A randomised, 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

ISRCTN	ISRCTN11114726
DOI	https://doi.org/10.1186/ISRCTN11114726
EudraCT/CTIS number	2006-002046-10
Secondary identifying numbers	2006-02

Submission date: 07/03/2007
Registration date: 07/03/2007
Last edited: 12/02/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Mrs Siena van der Wilt, PhD
Scientific

Breast Cancer Study Group (Borstkanker Onderzoeks Groep [BOOG])
Plesmanlaan 125
Amsterdam
1066 CX
Netherlands

Phone	+31 (0)20 346 2547
Email	boog@ikca.nl

Study information

Study design	Randomised, open labelled, parallel group, multicentre trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Scientific title
Study acronym	OMEGA
Study objectives	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(s)	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).
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Phase III
Drug / device / biological / vaccine name(s)	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 study start date	15/02/2007
Completion date	15/08/2008

Eligibility

Participant type(s)	Patient
Age group	Senior
Sex	Female
Target number of participants	154
Key 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
Key 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
Date of first enrolment	15/02/2007
Date of final enrolment	15/08/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

Breast Cancer Study Group (Borstkanker Onderzoeks Groep [BOOG])

Amsterdam
1066 CX
Netherlands

Sponsor information

Breast Cancer Study Group (Borstkanker Onderzoeks Groep [BOOG]) (The Netherlands)
Research organisation

P.O. Box 9236
Amsterdam
1006 AE
Netherlands

Phone	+31 (0)20 346 2547
Email	boog@ikca.nl
"ROR"	https://ror.org/04cr37s66

Funders

Funder type

Research organisation

Breast Cancer Study Group (Borstkanker Onderzoeks Groep [BOOG]) (The Netherlands)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2014		Yes	No