MedDataX Logo

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

NCT ID: NCT00143390

Last Updated: 2012-01-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

298 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-04-30

Study Completion Date

2010-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Evaluating The Safety Of Exemestane Following 2-3 Years Of Adjuvant Tamoxifen Therapy In Postmenopausal Early Breast Cancer Patients

NCT01155063

Early Breast Cancer
TERMINATED

Exemestane in Reducing Breast Density in Postmenopausal Women at Risk for Breast Cancer

NCT00066586

Breast Cancer
COMPLETED NA

Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane

NCT00036270

Breast Neoplasms
COMPLETED PHASE3

Open Label, Multicenter, Randomized, Controlled Study of IM or Oral Exemestane (Aromasin) in Postmenopausal Women

NCT00040014

Breast Neoplasms
TERMINATED PHASE2

A Survey Of Clinical Practice Of Adjuvant Treatment Of Breast Cancer Using Exemestane (Aromasin®) In Postmenopausal Hr+ Patients

NCT01305239

Breast Cancer
TERMINATED

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Neoplasms

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Group Type EXPERIMENTAL

exemestane

Intervention Type DRUG

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

2

Group Type EXPERIMENTAL

anastrozole

Intervention Type DRUG

take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

exemestane

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

Intervention Type DRUG

anastrozole

take orally one tablet of anastrozole 1 mg and one tablet of exemestane placebo daily after meal

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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.

Exclusion Criteria

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

20 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Pfizer

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Pfizer CT.gov Call Center

Role: STUDY_DIRECTOR

Pfizer

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Pfizer Investigational Site

Toyohashi, Aiche, Japan

Site Status

Pfizer Investigational Site

Anjo, Aichi-ken, Japan

Site Status

Pfizer Investigational Site

Nagoya, Aichi-ken, Japan

Site Status

Pfizer Investigational Site

Toyoake, Aichi-ken, Japan

Site Status

Pfizer Investigational Site

Toyota, Aichi-ken, Japan

Site Status

Pfizer Investigational Site

Chiba, Chiba, Japan

Site Status

Pfizer Investigational Site

Sakura, Chiba, Japan

Site Status

Pfizer Investigational Site

Matsuyama, Ehime, Japan

Site Status

Pfizer Investigational Site

Fukuoka, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Kitakyushu, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Kurume, Fukuoka, Japan

Site Status

Pfizer Investigational Site

Kōriyama, Fukushima, Japan

Site Status

Pfizer Investigational Site

Ōta, Gunma, Japan

Site Status

Pfizer Investigational Site

Hiroshima, Hiroshima, Japan

Site Status

Pfizer Investigational Site

Kure, Hiroshima, Japan

Site Status

Pfizer Investigational Site

Sapporo, Hokkaido, Japan

Site Status

Pfizer Investigational Site

Akashi, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Amagasaki, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Kobe, Hyōgo, Japan

Site Status

Pfizer Investigational Site

Higashiibaraki-gun, Ibaraki, Japan

Site Status

Pfizer Investigational Site

Hitachi, Ibaraki, Japan

Site Status

Pfizer Investigational Site

Morioka, Iwate, Japan

Site Status

Pfizer Investigational Site

Kagoshima, Kagoshima-ken, Japan

Site Status

Pfizer Investigational Site

Sagamihara, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Yokohama, Kanagawa, Japan

Site Status

Pfizer Investigational Site

Kumamoto, Kumamoto, Japan

Site Status

Pfizer Investigational Site

Sendai, Miyagi, Japan

Site Status

Pfizer Investigational Site

Niigata, Niigata, Japan

Site Status

Pfizer Investigational Site

Kurashiki, Okayama-ken, Japan

Site Status

Pfizer Investigational Site

Naha, Okinawa, Japan

Site Status

Pfizer Investigational Site

Osaka, Osaka, Japan

Site Status

Pfizer Investigational Site

Sakai, Osaka, Japan

Site Status

Pfizer Investigational Site

Iruma-gun, Saitama, Japan

Site Status

Pfizer Investigational Site

Kita-adachi-gun, Saitama, Japan

Site Status

Pfizer Investigational Site

Saitama, Saitama, Japan

Site Status

Pfizer Investigational Site

Hamamatsu, Shizouka, Japan

Site Status

Pfizer Investigational Site

Shizuoka, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Sunto-gun, Shizuoka, Japan

