Exemestane in Combination With Fulvestrant in Postmenopausal Women With Hormone Sensitive Advanced Breast Cancer
This study is ongoing, but not recruiting participants.
Sponsor:
Ewa Mrozek
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
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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 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 May 19, 2013