NCT00032136

Brief Summary

RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using exemestane may fight breast cancer by reducing the production of estrogen. It is not yet known if exemestane is more effective than tamoxifen in preventing the recurrence of breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of exemestane with that of tamoxifen in treating postmenopausal women who have undergone surgery to remove early-stage breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,400

participants targeted

Target at P75+ for phase_3 breast-cancer

Timeline
Completed

Started Dec 2001

Typical duration for phase_3 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2001

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 8, 2002

Completed
11 months until next milestone

First Posted

Study publicly available on registry

January 27, 2003

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2009

Completed
Last Updated

August 2, 2013

Status Verified

March 1, 2007

First QC Date

March 8, 2002

Last Update Submit

August 1, 2013

Conditions

Breast Cancer

Keywords

stage I breast cancerstage II breast cancer

Outcome Measures

Primary Outcomes (1)

  • Relapse-free survival

Secondary Outcomes (4)

  • Overall survival

  • Incidence of second breast cancer in contralateral breast

  • Safety and long term tolerability

  • Quality of life

Interventions

exemestaneDRUG
tamoxifen citrateDRUG
adjuvant therapyPROCEDURE

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically or cytologically confirmed early adenocarcinoma of the breast * Completely excised by surgery with curative intent (R0) * Any N OR * Any primary tumor greater than 3 cm OR * Any primary tumor grade III and greater than 1 cm * M0 * No positive supraclavicular nodes * Hormone receptor status: * Estrogen and/or progesterone receptor positive PATIENT CHARACTERISTICS: Age: * Any age * See Menopausal status Sex: * Female Menopausal status: * Postmenopausal * Any age with bilateral oophorectomy or amenorrhea for at least 5 years OR * Age 50 or over: * Natural amenorrhea for at least 1 year OR * Chemotherapy-induced amenorrhea for at least 2 years OR * Radiation-induced amenorrhea (at least 3 months since prior radiotherapy) OR * Under age 50: * If amenorrheic for less than 5 years (any cause) or prior hysterectomy without bilateral surgical oophorectomy, follicle-stimulating hormone must be assayed to confirm postmenopausal status Performance status: * ECOG 0-2 Life expectancy: * Not specified Hematopoietic: * Platelet count greater than 100,000/mm3 * WBC greater than 3,000/mm3 Hepatic: * SGOT or SGPT less than 2.5 times upper limit of normal (ULN) Renal: * Creatinine less than 1.5 times ULN Cardiovascular: * No uncontrolled cardiac disease * No unstable angina * No congestive heart failure or arrhythmia requiring medical therapy * No myocardial infarction within the past 3 months Other: * No severe osteoporosis * No other malignancies within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer * No other serious concurrent disease that would preclude study * No psychiatric disorders that would preclude study PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * No prior neoadjuvant chemotherapy * No more than 10 weeks since completion of prior adjuvant chemotherapy Endocrine therapy: * No prior adjuvant hormonal therapy for breast cancer * No prior neoadjuvant hormonal therapy (prior to surgery) for duration of more than 4 weeks * At least 4 weeks since prior hormone replacement therapy Radiotherapy: * Not specified Surgery: * See Disease Characteristics * No more than 10 weeks since completion of curative surgery Other: * No other concurrent investigational agents or participation in another clinical study (except adjuvant cytotoxic chemotherapy studies) * Concurrent bisphosphonates allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

City Hospital - Birmingham

Birmingham, England, B18 7QH, United Kingdom

Location

Related Publications (10)

  • Hadji P, Asmar L, van Nes JG, Menschik T, Hasenburg A, Kuck J, Nortier JW, van de Velde CJ, Jones SE, Ziller M. The effect of exemestane and tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multinational (TEAM) trial: a meta-analysis of the US, German, Netherlands, and Belgium sub-studies. J Cancer Res Clin Oncol. 2011 Jun;137(6):1015-25. doi: 10.1007/s00432-010-0964-y. Epub 2010 Dec 18.

    PMID: 21170551BACKGROUND

  • van de Velde CJ, Rea D, Seynaeve C, Putter H, Hasenburg A, Vannetzel JM, Paridaens R, Markopoulos C, Hozumi Y, Hille ET, Kieback DG, Asmar L, Smeets J, Nortier JW, Hadji P, Bartlett JM, Jones SE. Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial. Lancet. 2011 Jan 22;377(9762):321-31. doi: 10.1016/S0140-6736(10)62312-4.

