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| ID | Type | Description | Link |
|---|---|---|---|
| A5991027 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Active Comparator |
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| 2 | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Megestrol acetate | Drug | Megestrol Acetate 160 mg oral tablets Qd |
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| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival | Overall survival in months measured from date of starting treatment in core study to date of death for any reason. | Every 12 weeks up to 6 years |
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) | 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 | Every 12 weeks up to 6 years |
| Duration of Response (DR) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Institute and Hospital, Chinese Academy of Medical Sciences | Beijing | 100021 | China | |||
| PLA 307 Hospital |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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Follow-up study for participants in core study who completed 26 weeks of treatment, progressed while on therapy, or dropped out for any reason. Those who benefitted from core study treatment continued according to original randomization. Those who dropped out of core study received therapy appropriate for disease and were followed for survival.
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| ID | Title | Description |
|---|---|---|
| FG000 | Exemestane | Exemestane 25 milligram (mg) oral tablet taken once daily |
| FG001 | Megestrol Acetate | Megestrol acetate 160 mg tablet taken once daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| exemestane (Aromasin) | Drug | exemestane (Aromasin) 25 mg oral tablets Qd |
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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. |
| Every 12 weeks up to 6 years |
| Time to Tumor Progression (TTP) | 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. | Every 12 weeks up to 6 years |
| Time to Treatment Failure (TTF) | 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. | Every 12 weeks up to 6 years |
| Beijing |
| 100039 |
| China |
| Ba Yi Hospital, Cancer Center of CPLA | Nanjing | 210002 | China |
| Jiangsu Cancer Hospital | Nanjing | 210009 | China |
| Cancer Hospital | Shanghai | 200032 | China |
| The 2nd Central Hospital of Tianjin | Tianjin | 300120 | China |
| The 1st Affiliated Hospital, Xi'an Jiao Tong University | Xi'an | 710061 | China |
| Stopped Treatment in Core Study (D/C) |
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| Completed Treatment in Core Study |
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| Continued Treatment in Extension Study |
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| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Exemestane | Exemestane 25 milligram (mg) oral tablet taken once daily |
| BG001 | Megestrol Acetate | Megestrol acetate 160 mg tablet taken once daily |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number | participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival | Overall survival in months measured from date of starting treatment in core study to date of death for any reason. | Intent-to-treat (ITT): participants randomized to study medication in core study who consented to participation in extension study. | Posted | Median | 95% Confidence Interval | months | Every 12 weeks up to 6 years |
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| Secondary | Objective Response Rate (ORR) | 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 | ITT | Posted | Number | percentage of participants | Every 12 weeks up to 6 years |
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| Secondary | Duration of Response (DR) | 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. | ITT. | Posted | Median | 95% Confidence Interval | months | Every 12 weeks up to 6 years |
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| Secondary | Time to Tumor Progression (TTP) | 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. | ITT | Posted | Median | 95% Confidence Interval | months | Every 12 weeks up to 6 years |
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| Secondary | Time to Treatment Failure (TTF) | 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. | ITT | Posted | Median | 95% Confidence Interval | months | Every 12 weeks up to 6 years |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Exemestane | Exemestane 25 milligram (mg) oral tablet taken once daily | 1 | 41 | 24 | 41 | ||
| EG001 | Megestrol Acetate | Megestrol acetate 160 mg tablet taken once daily | 2 | 40 | 25 | 40 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Chest pain NEC | General disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Cerebral haemorrhage | Nervous system disorders | MedDRA | Systematic Assessment |
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| Headache NOS | Nervous system disorders | MedDRA | Systematic Assessment |
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| Spinal cord compression | Nervous system disorders | MedDRA | Systematic Assessment |
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| Completed suicide | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Supraventricular extrasystoles | Cardiac disorders | MedDRA | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Mouth ulceration | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
| |
| Chest pain NEC | General disorders | MedDRA | Systematic Assessment |
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| Fatigue | General disorders | MedDRA | Systematic Assessment |
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| Pain NOS | General disorders | MedDRA | Systematic Assessment |
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| Thirst | General disorders | MedDRA | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA | Systematic Assessment |
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| Aspartate aminotransferase | Investigations | MedDRA | Systematic Assessment |
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| Weight increased | Investigations | MedDRA | Systematic Assessment |
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| Hypercholesterolaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Bone pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
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| Hypoaesthesia | Nervous system disorders | MedDRA | Systematic Assessment |
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| Vaginal haemorrhage | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Dyspnoea NOS | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Face eodema | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Nail discolouration | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Pigmentation disorder | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Sweating increased | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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| Flushing | Vascular disorders | MedDRA | Systematic Assessment |
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| Oedema NOS | Cardiac disorders | MedDRA | Systematic Assessment |
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| Tachycardia NOS | Cardiac disorders | MedDRA | Systematic Assessment |
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| Abdominal pain NOS | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA | Systematic Assessment |
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| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
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| Chest mass NOS | General disorders | MedDRA | Systematic Assessment |
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| Oedema NOS | General disorders | MedDRA | Systematic Assessment |
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| Infection NOS | Infections and infestations | MedDRA | Systematic Assessment |
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| Humerus fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
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| Alanine aminotransferase | Investigations | MedDRA | Systematic Assessment |
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| Gamma-glutamyltransferase | Investigations | MedDRA | Systematic Assessment |
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| Weight decreased | Investigations | MedDRA | Systematic Assessment |
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| Diabetes mellitus NOS | Metabolism and nutrition disorders | MedDRA | Systematic Assessment |
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| Chest wall pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
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| Dizziness (exc vertigo) | Nervous system disorders | MedDRA | Systematic Assessment |
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| Headache NOS | Nervous system disorders | MedDRA | Systematic Assessment |
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| Insomnia NEC | Nervous system disorders | MedDRA | Systematic Assessment |
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| Peripheral motor neuropathy | Nervous system disorders | MedDRA | Systematic Assessment |
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| Spinal cord compression | Nervous system disorders | MedDRA | Systematic Assessment |
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| Mood alteration NOS | Psychiatric disorders | MedDRA | Systematic Assessment |
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| Dysuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Urinary frequency | Renal and urinary disorders | MedDRA | Systematic Assessment |
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| Breast mass NOS | Reproductive system and breast disorders | MedDRA | Systematic Assessment |
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| Haemoptysis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA | Systematic Assessment |
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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 has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D019290 | Megestrol Acetate |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D008535 | Megestrol |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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| Title | Measurements |
|---|---|
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| 65 to 79 years |
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| Male |
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