|
ISRCTN
|
ISRCTN98335268
|
|
ClinicalTrials.gov identifier
|
|
|
Public 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
|
|
Scientific title
|
|
|
Acronym
|
N/A
|
|
Serial number at source
|
ICCG/9/91
|
|
Study hypothesis
|
Not provided at time of registration
|
|
Ethics approval
|
Not provided at time of registration
|
|
Study design
|
Randomised controlled trial
|
|
Countries of recruitment
|
United Kingdom
|
|
Disease/condition/study domain
|
Breast cancer
|
|
Participants - 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
|
|
Participants - exclusion criteria
|
Not provided at time of registration
|
|
Anticipated start date
|
01/01/2000
|
|
Anticipated end date
|
31/12/2002
|
|
Status of trial
|
Completed
|
|
Patient information material
|
|
|
Target number of participants
|
Not provided at time of registration
|
|
Interventions
|
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.
|
|
Primary outcome measure(s)
|
Not provided at time of registration
|
|
Secondary outcome measure(s)
|
Not provided at time of registration
|
|
Sources of funding
|
Pharmacia and Upjohn (UK)
|
|
Trial website
|
|
|
Publications
|
|
|
Contact name
|
Dr
-
-
|
|
Address
|
UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
|
|
City/town
|
London
|
|
Zip/Postcode
|
NW1 2DA
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0) 20 7670 4723
|
|
Fax
|
+44 (0) 20 7670 4818
|
|
Email
|
register@ctu.mrc.ac.uk
|
|
Sponsor
|
Pharmacia Ltd (UK)
|
|
Address
|
Davy Avenue
|
|
City/town
|
Milton Keynes
|
|
Zip/Postcode
|
MK5 8PH
|
|
Country
|
United Kingdom
|
|
Tel
|
+44 (0)1908 661101
|
|
Fax
|
+44 (0)1908 690091
|
|
Email
|
|
|
Sponsor website:
|
http://www.pharmacia.com
|
|
Date applied
|
19/08/2002
|
|
Last edited
|
14/05/2008
|
|
Date ISRCTN assigned
|
19/08/2002
|
