: 2018-11-07

Locations

8 sites across 1 country: Austria