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 |
Recruitment Status :
Completed
First Posted : July 23, 2003
Last Update Posted : February 24, 2015
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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 |

Arm | Intervention/treatment |
---|---|
Active Comparator: 1
Exemestane
|
Drug: Exemestane
oral capsule
Other Name: AROMASIN™ |
Experimental: 2
Fulvestrant
|
Drug: Fulvestrant
intramuscular injection
Other Names:
|
- Time to disease progression (TTP) [ Time Frame: after 580 Progression events accrued ]
- 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 |
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)

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

Study Director: | AstraZeneca Faslodex Medical Science Director, MD | AstraZeneca |
Responsible Party: | AstraZeneca |
ClinicalTrials.gov Identifier: | NCT00065325 |
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 |
Locally advanced breast cancer metastatic breast cancer Breast Cancer Cancer of Breast Cancer of the Breast |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Fulvestrant Exemestane Antineoplastic Agents, Hormonal Antineoplastic Agents |
Estrogen Receptor Antagonists Estrogen Antagonists Hormone Antagonists Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs Aromatase Inhibitors Steroid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |