Condition category
Cancer
Date applied
07/03/2007
Date assigned
07/03/2007
Last edited
12/02/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.ikcnet.nl

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 measures

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

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

Results - basic reporting

Publication summary

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24504445

Publication citations

  1. 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.

Additional files

Editorial Notes