Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

This study has been completed.
Bristol-Myers Squibb
Roche Pharma AG
Information provided by (Responsible Party):
WiSP Wissenschaftlicher Service Pharma GmbH
ClinicalTrials.gov Identifier:
First received: August 25, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
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.

Condition Intervention Phase
Metastatic Breast Cancer
Drug: paclitaxel plus trastuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Weekly Application of Trastuzumab and Paclitaxel in the Treatment of HER2-overexpressing Metastatic Breast Cancer

Resource links provided by NLM:

Further study details as provided by WiSP Wissenschaftlicher Service Pharma GmbH:

Primary Outcome Measures:
  • Progression-free survival [ Time Frame: Patient follow-up on average for 15 months and up to a maximum of 51 months ] [ Designated as safety issue: No ]

Enrollment: 121
Study Start Date: February 2001
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: paclitaxel/trastuzumab
Single experimental arm in a phase II trial
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)


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01423695

Dr. Matthias John
Glauchau, Sachsen, Germany, D-08371
Sponsors and Collaborators
WiSP Wissenschaftlicher Service Pharma GmbH
Bristol-Myers Squibb
Roche Pharma AG
Principal Investigator: Matthias John, MD Oncology Practice, Glauchau
  More Information

Responsible Party: WiSP Wissenschaftlicher Service Pharma GmbH
ClinicalTrials.gov Identifier: NCT01423695     History of Changes
Other Study ID Numbers: WISP_RO78 
Study First Received: August 25, 2011
Last Updated: August 25, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Albumin-Bound Paclitaxel
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Tubulin Modulators

ClinicalTrials.gov processed this record on May 22, 2016