Condition category
Cancer
Date applied
19/08/2002
Date assigned
19/08/2002
Last edited
30/11/2015
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

NCT00002579

Protocol/serial number

SCTN-BR9403; EORTC 10901

Study information

Scientific title

Tamoxifen following combination chemotherapy in treating women with operable invasive breast cancer

Acronym

Study hypothesis

The aim of the trial is to assess whether adjuvant Tamoxifen given after post operative chemotherapy for primary breast cancer adds to the disease free at overall survival advantage which results from adjuvant chemotherapy alone. In Scotland, Tamoxifen will be given for 5 years whereas in other countries the duration will be 3 years. (Part of the Scottish Chemo-Endocrine Trial D (EORTC Trial 10901) - UK CCCR ABC trial framework)

As of 05/08/09 this record has been extensively updated. All updates can be found under the relavent field with the above update date. Please also note the start and end dates of this trial have been changed from 01/01/1999 and 15/05/1999 respectively. Funding information has been corrected from Scottish Therapy Network to Scottish Cancer Therapy Network.

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

Treatment

Patient information sheet

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

Condition

Breast cancer

Intervention

Current information as of 05/08/09:
Patients are stratified by age and by participating institution. All patients undergo surgical resection with local radiation therapy, as appropriate. Within 4 weeks of surgery, patients receive cyclophosphamide, methotrexate, and fluorouracil (CMF) every 3 weeks for 6 courses. Radiotherapy is given within 4 weeks of completion of CMF. Before beginning the last course of CMF, patients are randomized to receive either oral tamoxifen daily for 5 years or no further therapy. Patients are followed every 6 months for 5 years, then yearly. Hormone therapy is prohibited except as specified above and except for short-term hormone replacement therapy for severe unresponsive menopausal symptoms.

Initial information at time of registration:
All patients receive chemotherapy, CMF (Cyclophosphamide, Methotrexate and 5-Fluorouracil) repeated every three weeks for six cycles.

Patients are then randomised to one of two treatment groups:
1. Group A: Tamoxifen, 20 mg daily for five years
2. Group B: No further treatment

Intervention type

Drug

Phase

Not Specified

Drug names

Tamoxifen, cyclophosphamide, methotrexate, and fluorouracil

Primary outcome measures

(Added 05/08/09) Disease free at overall survival

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/07/1998

Overall trial end date

30/06/2004

Reason abandoned

Eligibility

Participant inclusion criteria

1. Pre- or post-menopausal
2. Histologically confirmed palpable unilateral invasive breast cancer of TNM (Tumour, Node, Metastasis) stages T1-T3, N0-N1 and M0, for whom adjuvant chemotherapy is considered an essential part of initial therapy
3. A bilateral mammography to have been performed within the year prior to randomisation

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

(Added 05/08/09) Approximately 2,000 patients will be required. Data on patients entered in Scotland as part of this study will be pooled with data from the EORTC-10901 study.

Participant exclusion criteria

1. Patients with in situ carcinoma only, including Paget's disease of the nipple without underlying invasion
2. Presence of distant metastases
3. Patients currently receiving tamoxifen
4. Prior history of other malignancy, other than adequately treated basal or squamous cell carcinoma of skin
5. Other contraindications to treatment

Recruitment start date

01/07/1998

Recruitment end date

30/06/2004

Locations

Countries of recruitment

United Kingdom

Trial participating centre

UKCCCR Register Co-ordinator
London
NW1 2DA
United Kingdom

Sponsor information

Organisation

Scottish Cancer Therapy Network (UK)

Sponsor details

Trinity Park House
South Trinity Road
Edinburgh
EH5 3SQ
United Kingdom

Sponsor type

Research organisation

Website

Funders

Funder type

Other

Funder name

Scottish Cancer Therapy Network (UK)

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

Publication citations

Additional files

Editorial Notes

30/11/2015: No publications found in PubMed.