Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane (TEAM)

• ClinicalTrials.gov Identifier: NCT00036270
• Recruitment Status: Completed
• First Posted: May 9, 2002
• Results First Posted: December 4, 2009
• Last Update Posted: October 28, 2015
• Sponsor: Pfizer
• Information provided by (Responsible Party): Pfizer

Tracking Information

• First Submitted Date: May 8, 2002
• First Posted Date: May 9, 2002
• Results First Submitted Date: October 30, 2009
• Results First Posted Date: December 4, 2009
• Last Update Posted Date: October 28, 2015
• Study Start Date: August 2001
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 27, 2012)

• Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years [ Time Frame: Baseline (Month 0) up to 2.75 years ]
  Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.
• Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years [ Time Frame: Baseline (Month 0) up to 5 years ]
  Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.

• Original Primary Outcome Measures: Not Provided

Current Secondary Outcome Measures (submitted: March 27, 2012)

• Number of Events for Overall Survival (OS) [ Time Frame: Baseline (Month 0) up to 5 years ]
  Number of events (death) to time of observation for OS. OS is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.
• Time to New Primary Breast Cancers [ Time Frame: Baseline (Month 0) up to 5 years ]
  New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC).
• Number of Events for Time to Relapse [ Time Frame: Baseline (Month 0) up to 5 years ]
  Number of events to time of observation for relapse. Relapse is defined as all recurrences of the primary tumor (loco-regional and distant recurrence), second primary breast cancer, contralateral breast cancer.
• Number of Participants With New Primary Non-breast Cancers [ Time Frame: Baseline (Month 0) up to 5 years ]
  Number of participants with new primary non-breast cancers which included colorectal cancer, lung cancer, endometrial cancer, ductal carcinoma in situ (DCIS) and other primary cancer types.

• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane
• Official Title: Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen For 2.5- 3 Years Followed By Exemestane (Aromasin) For A Total Of 5 Years As Adjuvant Therapy For Postmenopausal, Receptor Positive, Node Negative or Node Positive Breast Cancer Patients

Brief Summary

To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer.

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.

• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Neoplasms

Intervention

• Drug: exemestane (Aromasin)
  exemestane, orally, 25 mg, for 5 years
  Other Name: aromasin
• Drug: tamoxifen + exemestane
  tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy

Study Arms

• Experimental: exemestane
  Intervention: Drug: exemestane (Aromasin)
• Experimental: tamoxifen + exemestane
  Intervention: Drug: tamoxifen + exemestane

Publications *

• Noordhoek I, Blok EJ, Meershoek-Klein Kranenbarg E, Putter H, Duijm-de Carpentier M, Rutgers EJT, Seynaeve C, Bartlett JMS, Vannetzel JM, Rea DW, Hasenburg A, Paridaens R, Markopoulos CJ, Hozumi Y, Portielje JEA, Kroep JR, van de Velde CJH, Liefers GJ. Overestimation of Late Distant Recurrences in High-Risk Patients With ER-Positive Breast Cancer: Validity and Accuracy of the CTS5 Risk Score in the TEAM and IDEAL Trials. J Clin Oncol. 2020 Oct 1;38(28):3273-3281. doi: 10.1200/JCO.19.02427. Epub 2020 Jul 24.
• 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.
• 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.
• 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: June 29, 2011): 9779
• Original Enrollment: Not Provided
• Actual Study Completion Date: February 2011
• Actual Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• Histologically/cytologically confirmed adenocarcinoma of the breast, followed by adequate surgical resection and/or radiotherapy, and/or adjuvant chemotherapy, if indicated.
• Stage T1-3 N0-2 Mo, Any TNM stage BC for whom adjuvant hormonal therapy is being considered.

Exclusion Criteria:

• Those patients not deemed to have had potentially curative primary surgical treatment or one of the following criteria:
• Inflammatory breast cancer
• Histologically positive supraclavicular nodes
• Ulceration/infiltration of local skin metastasis
• Neoadjuvant chemotherapy
• Ductal carcinoma in situ (DCIS) or lobular carcinoma in situ (LCIS) without invasion
• ER and PR negative primary tumor or ER/PR unknown status.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00036270
• Other Study ID Numbers: 971-ONC-0028-081; A5991026
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Pfizer
• Study Sponsor: Pfizer
• Collaborators: Not Provided

Investigators

• Study Director: Pfizer CT.gov Call Center; Pfizer

• PRS Account: Pfizer
• Verification Date: October 2015