NCT00201864

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Sep 2005

Longer than P75 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2005

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
1.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2014

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

August 15, 2016

Completed
Last Updated

July 26, 2018

Status Verified

June 1, 2018

Enrollment Period

6.8 years

First QC Date

September 12, 2005

Results QC Date

November 10, 2015

Last Update Submit

June 28, 2018

Conditions

Breast Cancer

Keywords

PostmenopausalWomen

Outcome Measures

Primary Outcomes (1)

  • Time to Progression (TTP) in Women With Hormone Responsive Advanced Breast Cancer Treated With Combination of Exemestane and Fulvestrant.

    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

    Every 2 cycles up to 2 years

Secondary Outcomes (3)

  • Overall Clinical Benefit (Complete Response Rate, Partial Response and Stable Disease)

    Every 2 cycles, up to 1 year

  • Maximum Plasma Concentration (Cmax) of Exemestane When Administered Alone and With Fulvestrant

    Day 7 and Day 120

  • Examine the Effect of Exemestane + Fulvestrant on Serum IGF-1 and IGFPB-3 Levels

    Prestudy, Day 7 and Day 120

Study Arms (1)

single-arm study

EXPERIMENTAL

Combination of daily exemestane 25 mg with monthly 250 mg Fulvestrant injection

Drug: ExemestaneDrug: Fulvestrant

Interventions

ExemestaneDRUG

25 mg orally per day

Also known as: Aromasin
single-arm study
FulvestrantDRUG

250 mg IM starting on Day 8 and then every 28 days.

Also known as: Faslodex
single-arm study

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

  • Mrozek 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.

    PMID: 22444722RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

exemestaneFulvestrant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

Title
Ewa Mrozek
Organization
The Ohio State University
Ewa.Mrozek@osumc.edu
614-293-7956

Study Officials

  • Ewa Mrozek, MD

    Ohio State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 20, 2005

Study Start

September 1, 2005

Primary Completion

June 1, 2012

Study Completion

February 1, 2014

Last Updated

July 26, 2018

Results First Posted

August 15, 2016

Record last verified: 2018-06

Locations

US(1)