A multinational, Subsidiary Sponsored, Randomized, Open-Label StudyComparing Treatment with Either Pegylated Liposomal Doxorubicin or Capecitabine as First Line Chemotherapy for Metastatic Breast Cancer - PELICA

• Conditions: Metastatic Breast Cancer; MedDRA version: 8.0Level: PTClassification code 10055113

• Registration Number: EUCTR2005-003164-35-DE
• Lead Sponsor: Essex Pharma GmbH

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-09-09
• Last Update Posted: 17 December 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 210

Inclusion Criteria

· Patients must be female,
· Patients must have metastatic disease of a cytological or histological confirmed breast cancer,
· Patients must be 18 years or older,
· Patients should have evaluable disease (at least uni-dimensionally measurable lesion according to the RECIST criteria in at least one site that has not been irradiated), however, patients who only have non-measurable / evaluable disease are not excluded. Also patients with only bone metastasis are not excluded,
· Patients must have an ECOG 0 - 2,
· Patients must have a sufficient life expectancy to be treated with chemotherapy,
· Patients must be willing and able to complete study questionnaires,
· Patients must have adequate renal function as evidenced by serum creatinine <= 1.5 mg/dL, however if serum creatinine is > 1.5 mg/dL but <= 1.8 mg/dL, then patients must have a creatinine clearance of >= 45 mL/min,
· Patients must have adequate bone marrow function as evidenced by leucocyte count greater 3,5 g/L, hemoglobin >= 9.0 g/dL, and platelet count >= 100 x 10^9/L,
· Patients must have adequate liver function as evidenced by bilirubin of <= 1.5 times the upper limits of normal (ULN) and alkaline phosphatase <= 3 times, ULN unless related to liver metastasis,
· Patients must have Na and K values within normal limits,
· Patients must have signed an informed consent document indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study,
· Patients whose clinical condition (co-morbidity) allows a treatment with monotherapy or who expressed their wish to be treated with monotherapy
· Patients where a therapy with Trastuzumab is not indicated

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

· History of receiving prior therapy in the metastatic setting [Note: patients may have had hormonal therapy or chemotherapy in the adjuvant setting; patients may have received hormonal therapy in metastatic setting, patients may have received local radiotherapy for symptom relief].
· Patients who are taking concomitant medications (except bisphosphonates) for metastatic disease, including hormonal therapy, radiation therapy (except local irradiation for symptom relief only). Trastuzumab, or biologicals are also not permitted.
· Patients with Her-2/neu over expressing tumors are excluded with the most recent evaluation as the relevant result (immunologically Her2neu 3+ positive or
Her2neu-2+ positive and 'Fish' positive
· History of treatment with capecitabine
· History of treatment with anthracyclines in the adjuvant setting exceeding cumulative doses of anthracyclines by more than 360 mg/m^2 doxorubicin (or equivalents, i.e. 600mg/m^2 epirubicine).
· Patients with anthracycline resistant disease are not permitted. Anthracycline resistance is defined as development of locally recurrent or metastatic disease while on adjuvant anthracycline therapy, or relapse less than 12 months after completion of anthracycline therapy.
· Evidence of primary or metastatic malignancy involving the central nervous system unless previously treated and asymptomatic for 3 months or greater.
· Patients with reduced liver functions (evidenced by bilirubin of above 1.5 times the upper limits of normal (ULN), except for patients with liver metastasis where bilirubin should not exceed 5 times ULN); alkaline phosphatase above 3 times ULN (except related to liver metastasis, in which case <= 5 x ULN).
· Dyspnea on exertion (if not caused by lung metastases or pleural effusions).
· History of cardiac disease, with New York Heart Association Class II or greater, or clinical evidence of congestive heart failure or myocardial infarct within less than six months or an LVEF below 50%.
· Woman with childbearing potential with insufficient contraception [e.g. intra-uterine device (IUD) are regarded as sufficient] during the study period and the six months following the last study drug application.
· Existing pregnancy or lactation (note on pregnancy test).
· Existing doubts on ability and willingness of the subject for cooperation.
· Participation of the subject at a clinical study within the last 30 days.
· Participation of the subject in the same clinical study at an earlier date.
· Concomitant participation in another study than the one described here.
· Abuse of drugs, alcohol, pharmaceuticals.
· Patients with positive estrogen- / progesterone-receptor status, where an endocrine therapy is indicated. However, patients progressing under hormonal therapy are not excluded
· Patients with known hypersensitivity to doxorubicinhydrochlorid or to any of the excipients OR known hypersensitivity to capecitabine or fluorouracil or to any of the excipients
· Patients with known DPD (dihydro pyrimidine) deficiency
· Patients who are receiving a concomitant treatment with sorivudine or its chemically related analogues, such as brivudine
· Strong remission pressure that requires polychemotherapy with the exception of patients who are not suitable for a treatment with polychemotherapy or not accepting polychemotherapy

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified