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29 August 2008
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| [ Print-friendly version ] |
| An open label, randomised multicentre comparative trial of five years adjuvant exemestane treatment versus adjuvant tamoxifen followed by exemestane in postmenopausal women with early breast cancer |
| ISRCTN | ISRCTN75225940 |
| ClinicalTrials.gov identifier | NCT00032136 |
| Public title | An open label, randomised multicentre comparative trial of five years adjuvant exemestane treatment versus adjuvant tamoxifen followed by exemestane in postmenopausal women with early breast cancer |
| Scientific title | |
| Acronym | TEAM - Tamoxifen and Exemestane Adjuvant Multicentre trial |
| Serial number at source | N/A |
| Study hypothesis | To compare the efficacy and tolerability of exemestane versus tamoxifen followed by exemestane given in the adjuvant setting in postmenopausal women with Estrogen Receptor (ER) and/or Progesterone Receptor (PgR)-positive early breast cancer. |
| Ethics approval | Not provided at time of registration |
| Study design | Randomised controlled trial |
| Countries of recruitment | Ireland, United Kingdom |
| Disease/condition/study domain | Breast cancer |
| Participants - inclusion criteria |
1. Women with histologically/cytologically confirmed early adenocarcinoma of the breast, completely excised by surgery with curative intent (Ro) including:
a. Any node-positive cancer b. Any cancer greater than or equal to 3 cm c. Node negative cancer, grade II or III and 1 cm or greater 2. ER and/or PgR status positive 3. Postmenopausal 4. Patients on Hormone Replacement Therapy (HRT) which was discontinued at least four weeks prior to randomisation 5. Adequate haematological, renal and hepatic function 6. Accessible for follow-up for the duration of the trial 7. Eastern Cooperative Oncology Group (ECOG) performance status zero, one or two 8. Written informed consent (according to International Conference on Harmonisation [ICH]/Good Clinical Practice [GCP] and local Institutional Review Board [IRB] guidelines) 9. Randomisation within ten weeks of completing surgery +/- adjuvant chemotherapy |
| Participants - exclusion criteria |
1. Positive supraclavicular nodes
2. Evidence of distant metastases (M1) 3. Patients whose chemotherapy was started more than ten weeks after completion of primary surgery 4. Patients who have received previous hormonal treatment as adjuvant treatment for breast cancer 5. Patients who have received neoadjuvant chemotherapy 6. Neoadjuvant hormone therapy more than four weeks duration prior to surgery 7. Severe osteoporosis (bisphosphonates for therapeutic use is not an exclusion criterion) 8. Uncontrolled cardiac disease including unstable angina, Congestive Heart Failure (CHF) or arrhythmia requiring medical therapy or with a history of myocardial infarction within the past 3 months or any other serious concomitant disease 9. Psychiatric disorders preventing proper informed consent 10. Concomitant malignancies except for adequately treated carcinoma in situ of the uterine cervix or basal cell carcinoma of the skin 11. Patients with other malignancies must be disease free for at least five years 12. Concurrent participation in another clinical study (with the exception of adjuvant cytotoxic chemotherapy trials) involving investigational agents that may interfere with the results of the trial 13. Other serious illnesses that may interfere with subject compliance, adequate informed consent or determination of causality of adverse events 14. Patients on HRT, which was not discontinued at least four weeks prior to randomisation 15. Node-negative, grade I cancer less than 3 cm |
| Anticipated start date | 01/12/2001 |
| Anticipated end date | 31/10/2005 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 1275 in UK/ROI |
| Interventions |
Randomised to receive:
1. Tamoxifen 20 mg/day for 2.5-3 years then Exemestane 25 mg/day to complete five years 2. Exemestane 25 mg/day for five years |
| Primary outcome measure(s) | Relapse Free Survival (RFS) |
| Secondary outcome measure(s) |
1. Overall Survival (OS)
2. Incidence of contralateral breast cancer 3. Safety and long-term tolerability of both hormonal regimens |
| Sources of funding | Educational grant from Pfizer |
| Trial website | |
| Publications | |
| Contact name | Dr Margaret Grant |
| Address |
Cancer Research UK Clinical Trials Unit
University of Birmingham |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| Tel | +44 (0)121 414 3797 |
| Fax | +44 (0)121 414 3700 |
| m.r.grant@bham.ac.uk | |
| Sponsor | The University of Birmingham (UK) |
| Address | Edgbaston |
| City/town | Birmingham |
| Zip/Postcode | B15 2TT |
| Country | United Kingdom |
| Date applied | 01/07/2001 |
| Last edited | 06/08/2008 |
| Date ISRCTN assigned | 01/07/2001 |
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