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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


Phase 3
50 Years
N/A
Not Enrolling
Female
Breast Neoplasms

Thank you

Trial Information

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


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years

Outcome Description:

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.

Outcome Time Frame:

Baseline (Month 0) up to 2.75 years

Safety Issue:

No

Principal Investigator

Pfizer CT.gov Call Center

Investigator Role:

Study Director

Investigator Affiliation:

Pfizer

Authority:

United States: Food and Drug Administration

Study ID:

971-ONC-0028-081

NCT ID:

NCT00036270

Start Date:

August 2001

Completion Date:

February 2011

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational SiteBirmingham, Alabama  35205
Pfizer Investigational SiteRochester, Minnesota  55905
Pfizer Investigational SiteCincinnait, Ohio  45236
Pfizer Investigational SiteSpringfield, Illinois  62701-1014
Pfizer Investigational SiteBronx, New York  10461
Pfizer Investigational SiteHouston, Texas  77030
Pfizer Investigational SiteRichmond, Virginia  23249
Pfizer Investigational SiteFederal Way, Washington  98003
Pfizer Investigational SiteFlagstaff, Arizona  86001
Pfizer Investigational SiteNorth Little Rock, Arkansas  72117
Pfizer Investigational SiteAurora, Colorado  80012
Pfizer Investigational SiteClearwater, Florida  33761
Pfizer Investigational SiteCarmel, Indiana  46032
Pfizer Investigational SiteCedar Rapids, Iowa  52403
Pfizer Investigational SiteKansas City, Kansas  66112
Pfizer Investigational SiteWestminster, Maryland  21157
Pfizer Investigational SiteNorth Adams, Massachusetts  01247
Pfizer Investigational SiteColumbia, Missouri  65201
Pfizer Investigational SiteLas Vegas, Nevada  89128
Pfizer Investigational SiteSanta Fe, New Mexico  87505
Pfizer Investigational SiteAsheville, North Carolina  28801
Pfizer Investigational SiteBartlesville, Oklahoma  74006
Pfizer Investigational SiteEugene, Oregon  97401
Pfizer Investigational SiteKingston, Pennsylvania  18704-5535
Pfizer Investigational SiteEasley,, South Carolina  29640