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

Last updated on December 16, 2017

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Bessemer, Alabama, 35022 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Neoplasms
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
50+ years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- 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.

NCT00036270
Pfizer
Completed
Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane

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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Breast Neoplasms
  • 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
  • Experimental: exemestane
    Intervention: Drug: exemestane (Aromasin)
  • Experimental: tamoxifen + exemestane
    Intervention: Drug: tamoxifen + exemestane


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
9779
February 2011
October 2008   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: Female
50 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00036270
971-ONC-0028-081
A5991026
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
October 2015

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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1-800-718-1021

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[email protected]



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