An adjuvant randomised study comparing standard dose FE[50]C with a higher dose FE[75]C and evaluating the additional benefit of sequential hormone therapy in node positive pre-menopausal primary breast cancer
| ISRCTN | ISRCTN98335268 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN98335268 |
| Protocol serial number | ICCG/9/91 |
| Sponsor | Pharmacia Ltd & Upjohn (UK) |
| Funder | Pharmacia and Upjohn (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 05/05/2016
- 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
Dr - -
Scientific
Scientific
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | An adjuvant randomised study comparing standard dose FE[50]C with a higher dose FE[75]C and evaluating the additional benefit of sequential hormone therapy in node positive pre-menopausal primary breast cancer |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | 1. Regimen A: chemotherapy, FE[50]C repeated every three weeks for eight cycles followed by hormonal manipulation. 2. Regimen B: chemotherapy, FE[50]C repeated every three weeks for eight cycles. 3. Regimen C: chemotherapy, FE[75]C repeated every three weeks for eight cycles followed by hormonal manipulation. 4. Regimen D: chemotherapy, FE[75]C repeated every three weeks for eight cycles. Patient's menopausal status to be assessed post chemotherapy. Pre-menopausal patients randomised to receive hormonal manipulation are to receive a long acting Gonadotrophin Releasing Hormone (GnRH), goserelin or equivalent, every 28 days for three years. Post-menopausal patients randomised to receive hormonal manipulation are to receive tamoxifen 20 mg daily for three years. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Key inclusion criteria | 1. Histologically proven non-metastatic breast cancer 2. Received optimal axillary node sampling (at least seven nodes must be in the axillary dissection) 3. Between one and five histologically involved axillary nodes 4. Pre-menopausal that is: a. Last menstrual period within one year of randomisation, or b. Oestrogen and Follicle Stimulating Hormone (FSH)/Luteinising Hormone (LH) levels compatible with ovarian function, particularly if the patient has had a hysterectomy 5. Adequate renal, hepatic and haematological function 6. No bilateral malignancy 7. No inflammatory breast carcinoma 8. No clinically positive contralateral axillary or supraclavicular nodes, unless there is biopsy evidence that these are not involved with the tumour 9. No ulceration or infiltration of the skin 10. No satellite breast or parasternal nodules 11. No oedema of the arm 12. No medical contraindications to treatment protocols |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2000 |
| Date of final enrolment | 31/12/2002 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 | 01/06/2016 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
05/05/2016: Publication reference added.
11/01/2016: Publication reference added.
