Condition category
Cancer
Date applied
01/07/2001
Date assigned
01/07/2001
Last edited
01/02/2012
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

NCT00002460

Protocol/serial number

CRCBCTG9

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

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Breast cancer

Intervention

Following surgery (local excision or mastectomy) with or without additional primary therapy patients are randomised to either:
1. Group A: No further treatment.
2. Group B: Adjuvant tamoxifen, 20 mg daily for 2 years. Treatment to start as soon as possible following surgery.
3. Group C: Zoladex, 3.6 mg depot/month for 2 years. Treatment to start as soon as possible following surgery.
4. Group D: Tamoxifen 20 mg daily and Zoladex 3.6 mg depot/month both for 2 years. Treatment to start as soon as possible following surgery.

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

01/01/1994

Overall trial end date

22/03/1999

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged < 50 years
2. Operable breast cancer, that is clinically T1,T2 or T3,N0 or N1,M0
3. No evidence of metastases
4. Normal renal, hepatic function and full blood counts, including platelets
5. Patients with bilateral tumours are not eligible
6. No concomitant hormonal therapy or chemotherapy
7. No hormonal therapy in the last 6 weeks
8. No previous malignancy, except basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix adequately cone biopsied
9. Fit to receive either treatment

Participant type

Patient

Age group

Not Specified

Gender

Female

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/1994

Recruitment end date

22/03/1999

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Cancer Research UK (CRUK) (UK)

Sponsor details

PO Box 123
Lincoln's Inn Fields
London
WC2A 3PX
United Kingdom
+44 (0)207 317 5186
kate.law@cancer.org.uk

Sponsor type

Charity

Website

http://www.cancer.org.uk

Funders

Funder type

Charity

Funder name

Cancer Research UK

Alternative name(s)

CRUK

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

United Kingdom

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. 1989 protocol in http://www.ncbi.nlm.nih.gov/pubmed/2613207

Publication citations

  1. Protocol

    Baum M, Houghton J, Riley DL, Melhuish PB, Cancer Research Campaign Adjuvant Breast Trial for patients under 50., Horm. Res., 1989, 32 Suppl 1, 226-9; discussion 230.

Additional files

Editorial Notes