Locally Advanced Breast CancerPhase 3EFECTNCT00065325

The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer

A Phase 3 study testing Fulvestrant and Exemestane in people with Locally Advanced Breast Cancer and Metastatic Breast Cancer, run by AstraZeneca at 117 sites in 15 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 32 to 91 years, women only
Conditions the study is for: Locally Advanced Breast Cancer, Metastatic Breast Cancer
What is being tested?: Fulvestrant and Exemestane
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 694 participants
Where: 117 sitesin 15 countries
Study dates: Aug 2003to Sep 2014
Phase: Phase 3
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 32 to 91 years
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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)

Trial locations and contacts

117 sites in 15 countries.

Country

City, postcode or hospital

117 sites in 15 countries

United States51 sites

Research Site
Albuquerque, New Mexico
Research Site
Arcadia, California
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Athens, Georgia
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Austin, Texas
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Baltimore, Maryland
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Bangor, Maine
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Baton Rouge, Louisiana
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Birmingham, Alabama
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Boca Raton, Florida
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Burlington, Vermont
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Canton, Ohio
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Charlotte, North Carolina
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Chicago, Illinois
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Columbia, South Carolina
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Dallas, Texas
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Durham, North Carolina
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Fountain Valley, California
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Frederick, Maryland
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Gainesville, Florida
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Greenville, South Carolina
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Harvey, Illinois
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Hershey, Pennsylvania
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Hooksett, New Hampshire
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Houston, Texas
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Iowa City, Iowa
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Jacksonville, Florida
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Kalamazoo, Michigan
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Lancaster, Pennsylvania
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Langhorne, Pennsylvania
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Laverne, California
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Livingston, New Jersey
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Long Beach, California
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Metairie, Louisiana
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Miami, Florida
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New Orleans, Louisiana
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New Port Richey, Florida
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Overland Park, Kansas
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Pensacola, Florida
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Pittsburgh, Pennsylvania
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Providence, Rhode Island
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Richmond, Virginia
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Royal Oak, Michigan
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Saint Joseph, Michigan
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San Antonio, Texas
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Santa Rosa, California
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Shreveport, Louisiana
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Spartenburg, South Carolina
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Springfield, Illinois
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Torrington, Connecticut
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Voorhees Township, New Jersey
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Washington D.C., District of Columbia

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Canada15 sites

Research Site
Edmonton, Alberta
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Kingston, Ontario
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London, Ontario
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Montreal, Quebec
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Newmarket, Ontario
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Oshawa, Ontario
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Ottawa, Ontario
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Penticton, British Columbia
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Québec, Quebec
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Sault Ste. Marie, Ontario
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St. John's, Newfoundland and Labrador
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Toronto, Ontario
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Vancouver, British Columbia
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Windsor, Ontario
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Winnipeg, Manitoba

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Denmark6 sites

Research Site
Aalborg
Research Site
Herning
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Hillerød
Research Site
København Ø
Research Site
Roskilde
Research Site
Sønderborg

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South Africa6 sites

Research Site
Bloemfontein, South Africa
Research Site
Cape Town, South Africa
Research Site
Johannesburg, South Africa
Research Site
Klerksdorp, North West
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Port Elizabeth, South Africa
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Pretoria, South Africa

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Spain6 sites

Research Site
Barcelona, Catalonia
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Hospitalet Dellobregat(barcelo, Catalonia
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Madrid, Madrid
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Seville, Andalusia
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Terrassa(barcelona), Catalonia
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Valencia, Valencia

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Argentina4 sites

Research Site
Buenos Aires, Buenos Aires
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Ciudad de Buenos Aires, Buenos Aires
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Mar del Plata, Buenos Aires
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Rosario, Santa Fe Province

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Belgium4 sites

Research Site
Brussels, Belgium
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Leuven, Belgium
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Ottignies, Belgium
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Wilrijk, Belgium

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Brazil4 sites

Research Site
Goiânia, Goiás
Research Site
Porto Alegre, Rio Grande do Sul
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Rio de Janeiro, Rio de Janeiro
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São Paulo, São Paulo

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France4 sites

Research Site
Bordeaux
Research Site
Lille
Research Site
Montpellier
Research Site
Vandœuvre-lès-Nancy

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Germany4 sites

Research Site
Augsburg
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Berlin
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Hamburg
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Regensburg

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Sweden4 sites

Research Site
Halmstad
Research Site
Lund
Research Site
Stockholm
Research Site
Uppsala

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Hungary3 sites

Research Site
Budapest
Research Site
Debrecen
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Szeged

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Russia3 sites

Research Site
Moscow
Research Site
Obninsk, Kaluga Oblast
Research Site
Saint Petersburg

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Israel2 sites

Research Site
Haifa
Research Site
Tel Aviv

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United Kingdom1 site

Research Site
Nottingham

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About this study

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

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.

