A Randomised Trial of Adriamycin and Taxotere vs. Adriamycin and Cyclophosphamide in Breast Cancer
| ISRCTN | ISRCTN15113276 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15113276 |
| Secondary identifying numbers | BR 9809 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 30/05/2012
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Dr - -
Scientific
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 | |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/07/1999 |
| Completion date | 01/07/2002 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 363 (added 12/02/10; see publication) |
| 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 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
NW1 2DA
United Kingdom
Sponsor information
Scottish Cancer Therapy Network (UK)
Research organisation
Research organisation
Trinity Park House
South Trinity Road
Edinburgh
EH5 3SQ
United Kingdom
Funders
Funder type
Research organisation
Scottish Cancer Therapy Network (UK)
No information available
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/05/2005 | Yes | No |
