Neoplasms

Skin and Connective Tissue Diseases

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Breast Neoplasms

Breast Diseases

Skin Diseases

Bone Density Conservation Agents

Antineoplastic Agents

All Drugs and Chemicals

Tamoxifen

Exemestane

Estrogens

Estrogen Antagonists

Estrogen Receptor Antagonists

Hormones

Hormone Antagonists

Antineoplastic Agents, Hormonal

Selective Estrogen Receptor Modulators

Estrogen Receptor Modulators

Aromatase Inhibitors

Enzyme Inhibitors

exemestane (Aromasin)

tamoxifen, 20 mg, orally, daily, 2-3 years; followed by exemestane, orally, 25 mg, for a total of 5 years of therapy

tamoxifen + exemestane

Pfizer CT.gov Call Center

To compare the effects of exemestane for 5 years versus tamoxifen and exemestane given sequentially over 5 years in the adjuvant treatment of postmenopausal women with early breast cancer.

This Pfizer sponsored trial is part of an international collaboration of investigators conducting 7 similar yet independent studies in 9 countries. This study is designed to be part of the larger TEAM trial where the data from these 7 studies will be combined. A pre-specified analysis of the pooled data will be conducted.

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

Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen For 2.5- 3 Years Followed By Exemestane (Aromasin) For A Total Of 5 Years As Adjuvant Therapy For Postmenopausal, Receptor Positive, Node Negative or Node Positive Breast Cancer Patients

Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 2.75 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.

Number of events (disease relapse or death) to time of observation for DFS. DFS defined as time from randomization to earliest documentation of disease relapse or death from any cause in postmenopausal, receptor positive, node negative or node positive breast cancer patients for adjuvant treatment with exemestane compared with adjuvant tamoxifen therapy at 5 years. Disease relapse: primary tumor recurrence (locoregional or distant) and ipsilateral or contralateral breast cancer (CBC). Intercurrent death: death without disease relapse.

Number of events (death) to time of observation for OS. OS is the duration from randomization to death. For participants who are alive, overall survival is censored at the last contact.

New primary breast cancers were defined as events of ipsilateral/contralateral breast cancer (CBC).

Number of events to time of observation for relapse. Relapse is defined as all recurrences of the primary tumor (loco-regional and distant recurrence), second primary breast cancer, contralateral breast cancer.

Number of participants with new primary non-breast cancers which included colorectal cancer, lung cancer, endometrial cancer, ductal carcinoma in situ (DCIS) and other primary cancer types.

Pfizer

The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.

Tamoxifen 20 mg QD; upon completing 2.5 years to 3 years of tamoxifen, participants were to be switched to exemestane 25 mg QD and then were to complete a total of 5 years endocrine therapy.

Tamoxifen Followed by Exemestane

Exemestane (Aromasin®) 25 mg QD for 5 years

Exemestane (Aromasin®) 25 mg QD for 5 years.

Total

Age, Continuous

Less than 50 years

50 to 59 years

60 to 69 years

Greater than and equal to 70 years

Age, Customized

Sex: Female, Male

Overall Survival was reported as number of events which otherwise reported as time.

Pfizer ClinicalTrials.gov Call Center

Analysis at 2.75 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 2.75 years.

To maintain overall alpha of 0.05, 2 adjustments made: first, a nominal alpha of 0.0302 was used for the primary endpoint. Second, level of significant was 0.0012 for interim analysis.

Intent-to-Treat (ITT) population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at 2.75 years.

Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 2.75 Years

Analysis at 5 years post-randomization. Null hypothesis: no difference in DFS between the two treatments for the first 5 years.

To maintain overall alpha of 0.05, a nominal alpha of 0.0302 was used.

ITT population included all participants who were randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.

Disease Free Survival (DFS): Number of Events (Disease Relapse or Death) From Baseline up to 5 Years

Analysis at 5 years post-randomization. Null hypothesis: no difference in OS between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.

