Prospective randomised evaluation of high-intensity chemotherapy with peripheral blood progenitor support in patients with high risk breast cancer

ISRCTN	ISRCTN62673495
DOI	https://doi.org/10.1186/ISRCTN62673495
Secondary identifying numbers	BR9405

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 15/12/2015

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

Dr - -
Scientific

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

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Prospective randomised evaluation of high-intensity chemotherapy with peripheral blood progenitor support in patients with high risk breast cancer
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. High Dose Arm: Induction chemotherapy with single agent doxorubicin (adriamycin), treatment to be repeated every 3 weeks for four cycles. Induction chemotherapy to be followed by high dose chemotherapy, cyclophosphamide then cyclophosphamide and thiotepa, with stem cell support. 2. Conventional Arm: Induction chemotherapy with single agent doxorubicin, treatment to be repeated every 3 weeks for four cycles followed by conventional cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 3 weeks for eight cycles.
Intervention type	Drug
Pharmaceutical study type(s)
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Doxorubicin (adriamycin), cyclophosphamide, thiotepa, methotrexate, 5-fluorouracil
Primary outcome measure	Not provided at time of registration
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/01/1997
Completion date	30/06/1999

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
Target number of participants	Not provided at time of registration
Key inclusion criteria	1. Aged >18 years (usually <55 years). 2. Histologically proven operable stage II or IIIA breast cancer with an involvement of at least four lymph nodes 3. Eastern Cooperative Oncology Group (ECOG) performance status 0-1 4. Confirmed normal haematological and biochemical parameters 5. Free from overt metastatic disease 6. No other malignancy, except basal cell carcinoma of the skin or in-situ carcinoma of the cervix 7. Fit to receive treatment
Key exclusion criteria	Not provided at time of registration
Date of first enrolment	01/01/1997
Date of final enrolment	30/06/1999

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Sponsor information

Amgen Limited (UK)
Industry

240 Cambridge Science Park
Cambridge
CB4 4WD
United Kingdom

Website	http://www.amgen.com
"ROR"	https://ror.org/02gvvc992

Funders

Funder type

Industry

Amgen (UK)
Government organisation / For-profit companies (industry)

Alternative name(s): Amgen Inc., Applied Molecular Genetics Inc.
Location: United States of America

Results and Publications

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

Editorial Notes

15/12/2015: no publications found on PubMed.