Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
13/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr - -

ORCID ID

Contact details

UKCCCR Register Co-ordinator
MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

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 measures

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

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

http://www.astrazeneca.co.uk

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

Results - basic reporting

Publication summary

1. 2002 results in http://www.ncbi.nlm.nih.gov/pubmed/12488406

Publication citations

  1. 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.

Additional files

Editorial Notes