Overview

This trial is active, not recruiting.

Condition breast cancer
Treatments exemestane, fulvestrant
Phase phase 2
Sponsor Ewa Mrozek
Collaborator Pfizer
Start date September 2005
End date December 2012
Trial size 40 participants
Trial identifier NCT00201864, NCI-2011-03154, OSU-0494

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection
exemestane Aromasin
25 mg orally per day
fulvestrant Faslodex
250 mg IM starting on Day 8 and then every 28 days.

Primary Outcomes

Measure
To evaluate the time to progression in women with hormone responsive advanced breast cancer treated with combination of exemestane and fulvestrant.
time frame: Every 2 cycles

Secondary Outcomes

Measure
overall clinical benefit (complete response rate, partial response and stable disease)
time frame: Day 1 of each cycle
side effects
time frame: Day 1 of each cycle
To determine the influence of fulvestrant on exemestane pharmacokinetics in a subset of 12 patients
time frame: Day 7 and 8; Day 120
To examine the effect of exemestane + fulvestrant on serum IGF-1 and IGFPB-3 levels
time frame: Prestudy, Day 7 and Day 120

Eligibility Criteria

Female participants at least 18 years old.

Inclusion Criteria: Must ER &/or PR+; - Postmenopausal; - No chemotherapy for metastatic - No prior Exemestane or Fulvestrant

Additional Information

Official title Phase II Trial of Exemestane (Aromasin) in Combination With Fulvestrant (Faslodex) in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
Principal investigator Ewa Mrozek, MD
Trial information was received from ClinicalTrials.gov and was last updated in October 2012.
Information provided to ClinicalTrials.gov by Ohio State University Comprehensive Cancer Center.