    PMID: 21247627RESULT

  • Kieback DG, Harbeck N, Bauer W, Hadji P, Weyer G, Menschik T, Hasenburg A. Endometrial effects of exemestane compared to tamoxifen within the Tamoxifen Exemestane Adjuvant Multicenter (TEAM) trial: results of a prospective gynecological ultrasound substudy. Gynecol Oncol. 2010 Dec;119(3):500-5. doi: 10.1016/j.ygyno.2010.08.006. Epub 2010 Sep 15.

    PMID: 20832103RESULT

  • Hadji P, Ziller M, Kieback DG, Dornoff W, Tessen HW, Menschik T, Kuck J, Melchert F, Hasenburg A. Effects of exemestane and tamoxifen on bone health within the Tamoxifen Exemestane Adjuvant Multicentre (TEAM) trial: results of a German, 12-month, prospective, randomised substudy. Ann Oncol. 2009 Jul;20(7):1203-9. doi: 10.1093/annonc/mdn762. Epub 2009 Feb 13.

    PMID: 19218306RESULT

  • Hadji P, Ziller M, Kieback DG, Menschik T, Kalder M, Kuck J, Hasenburg A. The effect of exemestane or tamoxifen on markers of bone turnover: results of a German sub-study of the Tamoxifen Exemestane Adjuvant Multicentre (TEAM) trial. Breast. 2009 Jun;18(3):159-64. doi: 10.1016/j.breast.2009.03.003. Epub 2009 Apr 11.

    PMID: 19364653RESULT

  • Beltran-Bless AA, Pond GR, Bayani J, Barker SL, Spears M, Mallon E, Taylor KJ, Hasenburg A, Markopoulos C, Dirix L, Meershoek-Klein Kranenbarg E, van de Velde CJH, Rea DW, Vandermeer L, Hilton J, Bartlett JMS, Clemons M. Does RSClin provide additional information over classic clinico-pathologic scores (PREDICT 2.1, INFLUENCE 2.0, CTS5)? Breast. 2025 Oct;83:104528. doi: 10.1016/j.breast.2025.104528. Epub 2025 Jul 4.

    PMID: 40633461DERIVED

  • Bayani J, Kornaga EN, Crozier C, Jang GH, Bathurst L, Kalatskaya I, Trinh QM, Yao CQ, Livingstone J, Boutros PC, Spears M, McPherson JD, Stein LD, Rea D, Bartlett JMS. Identification of Distinct Prognostic Groups: Implications for Patient Selection to Targeted Therapies Among Anti-Endocrine Therapy-Resistant Early Breast Cancers. JCO Precis Oncol. 2019 Dec;3:1-13. doi: 10.1200/PO.18.00373.

    PMID: 35100692DERIVED

  • Derks MGM, Bastiaannet E, van de Water W, de Glas NA, Seynaeve C, Putter H, Nortier JWR, Rea D, Hasenburg A, Markopoulos C, Dirix LY, Portielje JEA, van de Velde CJH, Liefers GJ. Impact of age on breast cancer mortality and competing causes of death at 10 years follow-up in the adjuvant TEAM trial. Eur J Cancer. 2018 Aug;99:1-8. doi: 10.1016/j.ejca.2018.04.009. Epub 2018 Jun 6.

    PMID: 29885375DERIVED

  • Derks MGM, Blok EJ, Seynaeve C, Nortier JWR, Kranenbarg EM, Liefers GJ, Putter H, Kroep JR, Rea D, Hasenburg A, Markopoulos C, Paridaens R, Smeets JBE, Dirix LY, van de Velde CJH. Adjuvant tamoxifen and exemestane in women with postmenopausal early breast cancer (TEAM): 10-year follow-up of a multicentre, open-label, randomised, phase 3 trial. Lancet Oncol. 2017 Sep;18(9):1211-1220. doi: 10.1016/S1470-2045(17)30419-9. Epub 2017 Jul 18.

    PMID: 28732650DERIVED

  • Bartlett JM, Brookes CL, Piper T, van de Velde CJ, Stocken D, Lyttle N, Hasenburg A, Quintayo MA, Kieback DG, Putter H, Markopoulos C, Kranenbarg EM, Mallon EA, Dirix LY, Seynaeve C, Rea DW. Do type 1 receptor tyrosine kinases inform treatment choice? A prospectively planned analysis of the TEAM trial. Br J Cancer. 2013 Oct 29;109(9):2453-61. doi: 10.1038/bjc.2013.609. Epub 2013 Oct 3.

    PMID: 24091623DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestaneTamoxifenChemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

StilbenesBenzylidene CompoundsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsCombined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Daniel Rea, MD

    City Hospital Birmingham

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 8, 2002

First Posted

January 27, 2003

Study Start

December 1, 2001

Study Completion

April 1, 2009

Last Updated

August 2, 2013

Record last verified: 2007-03

Locations

GB(1)