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OpenTrials
Completed

NCT Number: NCT01423695

Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

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.

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Key information

Conditions

Metastatic Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Dr. Matthias John

Glauchau, Saxony, D-08371, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

paclitaxel plus trastuzumab

Drug

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)

Primary outcomes

  1. Progression-free survival

    Time frame: Patient follow-up on average for 15 months and up to a maximum of 51 months

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Sponsors and collaborators

Lead sponsor

WiSP Wissenschaftlicher Service Pharma GmbH

Other

Collaborators

  • Bristol-Myers Squibb
  • Roche Pharma AG

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2009
Study completion
2009
First posted
Aug 26, 2011
Registry last updated
Aug 26, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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