Clinical trial · Interventional
Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women
Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women With Advanced Breast Cancer Having Progressed on Tamoxifen.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Neoplasms | Breast Neoplasm | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| exemestane | Drug | Exemestane | ALIAS |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- 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 outcomes (6)
- measure
- to characterize the pharmacodynamic profile of the two formulations in terms of estrogens, androgens, and sec hormone binding globulin
- measure
- to characterize the pharmacokinetics of exemestane and 17 hydroexemestane after administration of the two formulations
- measure
- to evaluate the relationships between pharmacokinetics and pharmacodynamics after intramuscular and oral administration of exemestane
- measure
- to evaluate the efficacy (as tumor response)
- measure
- to evaluate the incidence and severity of systemic toxicities and of the local tolerability of the injectable formulation
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available