Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

The Ohio State University

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Fulvestrant

Drug: Exemestane

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00201864

OSU-0494

NCI-2011-03154 (Registry Identifier)

Details and patient eligibility

About

The purpose of this trial is to evaluate time to progression in women with hormone responsive advanced breast cancer treated with a combination of exemestane and fulvestrant.

Enrollment

40 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

Proven breast cancer
Metastatic or locally advanced breast cancer
Hormonally responsive disease defined as estrogen (ER) and/ or progesterone receptor (PR) positive (>10% staining by immunohistochemistry)
Postmenopausal status
No more than 1 prior chemotherapy for stage IV metastatic breast cancer allowed
ECOG (Eastern Cooperative Oncology Group) performance status 0-2
Adequate organ function
Exclusion Criteria:
No prior Exemestane or Fulvestrant
Uncontrolled intercurrent illness including but not limited to:
- ongoing or active infection
- symptomatic congestive heart failure
- unstable angina pectoris
- cardiac arrhythmia
- myocardial infarction within the last 3 months
- psychiatric illness/social situations that would limit compliance with study
Lymphangitic pulmonary disease; carcinomatous meningitis, bone marrow only metastases; and a rising tumor marker without any other site of metastatic disease.
Presence of bleeding diathesis or coagulopathy, patients requiring coumadin