A Phase 3 interventional study of Megestrol acetate and exemestane (Aromasin) in Metastatic Breast Cancer, sponsored by Pfizer. Completed at 7 sites in China. Open to female participants. Per ClinicalTrials.gov, last updated 2011-05-06.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 84 is above the median of 72 across 9,302 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Drug: Megestrol acetate
Drug: exemestane (Aromasin)
Megestrol Acetate 160 mg oral tablets Qd
Also known as: Megace
exemestane (Aromasin) 25 mg oral tablets Qd
Also known as: Aromasin
Overall Survival
Overall survival in months measured from date of starting treatment in core study to date of death for any reason.
Time frame: Every 12 weeks up to 6 years
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
Time frame: Every 12 weeks up to 6 years
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.
Time frame: 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.
Time frame: 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.
Time frame: Every 12 weeks up to 6 years
| Milestone | Exemestane | Megestrol Acetate |
|---|---|---|
| Started | 43 | 41 |
| Stopped treatment in core study (d/c) | 22 | 24 |
| Completed treatment in core study | 3 | 2 |
| Continued treatment in extension study | 21 | 17 |
| Completed | 1 | 1 |
| Not completed | 42 | 40 |
| Withdrew: Protocol violation: core study | 1 | 0 |
| Withdrew: Completed 26 weeks treatment:core study | 3 | 2 |
| Withdrew: Progression of disease: core study | 18 | 22 |
| Withdrew: Progression of disease: extension study | 15 | 13 |
| Withdrew: Protocol specific withdrawal criteria | 1 | 0 |
| Withdrew: Withdrawal by subject | 1 | 3 |
| Withdrew: Lost to follow-up | 3 | 0 |
Overall survival in months measured from date of starting treatment in core study to date of death for any reason.
| months | Exemestane | Megestrol Acetate |
|---|---|---|
| Overall Survival | 29.2 (22.9 to 47.8) | 16.3 (11.6 to 27.6) |
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
| percentage of participants | Exemestane | Megestrol Acetate |
|---|---|---|
| Objective Response Rate (ORR) | 23.3 | 12.2 |
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.
| months | Exemestane | Megestrol Acetate |
|---|---|---|
| Duration of Response (DR) | 12.9 (10.8 to 49.0) | 35.4 (23.6 to NA) |
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.
| months | Exemestane | Megestrol Acetate |
|---|---|---|
| Time to Tumor Progression (TTP) | 6.0 (3.7 to 13.0) | 3.7 (2.1 to 8.9) |
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.
| months | Exemestane | Megestrol Acetate |
|---|---|---|
| Time to Treatment Failure (TTF) | 6.0 (3.7 to 11.4) | 3.7 (2.1 to 8.8) |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Exemestane | — | 1/41 (2.4%) | 24/41 (58.5%) |
| Megestrol Acetate | — | 2/40 (5%) | 25/40 (62.5%) |
| Event | Exemestane | Megestrol Acetate |
|---|---|---|
| Chest pain NECGeneral disorders | 0/41 | 1/40 |
| Back painMusculoskeletal and connective tissue disorders | 0/41 | 1/40 |
| Cerebral haemorrhageNervous system disorders | 0/41 | 1/40 |
| Headache NOSNervous system disorders | 0/41 | 1/40 |
| Spinal cord compressionNervous system disorders | 0/41 | 1/40 |
| Completed suicidePsychiatric disorders | 1/41 | 0/40 |
| Event | Exemestane | Megestrol Acetate |
|---|---|---|
| FatigueGeneral disorders | 1/41 | 6/40 |
| NauseaGastrointestinal disorders | 6/41 | 2/40 |
| Weight increasedInvestigations | 3/41 | 5/40 |
| CoughRespiratory, thoracic and mediastinal disorders | 5/41 | 4/40 |
| Sweating increasedSkin and subcutaneous tissue disorders | 5/41 | 4/40 |
| FlushingVascular disorders | 5/41 | 0/40 |
| Bone painMusculoskeletal and connective tissue disorders | 2/41 | 3/40 |
| InfluenzaInfections and infestations | 3/41 | 1/40 |
| Dyspnoea NOSRespiratory, thoracic and mediastinal disorders | 3/41 | 2/40 |
| Chest pain NECGeneral disorders | 1/41 | 2/40 |
| Age, Customized(participants) | Exemestane | Megestrol Acetate | Total |
|---|---|---|---|
| < 50 years | 10 | 15 | 25 |
| 50 to 64 years | 17 | 24 | 41 |
| 65 to 79 years | 16 | 2 | 18 |
| Sex: Female, Male(Participants) | Exemestane | Megestrol Acetate | Total |
|---|---|---|---|
| Female | 43 | 41 | 84 |
| Male | 0 | 0 | 0 |
This study is completed, as verified in May 2011. You cannot join it, but the record below documents what was studied.
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