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Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

This study has been completed.
Sponsor:
Collaborators:
Bristol-Myers Squibb GmbH
Roche Pharma AG
Information provided by (Responsible Party):
WiSP Wissenschaftlicher Service Pharma GmbH
ClinicalTrials.gov Identifier:
NCT01423695
First received: August 25, 2011
Last updated: NA
Last verified: August 2011
History: No changes posted
  Purpose

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:

U.S. FDA Resources

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)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01423695

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

No publications provided

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
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Paclitaxel
Trastuzumab
Tubulin Modulators
 Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 19, 2013