A Randomised Trial of Adriamycin and Taxotere vs. Adriamycin and Cyclophosphamide in Breast Cancer

ISRCTN	ISRCTN15113276
DOI	https://doi.org/10.1186/ISRCTN15113276
Protocol serial number	BR 9809
Sponsor	Scottish Cancer Therapy Network (UK)
Funder	Scottish Cancer Therapy Network (UK)

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	Added 12/02/10: To compare the clinical and pathologic response rates of doxorubicin and cyclophosphamide (AC) with doxorubicin and docetaxel (AD) as primary chemotherapy in women with primary or locally advanced breast cancer. Please note that as of 12/02/10 this record has been updated. All changes can be found in the relevant field with the above update date.
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Breast cancer
Intervention	1. Adriamycin 50 mg/m^2 intravenous (iv) 3 weekly + taxotere 75 mg/m^2 iv 3 weekly (NB Taxotere must be administered prior to Adriamycin) 2. Adriamycin (60 mg/m^2 iv) 3 weekly + cyclophosphamide (600 mg/m^2 iv) weekly. Maximum of 6 cycles of combination chemotherapy.
Intervention type	Drug
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Doxorubicin (Adriamycin®), docetaxel (Taxotere®), cyclophosphamide
Primary outcome measure(s)	Added 12/02/10: Overall (complete and partial) clinical response rates
Key secondary outcome measure(s)	Added 12/02/10: Number of relapses
Completion date	01/07/2002

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	Female
Target sample size at registration	363
Key inclusion criteria	1. Histologically proven breast cancer (BrCa) 2. Potentially operable disease >3cm diameter, locally advanced disease (including T4 lesions) or inflammatory BrCa 3. Patients older then 18 years
Key exclusion criteria	Does not match inclusion criteria
Date of first enrolment	01/07/1999
Date of final enrolment	01/07/2002

UKCCCR Register Co-ordinator

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

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2005		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes