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


Phase 2
18 Years
N/A
Not Enrolling
Both
Metastatic Breast Cancer

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Trial Information

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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Progression-free survival

Outcome Time Frame:

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

Safety Issue:

No

Principal Investigator

Matthias John, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oncology Practice, Glauchau

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

WISP_RO78

NCT ID:

NCT01423695

Start Date:

February 2001

Completion Date:

December 2009

Related Keywords:

  • Metastatic Breast Cancer
  • Breast Neoplasms

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