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
- Patients must sign an informed consent before of especific procedures of clinical
- 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.
- Patients with hypersensitivity reactions to any of the medications of the clinical
- 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:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
To evaluate objective response rate
Miguel Martín, MD., PhD
Spanish Breast Cancer Reserach Group
Spain: Spanish Agency of Medicines
- Breast Cancer
- HER2 positive breast cancer
- Metastatic breast cancer
- Breast Neoplasms