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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01423695
Other study ID # WISP_RO78
Secondary ID
Status Completed
Phase Phase 2
First received August 25, 2011
Last updated August 25, 2011
Start date February 2001
Est. completion date December 2009

Study information

Verified date August 2011
Source WiSP Wissenschaftlicher Service Pharma GmbH
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 121
Est. completion date December 2009
Est. primary completion date December 2009
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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)

Locations

Country Name City State
Germany Dr. Matthias John Glauchau Sachsen

Sponsors (3)

Lead Sponsor Collaborator
WiSP Wissenschaftlicher Service Pharma GmbH Bristol-Myers Squibb, Roche Pharma AG

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Progression-free survival Patient follow-up on average for 15 months and up to a maximum of 51 months No
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