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An Open-label Study of the Effect of First-line Herceptin Alone or in Combination With a Taxane on Tumor Response and Disease Progression in Patients With Metastatic Breast Cancer Who Relapsed After Receiving Adjuvant Herceptin for HER2-positive Early Breast Cancer


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

Thank you

Trial Information

An Open-label Study of the Effect of First-line Herceptin Alone or in Combination With a Taxane on Tumor Response and Disease Progression in Patients With Metastatic Breast Cancer Who Relapsed After Receiving Adjuvant Herceptin for HER2-positive Early Breast Cancer


Inclusion Criteria:



- at least 10 months of Herceptin treatment for HER2-positive early breast cancer;

- metastatic breast cancer >=12 months after discontinuation of Herceptin;

- measurable disease.

Exclusion Criteria:

- previous chemotherapy for metastatic breast cancer;

- brain metastases;

- invasive malignancy other than metastatic breast cancer.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Tumor response rate and progression

Outcome Time Frame:

Event driven

Safety Issue:

No

Principal Investigator

Clinical Trials

Investigator Role:

Study Director

Investigator Affiliation:

Hoffmann-La Roche

Authority:

Australia: Ministry of Health

Study ID:

WO17299

NCT ID:

NCT00475670

Start Date:

February 2005

Completion Date:

September 2012

Related Keywords:

  • Breast Cancer
  • Breast Neoplasms

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