NL-OMON25134尚未招募不适用

A randomized, open-label phase III study of first line chemotherapy in older metastatic breast cancer patients, comparing intravenous pegylated liposomal doxorubicin with oral capecitabine; and the incorporation of a complete geriatric assessment.

Borstkanker Onderzoeks Groep (BOOG)Plesmanlaan 1251066 CX Amsterdam00-31-(0)20-346 2547boog@ikca.nl0 个研究点目标入组 154 人开始时间: 待定最近更新: 2024年2月28日

适应症

试验速览

•1. Female patients with metastatic breast cancer, being eligible for first line chemotherapy;
•2. Age > 65 years;
•3. Non-measurable (evaluable) or measurable disease (according to RECIST criteria). In case of evaluable (non-measurable) disease, the presence of an increased tumormarker (either Ca15.3, Ca125, CEA, whatever is increased) is obligatory;
•4. ECOG performance score of 0 – 2
•5. May be HER-2/neu positive or negative
•6. Adequate bone marrow function, acceptable renal function and acceptable liver functions
•7. Normal baseline LVEF by MUGA scan according to the institutional limits, no prior history of myocardial infarction within < 6 months, no cardiac insufficiency (NYHA Class II or greater), no clinical evidence of congestive heart failure (CHF) or myocardial infarct (MI) within less than six months
•8. Written informed consent
•9. Patients being willing and able to complete study questionnaires in the Dutch language.

•1. No anthracyclin-resistant disease (defined as development of locally recurrent or metastatic disease while on adjuvant anthracycline therapy, or relapse within 12 months after completion of anthracycline therapy) and adjuvant cumulative anthracycline dose (if given in the adjuvant setting) of < 240 mg/m2 of doxorubicin (or < 450 mg/m2 of epirubicin);
•2. Evidence of MBC in the central nervous system, unless previously treated and being asymptomatic/controlled for at least 3 months;
•3. No current or previous chemotherapy for metastatic breast cancer (unless received in the adjuvant setting; patient may also have received hormonal and/or trastuzumab therapy for metastatic disease, as long as this therapy has been stopped for over 2 weeks);
•4. No other malignancy within the previous 5 years (except adequately treated in situ carcinoma of cervix, or basal cell carcinoma);
•5. No abuse of drugs, alcohol, pharmaceuticals, competing with adequate compliance in this study.

发起方

Borstkanker Onderzoeks Groep (BOOG)Plesmanlaan 1251066 CX Amsterdam00-31-(0)20-346 2547boog@ikca.nl