A trial to study the place of surgery in elderly women with breast cancer treated by tamoxifen

ISRCTN ISRCTN72493595
DOI https://doi.org/10.1186/ISRCTN72493595
Secondary identifying numbers CRCBCTG6
Submission date
01/07/2001
Registration date
01/07/2001
Last edited
13/06/2014
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

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

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific title
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedBreast
Intervention1. Group A: Optimal surgery plus tamoxifen, 20 mg twice daily
2. Group B: Tamoxifen, 20 mg twice daily

All patients receive tamoxifen until there is evidence of progressive disease.
Intervention typeOther
Primary outcome measureNot provided at time of registration
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/1995
Completion date31/12/1997

Eligibility

Participant type(s)Patient
Age groupSenior
SexFemale
Target number of participantsNot provided at time of registration
Key inclusion criteria1. Aged >70 years
2. Histological, cytological or unequivocal mammographic confirmation of carcinoma of the breast
3. Operable breast cancer
4. No metastases
5. No previous malignancy, except skin cancer or adequately treated in situ carcinoma of the cervix
6. Fit and willing to receive either treatment
Key exclusion criteria1. Patients with bilateral breast cancer are excluded
2. Patients with Paget's disease without a palpable lump, in situ carcinoma or an impalpable lesion shown on mammograph alone are excluded
Date of first enrolment01/01/1995
Date of final enrolment31/12/1997

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

UK Co-ordinating Committee for Cancer Research (UKCCCR)
Government

MRC Clinical Trials Unit
222 Euston Road
London
NW1 2DA
United Kingdom

ROR logo "ROR" https://ror.org/054225q67

Funders

Funder type

Not defined

Not provided at time of registration

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 01/08/1997 Yes No