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 measure
(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 (if study stopped)
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
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
Basic results (scientific)
Publication list