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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ISRCTN |
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Last refreshed on:
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13 January 2015 |
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Main ID: |
ISRCTN78982321 |
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Date of registration:
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19/08/2002 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A multicentre randomised study of dose-intensive chemotherapy as primary treatment in a multimodality approach for locally advanced or inflammatory breast cancer
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Scientific title:
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Date of first enrolment:
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01/01/1996 |
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Target sample size:
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400 |
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Recruitment status: |
Completed |
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URL:
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http://isrctn.com/ISRCTN78982321 |
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Study type:
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Interventional |
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Study design:
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Randomised controlled trial (Treatment)
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Phase:
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Countries of recruitment
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United Kingdom
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Contacts
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Name:
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Address:
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Telephone:
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Email:
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Affiliation:
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Name:
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-
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Address:
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UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
NW1 2DA
London
United Kingdom |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Exclusion criteria: Does not match inlcusion criteria
Age minimum:
Age maximum:
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast cancer
Cancer
Malignant neoplasm of breast
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Intervention(s)
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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.
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Primary Outcome(s)
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Added 06/08/09:
1. Response rate
2. Survival
3. Quality of life
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Secondary Outcome(s)
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Not provided at time of registration
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Source(s) of Monetary Support
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European Organisation for Research and Treatment of Cancer (EORTC) (Belgium), National Cancer Institute of Canada (NCIC) (Canada), Swiss Institute for Applied Cancer Research (Switzerland)
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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