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

Condition(s) targeted: Breast Neoplasms

Intervention: exemestane (Drug); tamoxifen (Drug)

Phase: Phase 3

Status: Active, not recruiting

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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)

Official title: Multicenter, Randomized, Open-Label Study To Compare The Efficacy, Tolerance And Quality Of Life Of 5 Years Of Adjuvant Exemestane (Aromasin) Therapy With 2.5 To 3 Years Of Adjuvant Tamoxifen Therapy, Followed By 2 To 2.5 Years Of Exemestane For A Total Duration Of 5 Years To Treat HR+ Post-Menopausal Patients With Non-Metastatic Breast Cancer

Study design: Treatment, Randomized, Open Label, Parallel Assignment, Safety/Efficacy Study

Primary outcome: To compare recurrence free survival between two treatment groups.

Secondary outcome:

Overall survival between the 2 treatment groups

incidence of a second breast cancer (contralateral) between the 2 treatment groups

General tolerance in the short- and long-term between the 2 treatment groups

The quality of life of patients treated with exemestane to that of patients treated with tamoxifen

Minimum age: 50 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

Inclusion Criteria:

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

Exclusion Criteria:

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

Pfizer Investigational Site, Neuilly 92200, France

Pfizer Investigational Site, Paris 75248, France

Pfizer Investigational Site, Mareuil les Meaux, France

Pfizer Investigational Site, Quincy sous Senart 91480, France

Pfizer Investigational Site, Ris Orangis 91130, France

Pfizer Investigational Site, St Cloud 92210, France

Pfizer Investigational Site, Saint Brieuc 22105, France

Pfizer Investigational Site, Vannes 56000, France

Pfizer Investigational Site, Nantes Cedex 2 44202, France

Pfizer Investigational Site, Saint-Herblain 44805, France

Pfizer Investigational Site, Evreux 27000, France

Pfizer Investigational Site, Rouen 76000, France

Pfizer Investigational Site, Blois 41000, France

Pfizer Investigational Site, Le Havre 76600, France

Pfizer Investigational Site, le Havre 76600, France

Pfizer Investigational Site, Brest 29283, France

Pfizer Investigational Site, Lorient, France

Pfizer Investigational Site, St Herblain 44805, France

Pfizer Investigational Site, Lille 59000, France

Pfizer Investigational Site, CROIX 59170, France

Pfizer Investigational Site, Nancy 54000, France

Pfizer Investigational Site, Amiens 80000, France

Pfizer Investigational Site, Chaumont 52000, France

Pfizer Investigational Site, Strasbourg, France

Pfizer Investigational Site, Dijon 21000, France

Pfizer Investigational Site, Chalon sur Saone 71100, France

Pfizer Investigational Site, Dunkerque 59140, France

Pfizer Investigational Site, Douai 59500, France

Pfizer Investigational Site, Vandoeuvre les Nancy 54511, France

Pfizer Investigational Site, Reims 51100, France

Pfizer Investigational Site, Metz 57072, France

Pfizer Investigational Site, Montbeliard 25200, France

Pfizer Investigational Site, NICE Cedex 1 06050, France

Pfizer Investigational Site, Avignon Cedex 2 84082, France

Pfizer Investigational Site, Nimes 30900, France

Pfizer Investigational Site, Hyres 83400, France

Pfizer Investigational Site, MOUGINS 06250, France

Pfizer Investigational Site, Cagne sur Mer 06805, France

Pfizer Investigational Site, Lyon 69008, France

Pfizer Investigational Site, Toulon 83056, France

Pfizer Investigational Site, Marseille 13012, France

Pfizer Investigational Site, Marseille 13006, France

Pfizer Investigational Site, Marseille 13009, France

Pfizer Investigational Site, Draguignan 83007, France

Pfizer Investigational Site, Aix en Provence 13616, France

Pfizer Investigational Site, Annecy Cedex 74011, France

Pfizer Investigational Site, Montpellier 34059, France

Pfizer Investigational Site, Montelimar 26026, France

Pfizer Investigational Site, Bordeaux CEDEX 33000, France

Pfizer Investigational Site, Toulouse 31000, France

Pfizer Investigational Site, Toulouse 31400, France

Pfizer Investigational Site, Bayonne 64100, France

Pfizer Investigational Site, Montauban 82017, France

Pfizer Investigational Site, L'Union 31240, France

Pfizer Investigational Site, Pessac 33600, France

Pfizer Investigational Site, Bordeaux 33076, France

Pfizer Investigational Site, Marseille, BE1 01971 13285, France

Pfizer Investigational Site, Compiegne, BE1 02256 60200, France

Pfizer Investigational Site, Rennes, BE1 03677 35033, France

Pfizer Investigational Site, Brest, BE1 04292 29609, France

To obtain contact information for a study center near you, click here.

Starting date: January 2002
Ending date: September 2011
Last updated: May 23, 2008