Scottish Chemo-Endocrine Trial D

ISRCTN	ISRCTN43697410
DOI	https://doi.org/10.1186/ISRCTN43697410
ClinicalTrials.gov number	NCT00002579
Secondary identifying numbers	SCTN-BR9403; EORTC 10901

Submission date: 19/08/2002
Registration date: 19/08/2002
Last edited: 25/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Cancer

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Tamoxifen following combination chemotherapy in treating women with operable invasive breast cancer
Study objectives	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(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase	Not Specified
Drug / device / biological / vaccine name(s)	Tamoxifen, cyclophosphamide, methotrexate, and fluorouracil
Primary outcome measure	(Added 05/08/09) Disease free at overall survival
Secondary outcome measures	Not provided at time of registration
Overall study start date	01/07/1998
Completion date	30/06/2004

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	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.
Key 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
Key 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
Date of first enrolment	01/07/1998
Date of final enrolment	30/06/2004

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

UKCCCR Register Co-ordinator

London
NW1 2DA
United Kingdom

Sponsor information

Scottish Cancer Therapy Network (UK)
Research organisation

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

Funders

Funder type

Other

Scottish Cancer Therapy Network (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Editorial Notes

25/01/2019: No publications found. All search options exhausted.
30/11/2015: No publications found in PubMed.