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

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Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
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
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Doxorubicin (adriamycin), cyclophosphamide, thiotepa, methotrexate, 5-fluorouracil
Primary outcome measure(s)	Not provided at time of registration
Key secondary outcome measure(s)	Not provided at time of registration
Completion date	30/06/1999

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Not Specified
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

MRC Clinical Trials Unit

London
NW1 2DA
United Kingdom

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

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