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

NCT00201864

Last updated date
Study Location
Ohio State University
Columbus, Ohio, 43210, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Breast Cancer
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Advanced Information
Descriptive Information
Brief Title  ICMJE Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
Official Title  ICMJE Phase II Trial of Exemestane (Aromasin) in Combination With Fulvestrant (Faslodex) in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • 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
Study Arms  ICMJE Experimental: single-arm study
Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection
Interventions:
  • Drug: Exemestane
  • Drug: Fulvestrant
Publications * Mrózek E, Layman R, Ramaswamy B, Schaaf L, Li X, Ottman S, Shapiro CL. Phase II trial of exemestane in combination with fulvestrant in postmenopausal women with advanced, hormone-responsive breast cancer. Clin Breast Cancer. 2012 Apr;12(2):151-6. doi: 10.1016/j.clbc.2012.01.003.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 13, 2005)
40
Original Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2014
Actual Primary Completion Date June 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00201864
Other Study ID Numbers  ICMJE OSU-0494
NCI-2011-03154 ( Registry Identifier: Clinical Trial Reporting Program (CTRP) )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Ohio State University Comprehensive Cancer Center
Study Sponsor  ICMJE Ohio State University Comprehensive Cancer Center
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Ewa Mrozek, MDOhio State University
PRS Account Ohio State University Comprehensive Cancer Center
Verification Date June 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP