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

Condition(s) targeted: Breast Neoplasms

Intervention: exemestane (Drug)

Phase: Phase 2

Status: Terminated

Sponsored by: Pfizer

Official(s) and/or principal investigator(s):
Pfizer CT.gov Call Center, Study Director, Affiliation: Pfizer

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.

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.

Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Primary outcome: 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 outcome:

to characterize the pharmacodynamic profile of the two formulations in terms of estrogens, androgens, and sec hormone binding globulin

to characterize the pharmacokinetics of exemestane and 17 hydroexemestane after administration of the two formulations

to evaluate the relationships between pharmakokinetics and pharmacodynamics after intramuscular and oral administration of exemestane

to evaluate the effcacy (as tumor response)

to evaluate the incidence and severity of systemic toxicities and of the local tolerability of the injectable formulation

to evaluate the effect on serum bone turnover markers

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Female.

Criteria:

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

Pfizer Investigational Site, Leicester, United Kingdom

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Starting date: June 2002
Last updated: November 10, 2006