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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Ewa Mrozek, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00201864
First received: September 12, 2005
Last updated: October 9, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Drug: Exemestane
Drug: Fulvestrant
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Trial of Exemestane (Aromasin) in Combination With Fulvestrant (Faslodex) in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer

Resource links provided by NLM:


Further study details as provided by Ohio State University Comprehensive Cancer Center:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • overall clinical benefit (complete response rate, partial response and stable disease) [ Time Frame: Day 1 of each cycle ] [ Designated as safety issue: No ]
  • side effects [ Time Frame: Day 1 of each cycle ] [ Designated as safety issue: Yes ]
  • To determine the influence of fulvestrant on exemestane pharmacokinetics in a subset of 12 patients [ Time Frame: Day 7 and 8; Day 120 ] [ Designated as safety issue: No ]
  • To examine the effect of exemestane + fulvestrant on serum IGF-1 and IGFPB-3 levels [ Time Frame: Prestudy, Day 7 and Day 120 ] [ Designated as safety issue: No ]

Enrollment: 40
Study Start Date: September 2005
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: single-arm study
Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection
Drug: Exemestane
25 mg orally per day
Other Name: Aromasin
Drug: Fulvestrant
250 mg IM starting on Day 8 and then every 28 days.
Other Name: Faslodex

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Must ER &/or PR+;

  • Postmenopausal;
  • No chemotherapy for metastatic
  • No prior Exemestane or Fulvestrant
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00201864

Locations
United States, Ohio
Ohio State University
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ewa Mrozek
Pfizer
Investigators
Principal Investigator: Ewa Mrozek, MD Ohio State University
  More Information

Additional Information:
No publications provided

Responsible Party: Ewa Mrozek, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT00201864     History of Changes
Other Study ID Numbers: OSU-0494, NCI-2011-03154
Study First Received: September 12, 2005
Last Updated: October 9, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Ohio State University Comprehensive Cancer Center:
Postmenopausal
Women

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Exemestane
Fulvestrant
Estradiol
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Aromatase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Estrogen Antagonists
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Estrogens
Hormones

ClinicalTrials.gov processed this record on August 20, 2014