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Open-Label, Multicentre, Controlled Study Of Exemestane (Aromasin®) With Or Without Celecoxib (Celebrex®) In Postmenopausal Women With Advanced Breast Cancer (ABC) Having Progressed On Tamoxifen


Phase 2
18 Years
N/A
Not Enrolling
Female
Breast Neoplasms

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Trial Information

Open-Label, Multicentre, Controlled Study Of Exemestane (Aromasin®) With Or Without Celecoxib (Celebrex®) In Postmenopausal Women With Advanced Breast Cancer (ABC) Having Progressed On Tamoxifen


Inclusion Criteria:



- Postmenopausal female patient with histologically or cytologically confirmed breast
cancer having progressed on Tamoxifen.

- Advanced disease: patients with advanced breast carcinoma with disease progression
who had progressed/relapsed following > 8 weeks of treatment with Tamoxifen for
advanced disease; or progressed during adjuvant Tamoxifen for at least 6 or 12 months
depending on receptor status; or progressed within 12 months from completion of
adjuvant treatment with Tamoxifen.

- at least one measurable lesion

Exclusion Criteria:

- More than one previous chemotherapy and/or more than one hormonotherapy for advanced
disease.

- Previous hormonotherapy for advanced disease other than Tamoxifen.

- Myocardial infarction within previous 6 mo

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:

Number of Subjects With Clinical Benefit

Outcome Time Frame:

Baseline, Week 8, 16, 24, and every 12 weeks beyond 24 up to Week 108 and every 24 weeks thereafter until 9 months following last subject last visit (LSLV)

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:

NQ8-01-02-013

NCT ID:

NCT00038103

Start Date:

January 2002

Completion Date:

March 2008

Related Keywords:

  • Breast Neoplasms
  • Breast Neoplasms
  • Neoplasms

Name

Location

Pfizer Investigational SiteHouston, Texas  77030