Site Status

Pfizer Investigational Site

Shimotsuke, Tochigi, Japan

Site Status

Pfizer Investigational Site

Utsunomiya, Tochigi, Japan

Site Status

Pfizer Investigational Site

Bunkyo-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Chiyoda-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Chuo-Ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Koto-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Meguro-ku, Tokyo, Japan

Site Status

Pfizer Investigational Site

Mitaka, Tokyo, Japan

Site Status

Pfizer Investigational Site

Chiba, , Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

A5991048

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Exemestane As Treatment In Adjuvant For Post-Menopausal Patients With Non-Metastatic Breast Cancer
NCT00279448 COMPLETED PHASE3
Antiestrogen vs Aromatase Inhibitor After Adjuvant Chemotherapy for Breast Cancer
NCT00437359 TERMINATED PHASE2
Aromasin® Interventional Study Of Early Invasive Breast Cancer Patients In China
NCT01176916 COMPLETED PHASE4
Exemestane (Aromasine) + Tamoxifen - Breast Neo-Adjuvant
NCT00919399 COMPLETED PHASE2
Randomized Trial Of Exemestane Versus Continued Tamoxifen In Postmenopausal Women With Early Breast Cancer
NCT00038467 COMPLETED PHASE3
Sequencing Of Endocrine Therapy In Post-Menopausal Women With Early Breast Cancer (FAST)
NCT01050634 COMPLETED
Exemestane As Treatment In Neoadjuvant Setting For Operable Breast Cancer Patients
NCT00174343 COMPLETED PHASE2
Effects of Adjuvant Endocrine Therapy With Aromatase Inhibitors on the Postoperative Lipid Levels in Postmenopausal Breast Cancer Patients
NCT02765373 UNKNOWN
Alternative Dosing of Exemestane Before Surgery in Treating Postmenopausal Patients With Stage 0-II Estrogen Positive Breast Cancer
NCT02598557 COMPLETED PHASE2
Arimidex/Tamoxifen Neo Adjuvant Study in Premenopausal Patients With Breast Cancer Under Anti Hormonal Treatment
NCT00605267 COMPLETED PHASE3
Non-interventional Study to Evaluate Arimidex in Postmenopausal Women With Advanced Breast Cancer
NCT00562458 COMPLETED
Study in Post-menopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
NCT03176238 COMPLETED PHASE3
The Evaluation of the Efficacy and Tolerability of FASLODEX (Fulvestrant) and AROMASIN (Exemestane) in Hormone Receptor Positive Postmenopausal Women With Advanced Breast Cancer
NCT00065325 COMPLETED PHASE3
Suppression of Ovarian Function With Either Tamoxifen or Exemestane Compared With Tamoxifen Alone in Treating Premenopausal Women With Hormone-Responsive Breast Cancer
NCT00066690 COMPLETED PHASE3
A Study to Evaluate the Safety of Adjuvant Treatment With Exemestane Following Previous Treatment With Tamoxifen in Postmenopausal Women With Estrogen Sensitive Primary Breast Cancer
NCT00649090 COMPLETED PHASE4
A Study of Nonsteroidal Aromatase Inhibitors Plus Abemaciclib (LY2835219) in Postmenopausal Women With Breast Cancer
NCT02246621 ACTIVE_NOT_RECRUITING PHASE3
Everolimus in Combination With Exemestane in the Treatment of Postmenopausal Women With Estrogen Receptor Positive Locally Advanced or Metastatic Breast Cancer Who Are Refractory to Letrozole or Anastrozole
NCT00863655 COMPLETED PHASE3
Aromasin® As Adjuvant Treatment In Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer
NCT01239745 TERMINATED
Circulating miRNAs as Biomarkers of Hormone Sensitivity in Breast Cancer
NCT01612871 COMPLETED PHASE4
Bioequivalence Study Comparing Arimidex Tablet and Anastrozole ODF in Japanese Healthy Male Subjects
NCT01568281 COMPLETED PHASE1
Exemestane + Celecoxib vs Exemestane + Placebo in Metastatic Breast Cancer
NCT00525096 COMPLETED PHASE3
Breast Density, Hormone Levels, and Anticancer Drug Levels in Women With Invasive Breast Cancer Who Are Receiving Exemestane or Anastrozole
NCT00316836 COMPLETED
Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer
NCT00032136 COMPLETED PHASE3
Effect of Endocrine Therapy Duration on Clinical Outcome of Patients With HR+ Intraductal Carcinoma of the Breast
NCT04666805 UNKNOWN
Letrozole, Anastrozole, Exemestane, or Tamoxifen Citrate in Treating Postmenopausal Women With Breast Cancer
NCT00893061 COMPLETED PHASE3