The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer (EFECT)
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| ClinicalTrials.gov Identifier: NCT00065325 |
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Recruitment Status :
Completed
First Posted : July 23, 2003
Last Update Posted : February 24, 2015
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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Brief Summary:
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 or disease | Intervention/treatment | Phase |
|---|---|---|
| Locally Advanced Breast Cancer Metastatic Breast Cancer | Drug: Fulvestrant Drug: Exemestane | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 694 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, 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 |
| Study Start Date : | August 2003 |
| Actual Primary Completion Date : | June 2006 |
| Actual Study Completion Date : | September 2014 |
Resource links provided by the National Library of Medicine
Genetics Home Reference related topics:
Breast cancer
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: 1
Exemestane
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Drug: Exemestane
oral capsule
Other Name: AROMASIN™ |
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Experimental: 2
Fulvestrant
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Drug: Fulvestrant
intramuscular injection
Other Names:
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Primary Outcome Measures :
- Time to disease progression (TTP) [ Time Frame: after 580 Progression events accrued ]
Secondary Outcome Measures :
- Objective response rate [ Time Frame: after 580 Progression events accrued ]
- Overall survival [ Time Frame: after 580 Progression events accrued ]
- Duration of response [ Time Frame: after 580 Progression events accrued ]
- Clinical Benefit [ Time Frame: after 580 Progression events accrued ]
- Quality of Life [ Time Frame: after 580 Progression events accrued ]
- PK [ Time Frame: each visit ]
- Safety and tolerability. [ Time Frame: after 580 Progression events accrued ]
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| Ages Eligible for Study: | 32 Years to 91 Years (Adult, Older Adult) |
| Sexes 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)
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00065325
Show 117 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | AstraZeneca Faslodex Medical Science Director, MD | AstraZeneca |
Additional Information:
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00065325 History of Changes |
| Other Study ID Numbers: |
9238IL/0048 EFECT D6997C00048 |
| First Posted: | July 23, 2003 Key Record Dates |
| Last Update Posted: | February 24, 2015 |
| Last Verified: | February 2015 |
Keywords provided by AstraZeneca:
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Locally advanced breast cancer metastatic breast cancer Breast Cancer Cancer of Breast Cancer of the Breast |
Additional relevant MeSH terms:
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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 |