Aromasin Vs Arimidex Study As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer

A Phase 3 study testing exemestane and anastrozole in people with Breast Neoplasms, run by Pfizer at 47 sites in Japan.

Completed

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

Trial summary

To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer. Read more about this study

Who is it for?: Ages 20 years and older, women only
Conditions the study is for: Breast Neoplasms
What is being tested?: exemestane and anastrozole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 298 participants
Where: 47 sitesJapan
Study dates: Apr 2005to Dec 2010
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 20 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Have histologically or cytologically confirmed breast cancer at original diagnosis. At study entry, the patient must have metastatic progressive or locally recurrent inoperable breast cancer.

Who cannot join

Having received any hormonal therapy (e.g., Tamoxifen, LHRH-agonists) ovariectomy or any chemotherapy for advanced/recurrent breast cancer

Trial locations and contacts

47 sites in 1 country.

City, postcode or hospital

47 sites in 1 country

Japan47 sites

Pfizer Investigational Site
Akashi, Hyōgo
Pfizer Investigational Site
Amagasaki, Hyōgo
Pfizer Investigational Site
Anjo, Aichi-ken
Pfizer Investigational Site
Bunkyo-ku, Tokyo
Pfizer Investigational Site
Chiba, Chiba
Pfizer Investigational Site
Chiba
Pfizer Investigational Site
Chiyoda-ku, Tokyo
Pfizer Investigational Site
Chuo-Ku, Tokyo
Pfizer Investigational Site
Fukuoka, Fukuoka
Pfizer Investigational Site
Hamamatsu, Shizouka
Pfizer Investigational Site
Higashiibaraki-gun, Ibaraki
Pfizer Investigational Site
Hiroshima, Hiroshima
Pfizer Investigational Site
Hitachi, Ibaraki
Pfizer Investigational Site
Iruma-gun, Saitama
Pfizer Investigational Site
Kagoshima, Kagoshima-ken
Pfizer Investigational Site
Kita-adachi-gun, Saitama
Pfizer Investigational Site
Kitakyushu, Fukuoka
Pfizer Investigational Site
Kobe, Hyōgo
Pfizer Investigational Site
Kōriyama, Fukushima
Pfizer Investigational Site
Koto-ku, Tokyo
Pfizer Investigational Site
Kumamoto, Kumamoto
Pfizer Investigational Site
Kurashiki, Okayama-ken
Pfizer Investigational Site
Kure, Hiroshima
Pfizer Investigational Site
Kurume, Fukuoka
Pfizer Investigational Site
Matsuyama, Ehime
Pfizer Investigational Site
Meguro-ku, Tokyo
Pfizer Investigational Site
Mitaka, Tokyo
Pfizer Investigational Site
Morioka, Iwate
Pfizer Investigational Site
Nagoya, Aichi-ken
Pfizer Investigational Site
Naha, Okinawa
Pfizer Investigational Site
Niigata, Niigata
Pfizer Investigational Site
Osaka, Osaka
Pfizer Investigational Site
Ōta, Gunma
Pfizer Investigational Site
Sagamihara, Kanagawa
Pfizer Investigational Site
Saitama, Saitama
Pfizer Investigational Site
Sakai, Osaka
Pfizer Investigational Site
Sakura, Chiba
Pfizer Investigational Site
Sapporo, Hokkaido
Pfizer Investigational Site
Sendai, Miyagi
Pfizer Investigational Site
Shimotsuke, Tochigi
Pfizer Investigational Site
Shizuoka, Shizuoka
Pfizer Investigational Site
Sunto-gun, Shizuoka
Pfizer Investigational Site
Toyoake, Aichi-ken
Pfizer Investigational Site
Toyohashi, Aiche
Pfizer Investigational Site
Toyota, Aichi-ken
Pfizer Investigational Site
Utsunomiya, Tochigi
Pfizer Investigational Site
Yokohama, Kanagawa

Other trials in Japan

About this study

Official title: A Randomized, Double-Blind, Controlled Study Of Exemestane (Aromasin) Vs Anastrozole (Arimidex) As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer

To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.

Conditions: Breast Neoplasms
Being tested: exemestane, anastrozole
Medical subject headings: Breast Neoplasms

What participants receive

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

exemestaneDrug
take orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal
anastrozoleDrug
take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal

Study groups in NCT00143390
Study group	Role	What they receive
1	Experimental	Not described Receives: Drug: exemestane
2	Experimental	Not described Receives: Drug: anastrozole

What is being measured

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

Time to Progression (TTP) - Expert Evaluation Committee Assessment
Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).
Measured: Up to 2008 days of the treatment

Secondary outcomes (5)

Time to Progression (TTP) - Investigators Assessment
Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the investigator using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).
Measured: Up to 2008 days of the treatment
Number of Participants With Objective Response - Investigators Assessment
Number of participants with objective response based assessment of confirmed complete response (CR) or confirmed partial response (PR) according to Response Evaluation Criteria in Solid Tumors (RECIST version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Objective Response (OR)= CR + PR.
Measured: Up to 2008 days of the treatment
Number of Participants With Clinical Benefit - Investigator Assessment
Number of participants with clinical benefit based assessment of CR, PR or long-term stable disease (SD) according to the RECIST (version 1.0). CR and PR are those that persist on repeat imaging study at least 4 weeks after initial documentation of response. CR was defined as the disappearance of all target and nontarget lesions and no appearance of new lesions. PR was defined as at least a 30% decrease in the sum of the longest diameters (SLD) of the targeted lesions. Long-term SD was defined as SD lasted for at least 24 weeks (168 days). Clinical benefit = CR + PR + long SD
Measured: Up to 2008 days of the treatment
Overall Survival (OS)
OS is defined as time from the date of randomization to the date of death.
Measured: Up to 2008 days of the treatment
Time to Treatment Failure (TTF)
TTF is defined as the time from the randomization to the date of the first documentation of progressive disease (PD), symptomatic deterioration, death due to any cause, or treatment discontinuation due to adverse event, refusal or other reasons.
Measured: Up to 2008 days of the treatment

