Metastatic Breast Cancer
Conditions
Keywords
Metastatic Breast Cancer, Advanced, Postmenopausal, Exemestane vs Megestrol
Brief summary
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.
Interventions
DRUGMegestrol acetate
Megestrol Acetate 160 mg oral tablets Qd
exemestane (Aromasin) 25 mg oral tablets Qd
Sponsors
Pfizer
Study design
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Previous participation in study 971-ONC-0028-080.
Exclusion criteria
* Subjects who had not previously participated in study 971-ONC-0028-080.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Every 12 weeks up to 6 years | Overall survival in months measured from date of starting treatment in core study to date of death for any reason. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) | Every 12 weeks up to 6 years | 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 Response (DR) | Every 12 weeks up to 6 years | 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 to Tumor Progression (TTP) | Every 12 weeks up to 6 years | 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 to Treatment Failure (TTF) | Every 12 weeks up to 6 years | 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. |
Countries
China
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Exemestane Exemestane 25 milligram (mg) oral tablet taken once daily | 43 |
| Megestrol Acetate Megestrol acetate 160 mg tablet taken once daily | 41 |
| Total | 84 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Completed 26 weeks treatment:Core Study | 3 | 2 |
| Overall Study | Lost to Follow-up | 3 | 0 |
| Overall Study | Progression of Disease: Core Study | 18 | 22 |
| Overall Study | Progression of Disease: Extension Study | 15 | 13 |
| Overall Study | Protocol Specific Withdrawal Criteria | 1 | 0 |
| Overall Study | Protocol Violation: Core Study | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 3 |
Baseline characteristics
| Characteristic | Exemestane | Megestrol Acetate | Total |
|---|---|---|---|
| Age, Customized 50 to 64 years | 17 participants | 24 participants | 41 participants |
| Age, Customized < 50 years | 10 participants | 15 participants | 25 participants |
| Age, Customized 65 to 79 years | 16 participants | 2 participants | 18 participants |
| Sex: Female, Male Female | 43 Participants | 41 Participants | 84 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 24 / 41 | 25 / 40 |
| serious Total, serious adverse events | 1 / 41 | 2 / 40 |
Outcome results
Primary
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
Population: Intent-to-treat (ITT): participants randomized to study medication in core study who consented to participation in extension study.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exemestane | Overall Survival | 29.2 months |
| Megestrol Acetate | Overall Survival | 16.3 months |
Comparison: Overall survival compared using the hazard ratio; hazard ratio \<1.0 is in favor of exemestane.p-value: 0.334895% CI: [0.47, 1.294]Log Rank
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.
Time frame: Every 12 weeks up to 6 years
Population: ITT.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exemestane | Duration of Response (DR) | 12.9 months |
| Megestrol Acetate | Duration of Response (DR) | 35.4 months |
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
Time frame: Every 12 weeks up to 6 years
Population: ITT
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exemestane | Objective Response Rate (ORR) | 23.3 percentage of participants |
| Megestrol Acetate | Objective Response Rate (ORR) | 12.2 percentage of participants |
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.
Time frame: Every 12 weeks up to 6 years
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exemestane | Time to Treatment Failure (TTF) | 6.0 months |
| Megestrol Acetate | Time to Treatment Failure (TTF) | 3.7 months |
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.
Time frame: Every 12 weeks up to 6 years
Population: ITT
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Exemestane | Time to Tumor Progression (TTP) | 6.0 months |
| Megestrol Acetate | Time to Tumor Progression (TTP) | 3.7 months |