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Phase IV.II, Clinical Trial, With the Combination of Pegylated Liposomal Doxorubicin (Caelyx), Cyclophosphamide and Trastuzumab (Herceptin) in Patients With Metastatic Breast Cancer With Overexpression of HER2/Neu


Phase 2
18 Years
70 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Phase IV.II, Clinical Trial, With the Combination of Pegylated Liposomal Doxorubicin (Caelyx), Cyclophosphamide and Trastuzumab (Herceptin) in Patients With Metastatic Breast Cancer With Overexpression of HER2/Neu


Inclusion Criteria:



- Patients must sign an informed consent before of especific procedures of clinical
trial.

- Patients with histologically confirmed breast cancer and overexpression of Her2neu.

- Age> 18 years.

- ECOG equal or < 2.

- Patients have not been treated previously with chemotherapy for metastatic disease.

- Patients must have at least one measurable lesion according to RECIST criteria.

- Patients should have an adequate organ function to tolerate chemotherapy.

Exclusion Criteria:

- Patients with hypersensitivity reactions to any of the medications of the clinical
trial.

- Patients who are pregnant or lactating are not eligible.

- Hepatic disease.

- Not controlled active infection

- Symptomatic metastatic brain cancer

- Previous adyuvant treatment with antrhacyclines with a total accumulated dose > 300
mg/m2 (Doxorubicin) or > 600 mg/m2 (Epirubicin)

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:

To evaluate objective response rate

Principal Investigator

Miguel Martín, MD., PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Spanish Breast Cancer Reserach Group

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GEICAM/2004-05

NCT ID:

NCT00258960

Start Date:

February 2006

Completion Date:

July 2008

Related Keywords:

  • Breast Cancer
  • HER2 positive breast cancer
  • Metastatic breast cancer
  • Breast Neoplasms

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