An Open Randomised Trial of Zoladex versus CMF as Adjuvant Therapy in the Management of Node Positive Stage II Breast Cancer in Pre/Peri-Menopausal Women Aged 50 Years or Less
| ISRCTN | ISRCTN15682734 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN15682734 |
| Secondary identifying numbers | ZEN2802 |
- Submission date
- 19/08/2002
- Registration date
- 19/08/2002
- Last edited
- 13/11/2012
- 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 |
| Scientific title | |
| 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 |
| Intervention | Patients are randomised to one of two treatment arms: 1. Arm A: Zoladex, 3.6 mg given subcutaneously every 28 days for 2 years or until a treatment endpoint is reached. 2. Arm B: Chemotherapy with cyclophosphamide, methotrexate and 5-fluorouracil (CMF) repeated every 28 days for six cycles. |
| Intervention type | Other |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/1995 |
| Completion date | 31/12/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | Not provided at time of registration |
| Key inclusion criteria | 1. Pre- or peri-menopausal 2. Node positive stage II breast cancer, at entry to study, consisting of: 2.1. Histologically proven operable invasive breast cancer 2.2. Pathologically involved lymph nodes c. No evidence of metastatic disease 3. No previous systemic therapy for breast cancer 4. Adequate hepatic, renal and haematological function 5. No bilateral oophorectomy or radiotherapy to the ovaries 6. No concurrent or previous malignancy, except squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/1995 |
| Date of final enrolment | 31/12/1996 |
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
AstraZeneca Clinical Research Group (UK)
Industry
Industry
10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom
| Website | http://www.astrazeneca.co.uk |
|---|---|
"ROR" |
https://ror.org/04r9x1a08 |
Funders
Funder type
Industry
AstraZeneca Pharmaceuticals
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 | 15/12/2002 | Yes | No |
