Metastatic Breast Cancer MedDRA version: 8.0 Level: PT Classification code 10055113
Conditions
Interventions
Trade Name: Caelyx
Pharmaceutical Form: Concentrate for solution for infusion
INN or Proposed INN: Doxorubicin hydrochloride (pegylated liposomal)
CAS Number: 25316-40-9
Concentration unit: mg/ml mill
Sponsors
Essex Pharma GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
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 but = 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 =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: · To compare overall response rates (CRs+PRs) between the two treatment groups · To compare overall survival between the two treatment groups · To evaluate the effects of pegylated liposomal doxorubicin and capecitabine on quality of life measured by the EORTC QLQ-C30 and SSQ · To compare time to treatment failure between the two treatment groups · To compare safety/tolerability between the two treatment groups · To evaluate age and comorbidity related treatment burdens in all patients by methods of geriatric assessment ;Main Objective: The primary objective of the study is to compare the time to disease progression (TTP) in patients with metastatic breast cancer treated with either pegylated liposomal doxorubicin (50 mg/m2 q 28 days) or capecitabine (1250 mg/m2 BID x 14 days q 21 days). ;Primary end point(s): The primary endpoint is time to progression (TTP), which is defined in Section 9.2, will be measured in months. Because of the design as a first line study in MBC, overall survival has been chosen as a secondary endpoint only. | — |
Countries
Germany, Spain
Outcome results
None listed