The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer (EFECT)
This study has been completed.
Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00065325
First received: July 21, 2003
Last updated: February 23, 2015
Last verified: February 2015
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Purpose
The purpose of this study is to compare the efficacy of Faslodex (fulvestrant) to Aromasin (exemestane) in hormone receptor positive postmenopausal women with advanced breast cancer. Patients will be treated until disease progression or until the investigator has determined that treatment is not in the best interest of the patient, whichever occurs first.
| Condition | Intervention | Phase |
|---|---|---|
|
Locally Advanced Breast Cancer Metastatic Breast Cancer |
Drug: Fulvestrant Drug: Exemestane |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double Blind, Multicenter Study to Compare the Efficacy and Tolerability of Fulvestrant (FASLODEX™) vs. Exemestane (AROMASIN™) in Postmenopausal Women With Hormone Receptor Positive Advanced Breast Cancer With Disease Progression After Prior Non-Steroidal Aromatase Inhibitor (AI) Therapy |
Resource links provided by NLM:
Further study details as provided by AstraZeneca:
Primary Outcome Measures:
- Time to disease progression (TTP) [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Objective response rate [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: No ]
- Overall survival [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: Yes ]
- Duration of response [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: No ]
- Clinical Benefit [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: No ]
- Quality of Life [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: No ]
- PK [ Time Frame: each visit ] [ Designated as safety issue: No ]
- Safety and tolerability. [ Time Frame: after 580 Progression events accrued ] [ Designated as safety issue: Yes ]
| Enrollment: | 694 |
| Study Start Date: | August 2003 |
| Study Completion Date: | September 2014 |
| Primary Completion Date: | June 2006 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: 1
Exemestane
|
Drug: Exemestane
oral capsule
Other Name: AROMASIN™
|
|
Experimental: 2
Fulvestrant
|
Drug: Fulvestrant
intramuscular injection
Other Names:
|
Eligibility| Ages Eligible for Study: | 32 Years to 91 Years (Adult, Senior) |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Biopsy confirmation of Breast Cancer
- Breast Cancer has continued to grow after having received treatment with an aromatase inhibitor
- Postmenopausal women defined as a women who has stopped having menstrual periods
- Evidence of hormone sensitivity
- Written informed consent to participate in the trial
Exclusion Criteria:
- Previous treatment with Faslodex (fulvestrant) or Aromasin (exemestane)
- Any hormonal therapy used to modify the course of an additional medical condition after prior treatment with a non-steroidal aromatase inhibitor
- Treatment with an investigational or non-approved drug within one month
- An existing serious disease, illness, or condition that will prevent participation or compliance with study procedures
- A history of allergies to any active or inactive ingredients of Faslodex or Exemestane (i.e. castor oil or Mannitol)
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: NCT00065325
Show 117 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00065325
Show 117 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Faslodex Medical Science Director, MD | AstraZeneca |
More Information
Additional Information:
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00065325 History of Changes |
| Other Study ID Numbers: | 9238IL/0048 EFECT D6997C00048 |
| Study First Received: | July 21, 2003 |
| Last Updated: | February 23, 2015 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by AstraZeneca:
|
Locally advanced breast cancer metastatic breast cancer Breast Cancer Cancer of Breast Cancer of the Breast |
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 23, 2016