A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer

NCT00649090 | Completed Phase 4

• 1 other identifier: A5991077
• Study Type: interventional
• Target: 1,549
• Locations: 1 country
• Sites: 61

Brief Summary

The purpose of this study was to give access to postmenopausal women with estrogen sensitive primary breast cancer to exemestane for the adjuvant treatment of breast cancer after the use of tamoxifen and to collect all serious adverse events.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (1)

• Assess for serious adverse events

  Months 3, 6, 12, 18, 24, and 30; Follow-up visit 28 days posttreatment

Secondary Outcomes (1)

• Safety Surveillance Program

  Duration of trial

Study Arms (1)

Exemestane group

ACTIVE COMPARATOR

Drug: exemestane

Interventions

exemestane DRUG

Exemestane 25 mg oral tablet once daily for a maximum of 3 years

Exemestane group

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Postmenopausal patients
• Patients with early breast cancer after adequate loco-regional treatment and eventual adjuvant chemotherapy, treated with tamoxifen for 2-3 years OR treated with tamoxifen for 2-3 years and consecutive exemestane treatment, provided the total duration of endocrine treatment is less than 5 years
• Estrogen receptor positive breast cancer patients
• Patients who remain free from disease following treatment with tamoxifen

You may not qualify if:

• Patients taking other drugs for the adjuvant treatment of breast cancer
• Patients taking hormone replacement therapy
• Donation of blood or blood products for transfusion during the 30 days prior to initiation of treatment with study drug, at any time during the program or 30 days after completion of treatment

Sponsors & Collaborators

• Pfizer: lead

Study Sites (61)

Pfizer Investigational Site

Aalst, 9300, Belgium

Location

Pfizer Investigational Site

Antwerp, 2020, Belgium

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Pfizer Investigational Site

Arlon, 6700, Belgium

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Pfizer Investigational Site

Baudour, 7331, Belgium

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Bonheiden, 2820, Belgium

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Bouge, 5004, Belgium

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Boussu, 7300, Belgium

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Pfizer Investigational Site

Braine-l'Alleud, 1420, Belgium

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Pfizer Investigational Site

Brasschaat, 2930, Belgium

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Pfizer Investigational Site

Bruges, 8000, Belgium

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Pfizer Investigational Site

Brussels, 1000, Belgium

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Pfizer Investigational Site

Brussels, 1020, Belgium

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Pfizer Investigational Site

Brussels, 1040, Belgium

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Pfizer Investigational Site

Brussels, 1050, Belgium

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Brussels, 1070, Belgium

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Pfizer Investigational Site

Brussels, 1180, Belgium

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Pfizer Investigational Site

Brussels, 1200, Belgium

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Brussels, 1210, Belgium

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Brussels, B-1040, Belgium

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Charleroi, 6000, Belgium

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Chênée, 4032, Belgium

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Chimay, 6460, Belgium

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Dendermonde, 9200, Belgium

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Duffel, 2570, Belgium

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Edegem, 2650, Belgium

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Eupen, 4700, Belgium

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Genk, 3600, Belgium

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Pfizer Investigational Site

Ghent, 9000, Belgium

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Pfizer Investigational Site

Gilly (Charleroi), 6060, Belgium

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Pfizer Investigational Site

Gosselies, 6041, Belgium

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Pfizer Investigational Site

Halle, 1500, Belgium

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Pfizer Investigational Site

Hasselt, 3500, Belgium

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Herstal, 4040, Belgium

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Pfizer Investigational Site

Hornu, 7301, Belgium

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Huy, 4500, Belgium

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Kortrijk, 8500, Belgium

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La Louvière, 7100, Belgium

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Leuven, 3000, Belgium

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Libramont, 6800, Belgium

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Lier, 2500, Belgium

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Liège, 4000, Belgium

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Pfizer Investigational Site

Mechelen, 2800, Belgium

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Merksem, 2170, Belgium

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Pfizer Investigational Site

Mons, 7000, Belgium

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Montigny-le-Tilleul, 6110, Belgium

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Pfizer Investigational Site

Mouscron, 7700, Belgium

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Pfizer Investigational Site

Namur, 5000, Belgium

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Pfizer Investigational Site

Ottignies, 1340, Belgium

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Pfizer Investigational Site

Rocourt, 4000, Belgium

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Pfizer Investigational Site

Roeselare, 8800, Belgium

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Pfizer Investigational Site

Seraing, 4100, Belgium

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Pfizer Investigational Site

Sint-Niklaas, 9100, Belgium

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Pfizer Investigational Site

Soignies, 7060, Belgium

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Pfizer Investigational Site

Tongeren, 3700, Belgium

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Pfizer Investigational Site

Torhout, 8820, Belgium

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Pfizer Investigational Site

Tournai, 7500, Belgium

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Pfizer Investigational Site

Turnhout, 2300, Belgium

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Pfizer Investigational Site

Verviers, 4800, Belgium

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Pfizer Investigational Site

Waregem, 8790, Belgium

Location

Pfizer Investigational Site

Wilrijk, 2610, Belgium

Location

Pfizer Investigational Site

Yvoir, 5530, Belgium

Location

Related Links

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

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestane

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Pfizer CT.gov Call Center

  Pfizer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: March 27, 2008
• First Posted: April 1, 2008
• Study Start: March 1, 2005
• Primary Completion: April 1, 2007
• Study Completion: April 1, 2007
• Last Updated: September 29, 2008

Record last verified: 2008-09

Locations

BE (61)