Contact information
Type
Scientific
Primary contact
Mrs Siena van der Wilt, PhD
ORCID ID
Contact details
Breast Cancer Study Group (Borstkanker Onderzoeks Groep [BOOG])
Plesmanlaan 125
Amsterdam
1066 CX
Netherlands
+31 (0)20 346 2547
boog@ikca.nl
Additional identifiers
EudraCT number
2006-002046-10
ClinicalTrials.gov number
Protocol/serial number
2006-02
Study information
Scientific title
Acronym
OMEGA
Study hypothesis
This trial aims to demonstrate the superiority of Polyethylene Glycol (PEG) doxorubicin (with three months) over capecitabine as first line chemotherapy in patients with metastatic breast cancer.
Ethics approval
Approval received from the local medical ethics committee (Medisch Ethische Toetsingscommissie [METC] Noord-Holland) on the 14/07/2006 (ref: METC-registration M06-015, CCMO-registration P06.0785L).
Study design
Randomised, open labelled, parallel group, multicentre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Metastatic breast cancer in elderly patients
Intervention
Six cycles of intravenous pegylated liposomal doxorubicin (45 mg/m^2 every four weeks) compared to eight cycles of oral capecitabine (2000 mg/m^2, days one to 14 every three weeks). Questionnaires regarding Quality of Life (QoL) and a Geriatric Assessment tool (GA) will also be incorporated.
Intervention type
Drug
Phase
Phase III
Drug names
Pegylated liposomal doxorubicin and capecitabine
Primary outcome measure
To compare the Progression Free Survival (PFS) in elderly patients (greater than 65 years of age) with metastatic breast cancer treated with either PEG doxorubicin or capecitabine as first line chemotherapy. The 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 measures
1. To compare the objective response rates (Complete Response [CR] and Partial Response [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 Stable Disease [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
Overall trial start date
15/02/2007
Overall trial end date
15/08/2008
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Female patients with metastatic breast cancer, being eligible for first line chemotherapy
2. Aged greater than 65 years
3. Non-measurable (evaluable) or measurable disease (according to Response Evaluation Criteria in Solid Tumours [RECIST] criteria). In case of evaluable (non-measurable) disease, the presence of an increased tumour marker (either Cancer antigen 15.3 [Ca15.3], Cancer antigen-125 [Ca125], Carcinoembryonic Antigen [CEA], whatever is increased) is obligatory
4. European Cooperative Oncology Group (ECOG) performance score of zero to two
5. May be Human Epidermal growth factor Receptor 2 (HER-2/neu) positive or negative
6. Adequate bone marrow function, acceptable renal function and acceptable liver functions
7. Normal baseline Left Ventricular Ejection Fraction (LVEF) by Multiple Gated Acquisition (MUGA) scan according to the institutional limits, no prior history of myocardial infarction within less than six months, no cardiac insufficiency (New York Heart Association [NYHA] Class II or greater), no clinical evidence of Congestive Heart Failure (CHF) or Myocardial Infarction (MI) within less than six months
8. Written informed consent
9. Patients being willing and able to complete study questionnaires in the Dutch language
Participant type
Patient
Age group
Senior
Gender
Female
Target number of participants
154
Participant 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 less than 240 mg/m^2 of doxorubicin (or less than 450 mg/m^2 of epirubicin)
2. Evidence of Metastatic Breast Cancer (MBC) in the central nervous system, unless previously treated and being asymptomatic/controlled for at least three 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 two weeks)
4. No other malignancy within the previous five 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
Recruitment start date
15/02/2007
Recruitment end date
15/08/2008
Locations
Countries of recruitment
Netherlands
Trial participating centre
Breast Cancer Study Group (Borstkanker Onderzoeks Groep [BOOG])
Amsterdam
1066 CX
Netherlands
Sponsor information
Organisation
Breast Cancer Study Group (Borstkanker Onderzoeks Groep [BOOG]) (The Netherlands)
Sponsor details
P.O. Box 9236
Amsterdam
1006 AE
Netherlands
+31 (0)20 346 2547
boog@ikca.nl
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Breast Cancer Study Group (Borstkanker Onderzoeks Groep [BOOG]) (The Netherlands)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24504445
Publication citations
-
Results
Smorenburg CH, de Groot SM, van Leeuwen-Stok AE, Hamaker ME, Wymenga AN, de Graaf H, de Jongh FE, Braun JJ, Los M, Maartense E, van Tinteren H, Nortier JW, Seynaeve C, A randomized phase III study comparing pegylated liposomal doxorubicin with capecitabine as first-line chemotherapy in elderly patients with metastatic breast cancer: results of the OMEGA study of the Dutch Breast Cancer Research Group BOOG., Ann. Oncol., 2014, 25, 3, 599-605, doi: 10.1093/annonc/mdt588.