Breast Neoplasms
Conditions
Brief 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.
Interventions
DRUGexemestane
Sponsors
Pfizer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 characterize the pharmacodynamic profile of the two formulations in terms of estrogens, androgens, and sec hormone binding globulin | — |
| 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 | — |
| to evaluate the efficacy (as tumor response) | — |
Countries
United Kingdom
Outcome results
None listed