Combinational Therapy of Capecitabine, Lapatinib and Vinorelbine for the Treatment of Patients With her2/Neu Positive, Relapsed or Metastatic Breast Carcinoma Following Treatment Failure With Trastuzumab (CELAVIE)

NCT01238029 Phase 1 TERMINATED

The purpose of the study is to investigate safety and efficiency of the triple combination of capecitabine, lapatinib and vinorelbine in patients with metastatic breast cancer.

Details

Lead sponsor	Sponsor GmbH
Phase	Phase 1
Status	TERMINATED
Enrolment	12
Start date	2010-10
Completion	2014-07

Conditions

• Metastatic Breast Cancer
• HER2 Positive
• First or Second Line Therapy
• Failure or Contraindication of Trastuzumab Therapy

Interventions

• Lapatinib and Capecitabine and Vinorelbine

Primary outcomes

• Identification of maximal tolerable Dose (MTD) of combination with Capecitabine and Lapatinib and Vinorelbine — 4 months
  Phase I: Identification of Dosis limiting toxicities and maximal tolerable dose for Combinational therapy (Time Frame: within the first 21 days under medication)

Countries

Germany