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
Secondary identifying numbers C93
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

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleA multicentre randomised study of dose-intensive chemotherapy as primary treatment in a multimodality approach for locally advanced or inflammatory breast cancer
Study objectivesAdded 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) studiedBreast cancer
Intervention1. 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Cyclophosphamide, epirubicin, 5-fluorouracil, etoposide, granulocyte-colony stimulating factor (G-CSF), trimethoprim-sulphamethoxazole and tamoxifen
Primary outcome measureAdded 06/08/2009:
1. Response rate
2. Survival
3. Quality of life
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1996
Completion date04/04/1996

Eligibility

Participant type(s)Patient
Age groupAdult
SexFemale
Target number of participants400 (added 06/08/2009)
Key inclusion criteria1. 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 criteriaDoes not match inclusion criteria
Date of first enrolment01/01/1996
Date of final enrolment04/04/1996

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

MRC Clinical Trials Unit
London
NW1 2DA
United Kingdom

Sponsor information

European Organisation for Research and Treatment of Cancer (EORTC) (Belgium)
Research organisation

83, Avenue E. Mounier
Bte 11
Brussels
B-1200
Belgium

Phone +32 (0)2 774 16 41
Email eortc@eortc.be
Website http://www.eortc.be
ROR logo "ROR" https://ror.org/034wxcc35

Funders

Funder type

Research organisation

European Organisation for Research and Treatment of Cancer
Private sector organisation / Other non-profit organizations
Alternative name(s)
EORTC
Location
Belgium
National Cancer Institute of Canada (NCIC) (Canada)

No information available

Swiss Institute for Applied Cancer Research (Switzerland)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan