High Dose Therapy in Poor-Risk Primary Breast Cancer
| ISRCTN | ISRCTN52623943 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN52623943 |
| Protocol serial number | ICCG/10/92 |
| Sponsor | Amgen Limited (UK) |
| Funder | Amgen (UK) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 26/03/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
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 |
| Scientific title | High Dose Therapy in Poor-Risk 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, 5-fluorouracil, epirubicin and cyclophosphamide (FEC), one 3 week cycle, then FEC repeated every 4 weeks for five cycles. 2. Regimen B: Chemotherapy, FEC one 3 week cycle, then FEC repeated every 4 weeks for five cycles followed by high dose therapy with cyclophosphamide, thiotepa and carboplatin and peripheral blood stem cell support. |
| Intervention type | Other |
| Primary outcome measure(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 28/09/2001 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Key inclusion criteria | 1. Complete prior resection of tumour and axillary node clearance 2. Histologically proven T1-T4 primary breast cancer with at least four involved nodes in the axilla 3. Adequate local therapy as defined in the protocol 4. Aged <60 years 5. No previous malignancy or evidence of metastatic disease 6. Fit to receive treatment |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1999 |
| Date of final enrolment | 28/09/2001 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
UKCCCR Register Co-ordinator
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 |
Editorial Notes
26/03/2020: No publications found. All search options exhausted.
