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.

• Register: Netherlands Trial Register
• Last refreshed on: 28 April 2013
• Main ID: NTR897
• Date of registration: 09/02/2007
• Primary sponsor: Breast Cancer Study Group (BOOG)
• Public title: 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.
• Scientific title: 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. - OMEGA
• Date of first enrolment: 15/2/2007
• Target sample size: 154
• Recruitment status: pending
• URL: http://www.trialregister.nl/trialreg/admin/rctview.asp?TC=897
• Study type: intervention
• Study design: Randomised: Yes; Masking: None; Control: Not applicable; Group: Parallel; Type: -

Countries of recruitment

The Netherlands

Contacts

• Name: C. Seynaeve

• Name: Borstkanker Onderzoeks Groep (BOOG)

Key inclusion & exclusion criteria

Inclusion criteria: 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.
Exclusion criteria: 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.

Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Metastatic breast cancer, Elderly patients

Intervention(s)

6 cycles of intravenous pegylated liposomal doxorubicin (q 4 weeks) compared to 8 cycles of oral capecitabine (q 3 weeks).

Primary Outcome(s)

To 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 Outcome(s)

1. 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.

Secondary ID(s)

2006-02

ISRCTN11114726

Source(s) of Monetary Support

Breast Cancer Study Group (BOOG)