Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
BR 9809
Study information
Scientific title
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Doxorubicin (Adriamycin®), docetaxel (Taxotere®), cyclophosphamide
Primary outcome measure
Added 12/02/10:
Overall (complete and partial) clinical response rates
Secondary outcome measures
Added 12/02/10:
Number of relapses
Overall trial start date
01/07/1999
Overall trial end date
01/07/2002
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
363 (added 12/02/10; see publication)
Participant exclusion criteria
Does not match inclusion criteria
Recruitment start date
01/07/1999
Recruitment end date
01/07/2002
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Funders
Funder type
Research organisation
Funder name
Scottish Cancer Therapy Network (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2005 results in http://www.ncbi.nlm.nih.gov/pubmed/15860854
Publication citations
-
Results
Evans TR, Yellowlees A, Foster E, Earl H, Cameron DA, Hutcheon AW, Coleman RE, Perren T, Gallagher CJ, Quigley M, Crown J, Jones AL, Highley M, Leonard RC, Mansi JL, Phase III randomized trial of doxorubicin and docetaxel versus doxorubicin and cyclophosphamide as primary medical therapy in women with breast cancer: an anglo-celtic cooperative oncology group study., J. Clin. Oncol., 2005, 23, 13, 2988-2995, doi: 10.1200/JCO.2005.06.156.