A multicentre randomised study of dose-intensive chemotherapy as primary treatment in a multimodality approach for locally advanced or inflammatory breast cancer
| ISRCTN | ISRCTN78982321 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78982321 |
| Protocol serial number | C93 |
| Sponsor | European Organisation for Research and Treatment of Cancer (EORTC) (Belgium) |
| Funders | European Organisation for Research and Treatment of Cancer, National Cancer Institute of Canada (NCIC) (Canada), Swiss Institute for Applied Cancer Research (Switzerland) |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 10/03/2015
- 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
- -
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 | A multicentre randomised study of dose-intensive chemotherapy as primary treatment in a multimodality approach for locally advanced or inflammatory breast cancer |
| Study objectives | Added 06/08/2009: To determine the impact of intensive induction chemotherapy plus g-csf in comparison to a standard regimen on time to distant metastases and overall survival in patients with locally advanced or inflammatory breast cancer. As of 06/08/2009 this trial has been updated. All updates can be found under the relevant field with the above update date. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Breast cancer |
| Intervention | 1. Regimen A: Chemotherapy with cyclophosphamide, epirubicin and 5-fluorouracil (CEF) repeated every four weeks for six courses, unless there is earlier progression, plus oral trimethoprim-sulphamethoxazole (TMP + SMZ) 480 mg twice daily for the duration of chemotherapy. 2. Regimen B: High dose intensity chemotherapy with etoposide and cyclophosphamide plus Granulocyte-Colony Stimulating Factor (G-CSF) repeated every two weeks for six cycles, unless there is earlier progression. If following chemotherapy there is a response or stable disease then patients commence locoregional treatment, either surgery, radiotherapy or both. Following locoregional treatment patients receive maintenance hormonotherapy, tamoxifen 20 mg daily until relapse. |
| Intervention type | Drug |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Cyclophosphamide, epirubicin, 5-fluorouracil, etoposide, granulocyte-colony stimulating factor (G-CSF), trimethoprim-sulphamethoxazole and tamoxifen |
| Primary outcome measure(s) |
Added 06/08/2009: |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 04/04/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 400 |
| Key inclusion criteria | 1. Female patients with histologically confirmed breast cancer in the following subgroups: 1.1. T4 Nx 1.2. Any N2 or N3, M0 1.3. Clinically inflammatory breast carcinoma defined as redness over at least one-third of the breast 1.4. M0 except for ipsilateral supraclavicular nodes 2. No evidence of tumour spread other than as defined above 3. No previous surgical, systemic or radiation treatment for breast cancer, other than biopsy for confirmation of the diagnosis 4. World Health Organisation (WHO) performance status zero to two 5. Adequate renal, hepatic and haematological function 6. No previous or concomitant malignancy except adequately treated squamous or basal cell carcinoma of the skin, or adequately treated cone-biopsied in situ carcinoma of the cervix uteri 7. No significant cardiac disease |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/01/1996 |
| Date of final enrolment | 04/04/1996 |
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 |
