Pegylated Liposomal Doxorubicin (Caelyx(R)) as Monotherapy in Elderly Patients With Locally Advanced and/or Metastatic Breast Cancer (Study P05059)
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Caelyx (pegylated liposomal doxorubicin; SCH 200746)
Intervention description: Caelyx will be administered intravenously at a dose of 40 mg/m^2 on day one every 4 weeks until progression, or unacceptable toxicity, or other reason to discontinue the study treatment. The drug is diluted in 250 ml glucose 5% (500 ml for doses >=90 mg).
Intervention MeSH terms: Doxorubicin; Liposomal doxorubicin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 25.0
Sex: Female
Minimum age: 65 Years
Healthy volunteers: No

Summary:

      The purpose of this study is to evaluate the safety and efficacy of pegylated liposomal
      doxorubicin (Caelyx) in elderly patients who are to receive first-line chemotherapy for
      metastatic or locally advanced breast cancer, not amenable to surgery.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Patients meeting the following criteria will be eligible for enrollment.

               -  Female patients with histologic or cytologic diagnosis of breast cancer that is
                  locally advanced or metastatic, and not amenable to surgery.

               -  Age >= 65 years.

               -  World Health Organization (WHO) Performance Status 0 - 2

               -  Measurable disease in accordance with Response Evaluation Criteria in Solid
                  Tumors (RECIST) criteria. Patients with bone metastasis can also be included but
                  will be evaluated according to WHO criteria. Patients with non-measurable disease
                  can also be included.

               -  Left ventricular ejection fraction (LVEF) >= 50% verified by ultrasound
                  cardiography (UCG); no clinical signs of heart disease.

               -  Normal organ function, except due to disease involvement, however maximum
                  deviation:

                    -  S-creatinine <= 1.5 x upper normal limit;

                    -  Bilirubin <= 2 x upper normal limit;

                    -  Alanine aminotransferase (ALAT) and/or aspartate aminotransferase (ASAT) <=
                       3 x upper normal limit. In case of liver metastases, ALAT and/or ASAT <= 5 x
                       upper normal limit.

               -  Adequate bone marrow function, ie:

                    -  Platelets >= 100 x 10^9/L;

                    -  Neutrophils >= 1.5 x 10^9/L;

                    -  White Blood Cell (WBC) >= 3.0 x 10^9/L;

                    -  Hemoglobin > 90 g/L.

               -  Life expectancy >= 12 weeks.

               -  Patients having received oral and written information and having provided written
                  informed consent.

        Exclusion Criteria:

          -  Patients will not be enrolled if any of the following conditions apply.

               -  Previous chemotherapy for metastatic disease. (The patient may have received
                  previous endocrine therapy or single-drug Herceptin. Intrapleural or
                  intrapericardial Novantrone is allowed.)

               -  Recurrence <= 12 months after adjuvant anthracycline-containing treatment and/or
                  prior doxorubicin > 300 mg/m^2 or epirubicin > 540 mg/m^2.

               -  Myocardial infarction within 6 months of planned inclusion.

               -  Symptomatic brain metastases.

               -  Human Epidermal growth factor Receptor 2 (HER-2) positivity eligible for
                  treatment with trastuzumab, or estrogen receptor (ER) positivity eligible for
                  hormonal therapy.

               -  Allergy to anthracyclines.

               -  Uncontrolled infection.

               -  Other not radically treated malignancy.

               -  Other disease or condition contraindicating treatment or not allowing follow-up.