Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer

Conditions

Breast Neoplasms

Brief summary

To compare recurrence free survival between two treatment groups (5 years with exemestane vs 2.5 to 3 years tamoxifen followed by 2 to 2.5 years of exemestane for a total duration of 5 years) This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted. Link to TEAM Trial \[971-ONC-0028-081/A5991026\] Study Results: http://clinicaltrials.gov/ct2/show/results/NCT00036270?term=971-ONC-0028-081&rank=1

Lisa Pilgram, Kai Yang, Ana-Alicia Beltran-Bless, Gregory R. Pond, Lisa Vandermeer et al. (25 authors)

Journal of Medical Internet Research2026-04-14

10.2196/88665

Validation of minimal risk of recurrence classification by the Breast Cancer Index in early stage breast cancer.

Jilderda MF, Bartlett JMS, Liefers GJ, Zhang Y, Dunn-Davies H, Rebattu V, Salunga R, Meershoek-Klein Kranenbarg E, de Munck L, Hasenburg A, Markopoulos C, Dirix L, van de Velde CJH, Rea D, Anderson AKL, Bastiaannet E, Treuner K, Taylor KJ.

2025-12-30

10.1038/s41523-025-00885-x

Does RSClin provide additional information over classic clinico-pathologic scores (PREDICT 2.1, INFLUENCE 2.0, CTS5)?

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.

2025-07-04

10.1016/j.breast.2025.104528

Identification of Distinct Prognostic Groups: Implications for Patient Selection to Targeted Therapies Among Anti-Endocrine Therapy–Resistant Early Breast Cancers

Jane Bayani, Elizabeth Kornaga, Cheryl Crozier, Gun Ho Jang, Lauren Bathurst et al. (15 authors)

JCO Precision Oncology2019-05-101 citations

10.1200/po.18.00373

Impact of age on breast cancer mortality and competing causes of death at 10 years follow-up in the adjuvant TEAM trial.

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.

2018-06-0635 citations

10.1016/j.ejca.2018.04.009

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.

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.

2017-07-1843 citations

10.1016/s1470-2045(17)30419-9

Adjuvant tamoxifen and exemestane in early breast cancer (TEAM): a randomised phase 3 trial.

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.

2011-01-01258 citations

10.1016/s0140-6736(10)62312-4

Interventions

DRUGexemestane

On tablet of 25 mg per day during 5 years

DRUGtamoxifen

Two tablets of tamoxifen 10 mg per day during 2.5 to 3 years followed by one tablet of exemestane 25 mg per day during 2 to 2.5 years for a total duration of 5 years of treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

50 Years to No maximum

Healthy volunteers

No

Inclusion criteria

* HR+ post-menopausal patients with non-metastatic breast cancer

Exclusion criteria

* Any of the following: HR-, non-menopausal patient, metastatic breast cancer

Design outcomes

Primary

Measure	Time frame
To compare recurrence free survival between two treatment groups.	2.75 years and 5 years

Secondary

Measure	Time frame
The quality of life of patients treated with exemestane to that of patients treated with tamoxifen	Every 3 months during first year then every 6 months for 4 years
Overall survival between the 2 treatment groups	Every 3 months during first year then every 6 months for 4 years
Incidence of a second breast cancer (contralateral) between the 2 treatment groups	Every 3 months during first year then every 6 months for 4 years
General tolerance in the short- and long-term between the 2 treatment groups	Every 3 months during first year then every 6 months dor 4 years

Countries

France

Outcome results

None listed