A Randomised Comparative Trial of Infusional ECF (Epirubicin, Cisplatin and 5-fluorouracil) versus Conventional AC (Adriamycin, Cyclophosphamide) as Primary (Neoadjuvant) Chemotherapy for Patients with at Least 3cm Diameter Early Breast Cancer

ISRCTN	ISRCTN19831176
DOI	https://doi.org/10.1186/ISRCTN19831176
Secondary identifying numbers	ICR/TOPIC

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Dr - -
Scientific

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

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title
Study acronym	TOPIC I
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. Infusional ECF Regimen: Chemotherapy, ECF (epirubicin, cisplatin and 5-fluorouracil) treatment continuing 3 weekly for six courses 2. AC Regimen: Chemotherapy, AC (adriamycin, cyclophosphamide) treatment continuing 3 weekly for six courses
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Infusional ECF (Epirubicin, Cisplatin and 5-fluorouracil) versus Conventional AC
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/10/1993
Completion date	01/02/1999

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target number of participants	426 patients from 18 centres, in active follow-up
Key inclusion criteria	1. Histologically or cytologically proven breast cancer 2. Aged <70 years 3. Potentially operable primary breast cancer more than 3 cm in diameter 4. Patients assessed as being competent to learn to look after Infumed or Graseby pump 5. World Health Organisation (WHO) performance status 0-1 6. No evidence of metastatic disease 7. Adequate haematological function 8. Glomerular filtration rate of at least 60 ml/min 9. No other serious uncontrolled medical condition 10. No other malignancy, except carcinoma in situ of the cervix or basal cell carcinoma of the skin
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/10/1993
Date of final enrolment	01/02/1999

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

The Institute of Cancer Research (UK)
Government

123 Old Brompton Road
London
SW7 3RP
United Kingdom

Website	http://www.icr.ac.uk
"ROR"	https://ror.org/043jzw605

Research organisation

Institute of Cancer Research (UK)
Government organisation / National government

Alternative name(s): Institute of Cancer Research - CIHR, CIHR Institute of Cancer Research, L'Institut du cancer, Institut du cancer, ICR - CIHR, ICR, IC
Location: Canada

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2004		Yes	No