Trial | NCT01423695  Report issue

Title

Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer
Weekly Application of Trastuzumab and Paclitaxel in the Treatment of HER2-overexpressing Metastatic Breast Cancer

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    121
The 3 weekly combination of trastuzumab and paclitaxel has been approved for the treatment of advanced breast cancer based on a large pivotal study. However, mono and combination chemotherapy trials suggest that weekly paclitaxel has a better therapeutic index, especially in the palliative setting. The present trial examines the efficacy and safety of weekly paclitaxel over a limited duration combined with continued trastuzumab in HER2+ patients.
Study Started
Feb 28
2001
Primary Completion
Dec 31
2009
Study Completion
Dec 31
2009
Last Update
Aug 26
2011
Estimate

Drug paclitaxel plus trastuzumab

Weekly paclitaxel (90 mg/m² iv, 12 courses) plus weekly trastuzumab (4mg/kg body weight iv as loading dose, 2 mg/kg iv from week 2 onwards; continued until disease progression)

paclitaxel/trastuzumab Experimental

Single experimental arm in a phase II trial

Criteria 

Inclusion Criteria:

histologically confirmed metastatic breast cancer overexpressing HER2
pretreatment with anthracycline in either the adjuvant or palliative setting.
HER2 positivity was defined as 2+ or 3+ overexpression using the DAKO HercepTest, confirmed by fluorescence in-situ hybridization (FISH) if 2+.
informed consent

Exclusion Criteria:

more than 1 chemotherapy for advanced disease
taxane or trastuzumab pretreatment
brain metastases
Eastern Cooperative Oncology Group (ECOG) performance status >1
pregnancy or lactation, childbearing potential without reliable contraception
clinically significant cardiac disease,
neutrophils <1500/µl, platelets <75,000/µl
total bilirubin and creatinine >1.5 × the upper limit of normal
No Results Posted