ITT population: participants randomized to one of the two study arms (all randomized participants); (n) = number of participants at observation for exemestane and tamoxifen, respectively. All participants were censored at the data cut off date of 08 November 2009.

Number of Events for Overall Survival (OS)

Data was not analyzed due to insufficient number of events reported for the endpoint.

Time to New Primary Breast Cancers

Analysis at 5 years post-randomization. Null hypothesis: no difference in time to relapse between the two treatments for the first 5 years. Overall alpha of 0.05 was maintained.

Number of Events for Time to Relapse

Colorectal cancer

Lung cancer

Endometrial cancer

DCIS

Other primary cancer types

Number of Participants With New Primary Non-breast Cancers

Exemestane (Aromasin®) 25 milligram (mg) once daily (QD) for 5 years.

Randomized to Study Treatment

Study Treatment to 5 Year Report

Reproductive Control Agents

Central Nervous System Stimulants

Megestrol

Megestrol Acetate

Contraceptive Agents

Contraceptives, Oral

Contraceptives, Oral, Hormonal

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Megestrol acetate

exemestane (Aromasin) 25 mg oral tablets Qd

Long term efficacy of exemestane as compared to megestrol acetate in the treatment of women with natural or induced postmenopausal status with advanced breast cancer whose disease has progressed following anti-estrogens or anti-estrogens plus chemotherapy and who had participated on an original study of exemestane vs megestrol : study 971-ONC-0028-080.

Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer

Follow-up of the Study 971-ONC-0028-080: Exemestane Versus Megestrol Acetate In Postmenopausal Patients With Metastatic Breast Cancer, Failing Anti-Estrogens: An Open-Label, Randomized, Parallel-Group, Phase III Comparative Study

Overall survival in months measured from date of starting treatment in core study to date of death for any reason.

Percentage of participants achieving an objective response (OR) defined as complete response (CR) or partial response (PR) out of the total number of participants randomized in each treatment group

Duration of objective response (complete response \[CR\] or partial response \[PR\]) calculated from date objective response was first documented to date of progressive disease. For subjects proceeding from PR to CR, the onset of PR was taken as the onset of objective response.

TTP = time between first day of study treatment and date of documented disease progression, or date of tumor-related death in the absence of previously documented progressive disease (PD). PD defined as a 25% or greater increase in size of 1 or more lesions compared to smallest previous assessment, or appearance of new lesion, or unequivocal worsening of bone lesions, or progression of nonevaluable lesions.

TTF = time between first day of study treatment and date of diagnosis of progression, withdrawal from study treatment for any reason, administration of other antitumor treatment, or death from any cause, whichever was the earliest event.

Director, Clinical Trial Disclosure Group

Exemestane 25 milligram (mg) oral tablet taken once daily

Megestrol acetate 160 mg tablet taken once daily

< 50 years

50 to 64 years

65 to 79 years

At the time of study completion in 2007, via protocol amendment participants still on treatment were allowed to continue treatment, being monitored for Serious Adverse Events (SAE) only. The final participant discontinued in 2009.

Overall survival compared using the hazard ratio; hazard ratio \<1.0 is in favor of exemestane.

Intent-to-treat (ITT): participants randomized to study medication in core study who consented to participation in extension study.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane	NCT00036270	Breast Neoplasm...	exemestane (Aro... tamoxifen + exe...	50 Years -	Pfizer
Randomized Phase III Study Of Exemestane (Aromasin) For 5 Years Versus Tamoxifen for 2.5 to 3 Years Followed By Exemestane	NCT00036270	Breast Neoplasm...	exemestane (Aro... tamoxifen + exe...	50 Years -	Pfizer
Multicenter Follow Up Study Of Subjects Who Participated In An Original Protocol Of Exemestane Vs. Megestrol Acetate In Postmenopausal Women With Metastatic Breast Cancer	NCT01237327	Metastatic Brea...	Megestrol aceta... exemestane (Aro...	-	Pfizer

Spots Global Cancer Trial Database for exemestane (aromasin)