Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women

Breast Neoplasms Clinical Trial

Official title:

Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women With Advanced Breast Cancer Having Progressed on Tamoxifen.

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00040014
• Other study ID #: 971-ONC-0401-003
• Status: Terminated
• Phase: Phase 2
• First received: June 18, 2002
• Last updated: February 14, 2012
• Start date: June 2002
• Est. completion date: December 2006

Study information

• Verified date: February 2012
• Source: Pfizer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to find out if the two different formulations of exemestane (Aromasin), oral and injectable, are equivalent in terms of pharmacodynamics and pharmacokinetics, i.e., if ultimately both formulations have the same efficacy in postmenopausal women with metastatic breast cancer who have failed previous antiestrogens therapy and are equally safe.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 100
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• other diagnosed with breast cancer

• estrogen receptor positivity

• Postmenopausal status

• advanced disease

• progression to previous tamoxifen therapy

Exclusion Criteria:

• more than 1 chemotherapy and / or more than 1 hormonotherapy for advanced disease

• previous hormonotherapy other than Tamoxifen

Study Design

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

Related Conditions & MeSH terms

• Breast Neoplasms

Intervention

Drug:
• exemestane

Locations

Country	Name	City	State
United Kingdom	Pfizer Investigational Site	Leicester

Sponsors (1)

Lead Sponsor	Collaborator
Pfizer

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To determine the pharmacodynamic equivalence at steady state of the IM formulation of exemestane with the oral formulation in terms of plasma estrone sulphate inhibitory effect in postmenopausal women with advanced breast cancer.
Secondary	to characterize the pharmacodynamic profile of the two formulations in terms of estrogens, androgens, and sec hormone binding globulin
Secondary	to characterize the pharmacokinetics of exemestane and 17 hydroexemestane after administration of the two formulations
Secondary	to evaluate the relationships between pharmacokinetics and pharmacodynamics after intramuscular and oral administration of exemestane
Secondary	to evaluate the efficacy (as tumor response)
Secondary	to evaluate the incidence and severity of systemic toxicities and of the local tolerability of the injectable formulation
Secondary	to evaluate the effect on serum bone turnover markers

External Links

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