search  
 


Home

Who are we?

Why
register?


Signup for
registration


Online registration

Log in to register
your trial


Search a trial

NRT en CCMO

Contact

NEDERLANDS





MetaRegister
van CCT (UK)


ISRCTN-Register
van CCT (UK)


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.


- candidate number2452
- NTR NumberNTR897
- ISRCTNISRCTN11114726
- Date ISRCTN created7-mrt-2007
- date ISRCTN requested6-mrt-2007
- Date Registered NTR9-feb-2007
- Secondary IDs2006-02 
- Public TitleA 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.
- Scientific TitleA 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.
- ACRONYMOMEGA
- hypothesisThis trial aims to demonstrate the superiority of PEG doxorubicin (with 3 months) over capecitabine as first line chemotherapy in patients with metastatic breast cancer.
- Healt Condition(s) or Problem(s) studiedMetastatic breast cancer, Elderly patients
- Inclusion criteria1. 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.
- Exclusion criteria1. 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.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupParallel
- Type-
- Studytypeintervention
- planned startdate 15-feb-2007
- planned closingdate15-aug-2008
- Target number of participants154
- Interventions6 cycles of intravenous pegylated liposomal doxorubicin (q 4 weeks) compared to 8 cycles of oral capecitabine (q 3 weeks).
- Primary outcomeTo compare the progression free survival (PFS) in elderly patients (> 65 years of age) with metastatic breast cancer treated with either PEG doxo or capecitabine as first line chemotherapy. Kaplan-Meier method will be used to estimate the distribution of overall time to disease progression (TTP) for each treatment and the two-sided log-rank test with significance level of 0.05 will be used to compare the TTP distribution between the two treatments.
- Secondary outcome1. To compare the objective response rates (CR and PR, according to RECIST criteria) between the two treatment regimens, given as first line chemotherapy in MBC in elderly patients; 2. To compare the rate of clinical benefit (CR, PR, and SD over 24 weeks); 3. To compare the overall survival between the two treatment regimens; 4. To evaluate the relation of response and toxicity of the respective chemotherapy regimen with co-morbidity and co-medication.
- Timepoints
- Trial web sitehttp://www.ikcnet.nl
- statusplanned
- CONTACT FOR PUBLIC QUERIES Borstkanker Onderzoeks Groep (BOOG)
- CONTACT for SCIENTIFIC QUERIESDr. C. Seynaeve
- Sponsor/Initiator Breast Cancer Study Group (BOOG)
- Funding
(Source(s) of Monetary or Material Support)
Breast Cancer Study Group (BOOG)
- PublicationsN/A
- Brief summaryFemale patients with metastatic breast cancer, being 65 years or older, who are eligible for first line chemotherapy will be randomized between pegylated liposomal doxorubicin (PEG doxo, 45 mg/m2) (given intravenously, each 28 days), and capecitabine (2000 mg/m2, days 1-14, to be repeated every 21 days). Questionnaires regarding Quality of Life (QoL) and a geriatric assessment tool (GA) will be incorporated to further investigate the contribution and role of this type of assessments aiming to improve the clinical evaluation of the condition and/or frailty of the individual patient and quality of life during chemotherapy in elderly metastatic breast cancer patients.
- Main changes (audit trail)
- RECORD9-feb-2007 - 7-mrt-2007


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl