Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
ZEN2802
Study information
Scientific title
Acronym
Study hypothesis
Not provided at time of registration
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
Condition
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
Phase
Not Specified
Drug names
Primary outcome measure
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/01/1995
Overall trial end date
31/12/1996
Reason abandoned (if study stopped)
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
Not provided at time of registration
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
01/01/1995
Recruitment end date
31/12/1996
Locations
Countries of recruitment
United Kingdom
Trial participating centre
UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom
Sponsor information
Organisation
AstraZeneca Clinical Research Group (UK)
Sponsor details
10 Logie Mill
Beaverbank Office Park
Lovie Green Road
Edinburgh
EH7 4HG
United Kingdom
Sponsor type
Industry
Website
Funders
Funder type
Industry
Funder name
AstraZeneca Pharmaceuticals
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
1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12488406
Publication citations
-
Results
Jonat W, Kaufmann M, Sauerbrei W, Blamey R, Cuzick J, Namer M, Fogelman I, de Haes JC, de Matteis A, Stewart A, Eiermann W, Szakolczai I, Palmer M, Schumacher M, Geberth M, Lisboa B, , Goserelin versus cyclophosphamide, methotrexate, and fluorouracil as adjuvant therapy in premenopausal patients with node-positive breast cancer: The Zoladex Early Breast Cancer Research Association Study., J. Clin. Oncol., 2002, 20, 24, 4628-4635.