Timeline

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

Apr 2005Dec 2010

First posted2 Sep 2005 (estimated)
Study startApr 2005
Primary completionDec 2010
Study completionDec 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
More trials run by PfizerThe 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 298 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00143390
Sponsor's protocol ID: A5991048
Status last verified: Dec 2011
First submitted: 1 Sep 2005
Last updated: 25 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

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

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All Breast Neoplasms trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Controlled Study Of Exemestane (Aromasin) Vs Anastrozole (Arimidex) As Initial Hormonal Therapy In Postmenopausal Women With Advanced/Recurrent Breast Cancer
ClinicalTrials.gov ID: NCT00143390
Acronym / sponsor ID: A5991048
Conditions: Breast Neoplasms
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 298 participants (actual)
Lead sponsor: PfizerIndustry (pharma, biotech, devices)
Study start: Apr 2005
Primary completion: Dec 2010 (actual)
Study completion: Dec 2010 (actual)
First posted: 2 Sep 2005 (estimated)
Results: Posted 25 Jan 2012

Clinical summary

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

To verify the non-inferiority of exemestane compared to anastrozole in time to tumor progression (TTP), the primary efficacy endpoint, in postmenopausal women with advanced/recurrent breast cancer.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
1	Experimental	Drug: exemestane
2	Experimental	Drug: anastrozole

Who may qualify

Ages: 20 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (1 listed)

Have histologically or cytologically confirmed breast cancer at original diagnosis. At study entry, the patient must have metastatic progressive or locally recurrent inoperable breast cancer.

Key exclusion criteria (1 listed)

Having received any hormonal therapy (e.g., Tamoxifen, LHRH-agonists) ovariectomy or any chemotherapy for advanced/recurrent breast cancer

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
exemestanetake orally one tablet per day of exemestane 25 mg and one tablet per day of anastrozole placebo daily after meal	Drug	1
anastrozoletake orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal	Drug	2

Primary outcome

Time to Progression (TTP) - Expert Evaluation Committee Assessment
Time frame: Up to 2008 days of the treatment
Time in months from randomization to first documentation of objective tumor progression or death due to breast cancer, whichever comes first. Tumor progression was determined by the expert evaluation committee using RECIST version 1.0 as an at least a 20% increase in the sum of the longest diameters (SLD) of the target lesions compared to the smallest SLD since the study treatment started. For participants with bone metastasis only, at least 25% increase in the measurable lesion according to General Rules for Clinical and Pathological Study of Breast Cancer (The 14th edition).

5 secondary outcomes

Time to Progression (TTP) - Investigators Assessment
Time frame: Up to 2008 days of the treatment
Number of Participants With Objective Response - Investigators Assessment
Time frame: Up to 2008 days of the treatment
Number of Participants With Clinical Benefit - Investigator Assessment
Time frame: Up to 2008 days of the treatment
Overall Survival (OS)
Time frame: Up to 2008 days of the treatment
Time to Treatment Failure (TTF)
Time frame: Up to 2008 days of the treatment

Results and safety

Results posted to the registry on 25 Jan 2012, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Exemestane	149	0
Anastrozole	149	0

Primary outcome: Time to Progression (TTP) - Expert Evaluation Committee Assessment

Time frame: Up to 2008 days of the treatment. Median (95% Confidence Interval). Unit: months

Measure	Exemestane n = 147	Anastrozole n = 145
Value	13.8 (10.8 to 16.5)	11.1 (10.8 to 16.6)

Exemestane vs Anastrozole: Hazard Ratio (HR): 1.007 (95% CI 0.771 to 1.317)

Population analysed: Full Analysis Set (FAS) was defined as participants who were randomized, and administered study medication at least once, and who had at least one efficacy evaluation specified in the protocol.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Up to 2008 days of the treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Exemestane	19 of 149 (12.8%)	120 of 149 (80.5%)	Not reported
Anastrozole	19 of 149 (12.8%)	119 of 149 (79.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingObservational study
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Cardiotoxicity, HER2/Neu Positive
Active, not recruitingPhase 3
ExclUsive endocRine Therapy Or Radiation theraPy for Women Aged ≥70 Years Early Stage Breast Cancer
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RecruitingPhase 1/2
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RecruitingObservational study
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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.

Pfizer CT.gov Call Center study director

Pfizer

47 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing exemestane and anastrozole in people with Breast Neoplasms, run by Pfizer at 47 sites in Japan.

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 1 inclusion and 1 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 25 Jan 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Japan. 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?

Yes. Results are posted in the registry (first posted 25 Jan 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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 Progression (TTP) - Expert Evaluation Committee Assessment (time frame: Up to 2008 days of the treatment). 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 NCT00143390.

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 25 Jan 2012; AzTrials last refreshed its copy on 29 Oct 2026.