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Weekly Paclitaxel and Trastuzumab in Metastatic Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01423695
Recruitment Status : Completed
First Posted : August 26, 2011
Last Update Posted : August 26, 2011
Bristol-Myers Squibb
Roche Pharma AG
Information provided by (Responsible Party):
WiSP Wissenschaftlicher Service Pharma GmbH

Brief 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.

Condition or disease Intervention/treatment Phase
Metastatic Breast Cancer Drug: paclitaxel plus trastuzumab Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 121 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Weekly Application of Trastuzumab and Paclitaxel in the Treatment of HER2-overexpressing Metastatic Breast Cancer
Study Start Date : February 2001
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
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)

Primary Outcome Measures :
  1. Progression-free survival [ Time Frame: Patient follow-up on average for 15 months and up to a maximum of 51 months ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01423695

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

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Responsible Party: WiSP Wissenschaftlicher Service Pharma GmbH Identifier: NCT01423695     History of Changes
Other Study ID Numbers: WISP_RO78
First Posted: August 26, 2011    Key Record Dates
Last Update Posted: August 26, 2011
Last Verified: August 2011

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