Breast Neoplasms
Conditions
Keywords
An Observational Study of Indian Breast Cancer Patients Receiving Adjuvant Therapy with Aromasin, Antineoplastic Hormonal Drugs, Aromasin
Brief summary
To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India. * Efficacy of the treatment with Aromasin® * Safety of the treatment with Aromasin®
Detailed description
NA The study was prematurely discontinued due to slow enrollment and keeping in mind the observational nature of the study. The decision to terminate had been taken on 16th June 2012 and the LSLV occured on 14th September, 2012. It should be noted that safety concerns have not been seen in this study and have not factored into this decision.
Interventions
OTHERAromasin
Non-Interventional study design.
Sponsors
Pfizer
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.
Exclusion criteria
* Patients presenting with in situ cancers, recurrent or metastatic breast cancer, or a 2nd primary will not be included. * Patients with a known hypersensitivity to Exemestane or its metabolites will also not be included.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer | Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5) | Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes. |
| Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer | Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5) | — |
| Number of Participants Who Died | Baseline until death (up to Year 3.5) | — |
| Number of Participants Who Discontinued Aromasin Therapy | Baseline until discontinuation (up to Year 3.5) | — |
| Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs) | Baseline up to 28 days after last dose of study treatment | An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache. |
| Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42 | Baseline, Month 6, 12, 18, 24, 30, 36, 42 | — |
| Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42 | Baseline, Month 6, 12, 18, 24, 30, 36, 42 | — |
Countries
India
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Exemestane Exemestane (Aromasin) in accordance with local product document (LPD) and dose was adjusted according to medical and therapeutic necessity up to 3.5 years of duration or until tumor relapse occurred. | 39 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Lost to Follow-up | 15 |
| Overall Study | Study Terminated by Sponsor | 1 |
| Overall Study | Withdrawal by Subject | 10 |
Baseline characteristics
| Characteristic | Exemestane |
|---|---|
| Age Continuous | 60.0 years STANDARD_DEVIATION 10.7 |
| Sex: Female, Male Female | 39 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 | 10 / 39 |
| serious Total, serious adverse events | 0 / 39 |
Outcome results
Primary
Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42
Time frame: Baseline, Month 6, 12, 18, 24, 30, 36, 42
Population: Results for this outcome were not reported because change from baseline in BMD could not be calculated as no participant had data available at more than 1 time point.
Primary
Change From Baseline in High Density Lipoprotein-Cholesterol (HDL-C), Low Density Lipoprotein-Cholesterol (LDL-C), Total Cholesterol and Triglycerides at Month 6, 12, 18, 24, 30, 36 and 42
Time frame: Baseline, Month 6, 12, 18, 24, 30, 36, 42
Population: Results for this outcome were not reported because change from baseline in HDL-C, LDL-C, total cholesterol and triglycerides could not be calculated as no participant had data available at more than 1 time point.
Primary
Number of Participants Who Died
Time frame: Baseline until death (up to Year 3.5)
Population: FAS included all enrolled participants who received at least 1 dose of aromasin therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exemestane | Number of Participants Who Died | 0 participants |
Primary
Number of Participants Who Discontinued Aromasin Therapy
Time frame: Baseline until discontinuation (up to Year 3.5)
Population: FAS included all enrolled participants who received at least 1 dose of aromasin therapy.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Exemestane | Number of Participants Who Discontinued Aromasin Therapy | 26 participants |
Primary
Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer
Time frame: Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5)
Population: FAS included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane | Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer | Second primary or contralateral breast cancer | 0 participants |
| Exemestane | Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer | Missing/No response | 1 participants |
Primary
Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs)
An AE was any untoward medical occurrence in participant who received study drug without regard to possibility of causal relationship. Number of participants with AEs related to gynecological, cardiac, venous thromboembolic, musculoskeletal and menopausal symptoms were reported. Gynecological AEs: bleeding, discharge, uterine dilatation and curettage; cardiac AEs: myocardial infarction, hypertension; musculoskeletal: joint stiffness, arthralgia, muscle cramps, fractures; menopausal symptoms: hot flushes, anxiety, depression, headache.
Time frame: Baseline up to 28 days after last dose of study treatment
Population: FAS included all enrolled participants who received at least 1 dose of aromasin therapy.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane | Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs) | Gynecological AEs | 0 participants |
| Exemestane | Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs) | Cardiac AEs | 0 participants |
| Exemestane | Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs) | Venous thromboembolic events | 0 participants |
| Exemestane | Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs) | Musculoskeletal AEs | 0 participants |
| Exemestane | Number of Participants With Gynecological, Cardiac, Thromboembolic, Musculoskeletal and Menopausal Adverse Events (AEs) | Menopausal symptoms | 2 participants |
Primary
Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer
Locoregional recurrence was defined as any recurrence of the breast cancer in the ipsilateral breast, chest wall or axillary lymph nodes.
Time frame: Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5)
Population: Full analysis set (FAS) included all enrolled participants who received at least 1 dose of aromasin therapy. 'N' (number of participants analyzed) signifies those participants who were evaluable for this outcome measure.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Exemestane | Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer | Locoregional/Distant Recurrence | 0 participants |
| Exemestane | Number of Participants With Locoregional/Distant Recurrence of Primary Breast Cancer | Missing/No response | 1 participants |