Breast Neoplasms
Conditions
Brief summary
The objective of this surveillance is to collect information about 1) adverse drug reaction not expected from the LPD (unknown adverse drug reaction), 2) the incidence of adverse drug reactions in this surveillance, and 3)factors considered to affect the safety and/or efficacy of this drug.
Detailed description
All the patients whom an investigator prescribes the first Exemestane (Aromasin) should be registered.
Interventions
DRUGExemestane
Aromasin® Tablets 25mg, depending on the Investigator prescription. Frequency and duration are according to Package Insert as follows. The usual adult dose is 25 mg of exemestane administered orally once daily after a meal.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Subjects with postmenopausal breast cancer (including ovariectomy etc.).
Exclusion criteria
* Patients cannot be evaluated.For example, not administered Exemestane (Aromasin).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status | 24 weeks | — |
| Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane | 24 weeks | Scale 0; Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1; Symptomatic but completely ambulatory (Restricted in physically strenuous activity ,ambulatory and able to carry out light or sedentary work), 2 ; Symptomatic, \<50% in bed during the day (Ambulatory,capable of all self care, unable to carry out any work activities., 3; Symptomatic, \>50% in bed, not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more waking hours), 4; Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair) |
| Number of Participants With Adverse Drug Reaction | 24 weeks | Confirmation of the number of subjects with treatment related adverse events. All adverse events regardless of causal relationship with Aromasin Tablet at the end of observation period was reported. |
| Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment | 24 weeks | Anti-tumor effect was evaluated according to the rules for 'General Rules for Clinical and Pathological Recording of Breast Cancer' (the 15th edition)/Response Evaluation Criteria in Solid Tumors (RECIST) Guideline. Judged as Completed response (CR) or partial response (PR), stable disease (SD) or progressive disease (PD) after the treatment start. |
| Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane | 24 weeks | Assessment of factors likely to affect the safety and/or efficacy: reason for Exemestane use (primary progressive breast cancer, relapsed breast cancer or postoperative adjuvant therapy)and past history (presence or absence of at least one disease). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction | 24 weeks | The participants who were diagnosed by the investigator as the participants with hepatic dysfunction, and observed for safety information. |
| Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction | 24 weeks | The participants who were diagnosed by the investigator as the participants with renal dysfunction, and observed for safety information. |
| Number of Participants With Unexpected Adverse Drug Reaction | 24 weeks | Adverse drug reaction that is not included in the precautions for useor undesirable effects section in the package insert (same as Local Product Document). |
Participant flow
Recruitment details
Patients need to be administered Exemestane (Aromasin) in order to be enrolled in the surveillance.
Participants by arm
| Arm | Count |
|---|---|
| Exemestane Exemestane(Aromasin) as prescribed by subject's physician | 450 |
| Total | 450 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 1 |
Baseline characteristics
| Characteristic | Exemestane |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 181 Participants |
| Age, Categorical Between 18 and 65 years | 269 Participants |
| Age Continuous | 62.67 years STANDARD_DEVIATION 9.83 |
| Region of Enrollment Japan | 450 participants |
| Sex: Female, Male Female | 450 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 58 / 450 |
| serious Total, serious adverse events | 2 / 450 |
Outcome results
Primary
Number of Participants With Adverse Drug Reaction
Confirmation of the number of subjects with treatment related adverse events. All adverse events regardless of causal relationship with Aromasin Tablet at the end of observation period was reported.
Time frame: 24 weeks
Population: Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exemestane | Number of Participants With Adverse Drug Reaction | 58 participants |
Primary
Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane
Assessment of factors likely to affect the safety and/or efficacy: reason for Exemestane use (primary progressive breast cancer, relapsed breast cancer or postoperative adjuvant therapy)and past history (presence or absence of at least one disease).
