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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
Results: http://www.ncbi.nlm.nih.gov/pubmed/16776849
Publication citations
-
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.