Condition category
Cancer
Date applied
17/03/2006
Date assigned
24/03/2006
Last edited
08/05/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Vasso Apostolopoulos

ORCID ID

Contact details

The Austin Research Institute
Studley Road
Heidelberg
3084
Australia
+61 (0)392870666
v.apostolopoulos@ari.unimelb.edu.au

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

EOF-27581

Study information

Scientific title

Acronym

IFCM9

Study hypothesis

To evaluate patients with early/minimal residual disease of breast cancer after injection with oxidized mannan-MUC1.

Ethics approval

Greek ethics committee approval 26 September 1997

Study design

A randomized double-blinded pilot study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Prevention

Patient information sheet

Condition

Early breast cancer (Stage II)

Intervention

Injection with oxidized mannan-MUC1 versus placebo. This trial tests whether this method of injecting and the stage of the patient receiving vaccine is beneficial in patients against recurrence of breast cancer.

Intervention type

Drug

Phase

Phase III

Drug names

Oxidized mannan-MUC1

Primary outcome measures

After more than 5.5 years from last patient start (8 years from first patient treatment), the recurrence rate in patients receiving the placebo was 4/15 (the expected rate of recurrence in Stage II breast cancer); those receiving immunotherapy had no recurrences (0/16) – a statistically significant result (p = 0.0292). Of the patients receiving oxidized mannan MUC1, 9/13 had measurable antibodies to MUC1 and 4/10 had MUC1 specific T cell responses; none of the placebo treated patients showed an immune response to MUC1.

Secondary outcome measures

The results suggest that in early breast cancer, MUC1 immunotherapy is beneficial, and that a larger Phase III study should be undertaken.

Overall trial start date

13/12/1997

Overall trial end date

18/06/2003

Reason abandoned

Eligibility

Participant inclusion criteria

1. Postmenopausal women (no menstrual period for >12 months)
2. Histological proven adenocarcinoma of the breast treated primarily by modified radical or partial mastectomy and axillary dissection followed by radiation of the residual breast
3. No more than 4 ipsilateral lymph nodes with metastases, not extending into the surrounding tissue and surgical margin free of disease
4. Tumor tissue with positive estrogen receptor
5. Tamoxifen 20 mg daily commencing within three months of breast surgery and to continue for 5 years
6. Adequate bone marrow function (white blood cells >4.0 x 10^9 per litre, haemogoblin >100 g per litre, platelets >100 x 10^9 per litre)
7. Adequate liver function (billirubin <60 mmol/litre i.e. < x 3 upper limit of normal)
8. Adequate renal function (creatinine <140 mmol/litre)
9. Life expectancy >12 weeks
10. Eastern Cooperative Oncology Group (ECOG) status between 0-2 (in bed <50% of daytime)
11. Written informed consent by the patient

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

31

Participant exclusion criteria

1. Known metastatic breast cancer
2. Radiotherapy, chemotherapy, immunotherapy or investigation therapy within the last 4 weeks
3. Previous splenectomy or radiotherapy to spleen
4. Coexisting or previous other malignancies except in situ carcinoma of the cervix or basal cell carcinoma of the skin
5. Active uncontrolled infection
6. Psychiatric, addictive or any disorder which compromises ability to give truly informed consent for participation in this study or comply with the requirements of the study
7. Concurrent systematic corticosteroid treatment
8. Autoimmune disease i.e. rheumatoid arthritis, systematic lupus erythematosus, except autoimmune thyroiditis

Recruitment start date

13/12/1997

Recruitment end date

18/06/2003

Locations

Countries of recruitment

Greece

Trial participating centre

The Austin Research Institute
Heidelberg
3084
Australia

Sponsor information

Organisation

Prolipsis Medical Center (Greece)

Sponsor details

Sevastias 3 Street
Athens
11528
Greece
+30 (0)210 7483110
helaca@hol.gr

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

The Austin Research Institute, Heidelberg VIC Australia and Prolipsis Medical Center, Athens Greece.

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

Results: http://www.ncbi.nlm.nih.gov/pubmed/16776849

Publication citations

  1. Results

    Apostolopoulos V, Pietersz GA, Tsibanis A, Tsikkinis A, Drakaki H, Loveland BE, Piddlesden SJ, Plebanski M, Pouniotis DS, Alexis MN, McKenzie IF, Vassilaros S, Pilot phase III immunotherapy study in early-stage breast cancer patients using oxidized mannan-MUC1 [ISRCTN71711835]., Breast Cancer Res., 2006, 8, 3, R27, doi: 10.1186/bcr1505.

Additional files

Editorial Notes