Time frame: 24 weeks
Population: Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane | Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane | Primary Progressive Breast Cancer | 126 participants |
| Exemestane | Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane | Post-operative Adjuvant Therapy | 324 participants |
| Exemestane | Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane | Past history (nothing at all) | 372 participants |
| Exemestane | Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane | Past history (presence of at least one disease) | 68 participants |
| Exemestane | Number of Participants With Factors Considered to Affect the Safety and/or Efficacy of Exemestane | Unknown history | 10 participants |
Primary
Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane
Scale 0; Asymptomatic (Fully active, able to carry on all predisease activities without restriction), 1; Symptomatic but completely ambulatory (Restricted in physically strenuous activity ,ambulatory and able to carry out light or sedentary work), 2 ; Symptomatic, \<50% in bed during the day (Ambulatory,capable of all self care, unable to carry out any work activities., 3; Symptomatic, \>50% in bed, not bedbound (Capable of only limited self-care, confined to bed or chair 50% or more waking hours), 4; Bedbound (Completely disabled. Cannot carry on any self-care. Totally confined to bed or chair)
Time frame: 24 weeks
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane | Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane | Asymptomatic | 385 participants |
| Exemestane | Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane | Symptomatic, completely ambulatory | 47 participants |
| Exemestane | Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane | Symptomatic, <50% in bed during the day | 9 participants |
| Exemestane | Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane | Symptomatic, >50% in bed | 6 participants |
| Exemestane | Number of Participants With Performance Status Score Based on Eastern Cooperative Oncology Group (ECOG) Factors Considered to Affect the Safety and/or Efficacy of Exemestane | Bedbound | 3 participants |
Primary
Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status
Time frame: 24 weeks
Population: The participants who were evaluated for efficacy of Aromasin for the post-operative adjuvant therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane | Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status | Recurrence present | 3 participants |
| Exemestane | Number of Post-operative Adjuvant Therapy Participants With Breast Cancer Recurrence Status | Recurrence absent | 317 participants |
Primary
Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment
Anti-tumor effect was evaluated according to the rules for 'General Rules for Clinical and Pathological Recording of Breast Cancer' (the 15th edition)/Response Evaluation Criteria in Solid Tumors (RECIST) Guideline. Judged as Completed response (CR) or partial response (PR), stable disease (SD) or progressive disease (PD) after the treatment start.
Time frame: 24 weeks
Population: N = number of participants with tumor response
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane | Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment | Completed response (CR) | 1 participants |
| Exemestane | Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment | Partial response (PR) | 5 participants |
| Exemestane | Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment | Stable disease (SD) | 12 participants |
| Exemestane | Number of Tumor Responders in Progressive Breast Cancer or Recurrent Breast Cancer to Exemestane Treatment | Progressive disease (PD) | 32 participants |
Secondary
Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction
The participants who were diagnosed by the investigator as the participants with hepatic dysfunction, and observed for safety information.
Time frame: 24 weeks
Population: Subjects with hepatic Dysfunction.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane | Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction | Hot flush | 1 participants |
| Exemestane | Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction | Abdominal discomfort | 1 participants |
| Exemestane | Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction | Rash | 1 participants |
| Exemestane | Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction | Arthralgia | 1 participants |
| Exemestane | Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction | Musculoskeletal stiffness | 1 participants |
| Exemestane | Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction | Aspartate aminotransferase increased | 1 participants |
| Exemestane | Number of Participants With Adverse Drug Reaction for Subjects With Hepatic Dysfunction | Gamma-glutamyltransferase increased | 1 participants |
Secondary
Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction
The participants who were diagnosed by the investigator as the participants with renal dysfunction, and observed for safety information.
Time frame: 24 weeks
Population: Subjects with renal Dysfunction.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane | Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction | Hot flush | 1 participants |
| Exemestane | Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction | Hepatic function abnormal | 1 participants |
| Exemestane | Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction | Osteoporosis | 2 participants |
| Exemestane | Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction | Back pain | 1 participants |
| Exemestane | Number of Participants With Adverse Drug Reaction for Subjects With Renal Dysfunction | Gamma-glutamyltransferase abnormal | 1 participants |
Secondary
Number of Participants With Unexpected Adverse Drug Reaction
Adverse drug reaction that is not included in the precautions for useor undesirable effects section in the package insert (same as Local Product Document).
Time frame: 24 weeks
Population: Safety analysis population included all enrolled subjects who had received at least 1 confirmed, administration of exemestane.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane | Number of Participants With Unexpected Adverse Drug Reaction | Gastritis | 2 participants |
| Exemestane | Number of Participants With Unexpected Adverse Drug Reaction | Hyperlipidaemia | 1 participants |
| Exemestane | Number of Participants With Unexpected Adverse Drug Reaction | Angina pectoris | 1 participants |
| Exemestane | Number of Participants With Unexpected Adverse Drug Reaction | Asthenia | 1 participants |
| Exemestane | Number of Participants With Unexpected Adverse Drug Reaction | Dyspepsia | 1 participants |
| Exemestane | Number of Participants With Unexpected Adverse Drug Reaction | Abdominal discomfort | 1 participants |
| Exemestane | Number of Participants With Unexpected Adverse Drug Reaction | Constipation | 1 participants |
| Exemestane | Number of Participants With Unexpected Adverse Drug Reaction | Hiatus hernia | 1 participants |
| Exemestane | Number of Participants With Unexpected Adverse Drug Reaction | Erythema | 1 participants |
| Exemestane | Number of Participants With Unexpected Adverse Drug Reaction | Urticaria | 1 participants |