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

Pfizer

Status and phase: Terminated; Phase 2

Conditions: Breast Neoplasms

Treatments: Drug: exemestane

Study type: Interventional

Funder types: Industry

Identifiers

NCT00040014

971-ONC-0401-003

Details and patient eligibility

About

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.

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)