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An Open -Label Study to Evaluate the Effect of Combination Therapy With Epothilone D and Herceptin on Tumor Response in Patients With HER-2 Overexpressing Locally Advanced or Metastatic Breast Cancer.


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

An Open -Label Study to Evaluate the Effect of Combination Therapy With Epothilone D and Herceptin on Tumor Response in Patients With HER-2 Overexpressing Locally Advanced or Metastatic Breast Cancer.


Inclusion Criteria:



- women >=18 years;

- locally advanced or metastatic breast cancer;

- HER-2 overexpression (FISH + or IHC 3+);

- >=1 measurable lesion;

- up to one prior anthracycline-based chemotherapy regimen in a metastatic setting.

Exclusion Criteria:

- pre-existing neuropathy >=grade 2;

- known CNS metastases;

- congestive heart failure, or myocardial infarction within the last 6 months;

- previous malignancies in last 5 years, except for cured basal cell cancer of the
skin, or cancer in situ of the cervix.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Response rate (RECIST criteria)

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

United States: Food and Drug Administration

Study ID:

NO17328

NCT ID:

NCT00337649

Start Date:

May 2004

Completion Date:

April 2008

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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