Pilot Phase III immunotherapy study in early breast cancer patients using oxidized mannan-MUC1
| ISRCTN | ISRCTN71711835 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN71711835 |
| Secondary identifying numbers | EOF-27581 |
- Submission date
- 17/03/2006
- Registration date
- 24/03/2006
- Last edited
- 08/05/2008
- 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
Contact information
Prof Vasso Apostolopoulos
Scientific
Scientific
The Austin Research Institute
Studley Road
Heidelberg
3084
Australia
| Phone | +61 (0)392870666 |
|---|---|
| v.apostolopoulos@ari.unimelb.edu.au |
Study information
| Study design | A randomized double-blinded pilot study. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Prevention |
| Scientific title | |
| Study acronym | IFCM9 |
| Study objectives | To evaluate patients with early/minimal residual disease of breast cancer after injection with oxidized mannan-MUC1. |
| Ethics approval(s) | Greek ethics committee approval 26 September 1997 |
| Health condition(s) or problem(s) studied | 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase III |
| Drug / device / biological / vaccine name(s) | 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 study start date | 13/12/1997 |
| Completion date | 18/06/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 31 |
| Key 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 |
| Key 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 |
| Date of first enrolment | 13/12/1997 |
| Date of final enrolment | 18/06/2003 |
Locations
Countries of recruitment
- Australia
- Greece
Study participating centre
The Austin Research Institute
Heidelberg
3084
Australia
3084
Australia
Sponsor information
Prolipsis Medical Center (Greece)
Hospital/treatment centre
Hospital/treatment centre
Sevastias 3 Street
Athens
11528
Greece
| Phone | +30 (0)210 7483110 |
|---|---|
| helaca@hol.gr |
Funders
Funder type
Research organisation
The Austin Research Institute, Heidelberg VIC Australia and Prolipsis Medical Center, Athens Greece.
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: | 01/04/2006 | Yes | No |