Conditions: Locally Advanced Breast Cancer, Metastatic Breast Cancer
Being tested: Fulvestrant, Exemestane
Keywords: Locally advanced breast cancer, metastatic breast cancer, Breast Cancer, Cancer of Breast, Cancer of the Breast
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

FulvestrantDrug
Also called Faslodex, ZD9238
intramuscular injection
ExemestaneDrug
Also called AROMASIN™
oral capsule

Study groups in NCT00065325
Study group	Role	What they receive
1	Active comparator	Exemestane Receives: Drug: Exemestane
2	Experimental	Fulvestrant Receives: Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

Time to disease progression (TTP)
Measured: after 580 Progression events accrued

Secondary outcomes (7)

Objective response rate
Measured: after 580 Progression events accrued
Overall survival
Measured: after 580 Progression events accrued
Duration of response
Measured: after 580 Progression events accrued
Clinical Benefit
Measured: after 580 Progression events accrued
Quality of Life
Measured: after 580 Progression events accrued
PK
Measured: each visit
Safety and tolerability.
Measured: after 580 Progression events accrued

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Aug 2003Sep 2014

First posted23 Jul 2003 (estimated)
Study startAug 2003
Primary completionJun 2006
Study completionSep 2014

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Locally Advanced Breast CancerStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 694 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00065325
Sponsor's protocol ID: 9238IL/0048
Other IDs: EFECT, D6997C00048
Acronym: EFECT
Status last verified: Feb 2015
First submitted: 21 Jul 2003
Last updated: 24 Feb 2015
Results posted: No

Publications

Arizmendi C, Zhu Y, Khan M, Gable J, Reeve BB, King-Kallimanis B, Bell J. The FACT-GP5 as a global tolerability measure: responsiveness and robustness to missing assessments. Qual Life Res. 2024 Oct;33(10):2869-2880. doi: 10.1007/s11136-024-03740-x. Epub 2024 Jul 24.
PubMed 39046616

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 1
HER2 Vaccine for Locally Advanced Breast Cancer
Breast Cancer, HER2-positive Breast Cancer
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
Locally Advanced Breast Cancer, Metastatic Breast Cancer

All Locally Advanced Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT00065325
Acronym / sponsor ID: EFECT / 9238IL/0048
Conditions: Locally Advanced Breast Cancer, Metastatic Breast Cancer
Keywords: Locally advanced breast cancer, metastatic breast cancer, Breast Cancer, Cancer of Breast, Cancer of the Breast
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 694 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Aug 2003
Primary completion: Jun 2006 (actual)
Study completion: Sep 2014 (actual)
First posted: 23 Jul 2003 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
1	Active comparator	Drug: ExemestaneExemestane
2	Experimental	Drug: FulvestrantFulvestrant

Who may qualify

Ages: 32 to 91 years
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (5 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
FulvestrantAlso: Faslodex, ZD9238intramuscular injection	Drug	2
ExemestaneAlso: AROMASIN™oral capsule	Drug	1

Primary outcome

Time to disease progression (TTP)
Time frame: after 580 Progression events accrued

7 secondary outcomes

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

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2015.
Derived from this study: PubMed 39046616Arizmendi C, Zhu Y, Khan M, Gable J, Reeve BB, King-Kallimanis B, Bell J. The FACT-GP5 as a global tolerability measure: responsiveness and robustness to missing assessments. Qual Life Res. 2024 Oct;33(10):2869-2880. doi: 10.1007/s11136-024-03740-x. Epub 2024 Jul 24.
MEDLINEplus related topics: Breast CancerLink provided by the sponsor.
MEDLINEplus related topics: Cancer (General)Link provided by the sponsor.
MEDLINEplus related topics: Cancer--Living with CancerLink provided by the sponsor.
CSR-9238IL-0048.pdfLink provided by the sponsor.

Related trials for Locally Advanced Breast Cancer

RecruitingPhase 1/2
A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
RecruitingPhase 1/2
A Study of MR001 in Patients With Locally Recurrent or Metastatic Advanced Triple-Negative Breast Cancer (TNBC)
Triple-Negative Breast Cancer (TNBC)
RecruitingPhase 1
HER2 Vaccine for Locally Advanced Breast Cancer
Breast Cancer, HER2-positive Breast Cancer
Not yet recruitingPhase 1
A Study to Evaluate the Effects of GDC-4198 in Combination With Letrozole, Fulvestrant, or Giredestrant in Participants With Locally Advanced or Metastatic Hormone Receptor-Positive, HER2-Negatve Breast Cancer
Advanced or Metastatic Breast Cancer
RecruitingObservational study
A Study to Evaluate the Effectiveness and Safety of Inavolisib in Participants With Endocrine-resistant, PIK3CA-mutated, Hormone Receptor-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer
Locally Advanced Breast Cancer, Metastatic Breast Cancer

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

AstraZeneca Faslodex Medical Science Director, MD study director

AstraZeneca

117 sites in 15 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Fulvestrant and Exemestane in people with Locally Advanced Breast Cancer and Metastatic Breast Cancer, run by AstraZeneca at 117 sites in 15 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 117 sites in United States, Canada, Denmark, South Africa, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to disease progression (TTP) (time frame: after 580 Progression events accrued). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00065325, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2015.