Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Reproductive Control Agents

Central Nervous System Stimulants

Exemestane

Estrogens

Megestrol

Megestrol Acetate

Estrogen Receptor Modulators

Estrogen Antagonists

Estrogen Receptor Antagonists

Aromatase Inhibitors

Enzyme Inhibitors

Hormones

Hormone Antagonists

Contraceptive Agents

Contraceptives, Oral

Contraceptives, Oral, Hormonal

Contraceptive Agents, Female

Contraceptive Agents, Hormonal

Antineoplastic Agents, Hormonal

Megestrol acetate

exemestane (Aromasin) 25 mg oral tablets Qd

exemestane (Aromasin)

Pfizer CT.gov Call Center

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.

Pfizer

Director, Clinical Trial Disclosure Group

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.

Exemestane 25 milligram (mg) oral tablet taken once daily

Megestrol acetate 160 mg tablet taken once daily

Total

< 50 years

50 to 64 years

65 to 79 years

Age, Customized

Sex: Female, Male

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.

Pfizer ClinicalTrials.gov Call Center

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.

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

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

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