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

Information source: Pfizer
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

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.

Clinical Details

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

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 pharmacokinetics and pharmacodynamics after intramuscular and oral administration of exemestane

to evaluate the efficacy (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.


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

Locations and Contacts

Pfizer Investigational Site, Leicester, United Kingdom
Additional Information

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

Starting date: June 2002
Last updated: February 14, 2012

Page last updated: August 23, 2015

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