Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
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: July 14, 2016
Last verified: July 2016
  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:
  • Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant. [ Time Frame: Every 2 cycles up to 2 years ] [ Designated as safety issue: No ]
    TTP is defined as the time from first treatment to objective evidence of progression on the basis of radiological evaluation and/or physical exam (if physical examination identifies a site of measurable disease). Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions


Secondary Outcome Measures:
  • Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease) [ Time Frame: Every 2 cycles, up to 1 year ] [ Designated as safety issue: No ]

    Response and progression was evaluated after every 2 cycles by physical examination and imaging studies using the international RECIST criteria.

    Complete Response (CR), Partial Response (PR), Overall Response Rate (ORR), Stable Disease (SD), Progressive Disease (PD). Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI and/or CT: Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for a Partial Response nor sufficient increase to qualify for Progressive Disease (PD); PD, 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions; Complete Response (CR), Disappearance of all target lesions; Overall Response Rate (ORR), CR+PR


  • Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant [ Time Frame: Day 7 and Day 120 ] [ Designated as safety issue: No ]
    5 mL of venous whole blood was obtained before dosing and then at 1, 2, 4, 6, 8, and 24 hours after exemestane ingestion on each of the 2 time points.

  • 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
Study Completion Date: February 2014
Primary Completion Date: June 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   (Adult, Senior)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  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:
Publications:
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
Results First Received: November 10, 2015
Last Updated: July 14, 2016
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
Hormones
Estradiol
Fulvestrant
Exemestane
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Receptor Antagonists
Estrogen Antagonists
Hormone Antagonists
Estrogens
Aromatase Inhibitors
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 27, 2016