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

• Status: Terminated
• Trial end date: 2006-12-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Pfizer
• Treatments: Exemestane

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