Additional identifiers
EudraCT/CTIS number
IRAS number
ClinicalTrials.gov number
Protocol/serial number
C93
Study information
Scientific title
A multicentre randomised study of dose-intensive chemotherapy as primary treatment in a multimodality approach for locally advanced or inflammatory breast cancer
Acronym
Study hypothesis
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
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Study setting(s)
Hospital
Study type
Treatment
Patient information sheet
Condition
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
Pharmaceutical study type(s)
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
Added 06/08/2009:
1. Response rate
2. Survival
3. Quality of life
Secondary outcome measures
Not provided at time of registration
Overall study start date
01/01/1996
Overall study end date
04/04/1996
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type(s)
Patient
Age group
Adult
Sex
Female
Target number of participants
400 (added 06/08/2009)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/01/1996
Recruitment end date
04/04/1996
Locations
Countries of recruitment
England, United Kingdom
Study participating centre
MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Sponsor details
83
Avenue E. Mounier
Bte 11
Brussels
B-1200
Belgium
+32 (0)2 774 16 41
eortc@eortc.be
Sponsor type
Research organisation
Website
ROR
Funders
Funder type
Research organisation
Funder name
European Organisation for Research and Treatment of Cancer
Alternative name(s)
EORTC
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
Belgium
Funder name
National Cancer Institute of Canada (NCIC) (Canada)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Swiss Institute for Applied Cancer Research (Switzerland)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Individual participant data (IPD) sharing plan
IPD sharing plan summary
Not provided at time of registration
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|