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See termination reason in detailed description.
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To generate the following data from patients with early breast cancer treated with Aromasin® in the adjuvant setting in India.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromasin | Other | Non-Interventional study design. |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5) |
| 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) | 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. | Baseline up to 28 days after last dose of study treatment |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with early breast cancer receiving adjuvant therapy with Aromasin® will be eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pfizer Investigational Site | Bangalore | Karnataka | 560 029 | India | ||
| Pfizer Investigational Site |
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| Label | URL |
|---|---|
| To obtain contact information for a study center near you, click here. | View source |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean |
| 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 | 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. | 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. | Posted | Number | participants | Baseline until locoregional/distant recurrence of primary breast cancer (up to Year 3.5) |
|
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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 (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. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal distension | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
Study was terminated due to slow enrollment and observational nature of the study. Low number of participants enrolled was not sufficient to conduct the planned analysis. Study was not terminated due to safety concerns.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@pfizer.com |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C056516 | exemestane |
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| 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 |
| Ludhiana |
| Punjab |
| 141 004 |
| India |
| Pfizer Investigational Site | Ludhiana | Punjab | 141 009 | India |
| Pfizer Investigational Site | Lucknow | Uttar Pradesh | 226 001 | India |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Primary | Number of Participants With Appearance of Second Primary or Contralateral Breast Cancer | 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. | Posted | Number | participants | Baseline until appearance of second primary or contralateral breast cancer (up to Year 3.5) |
|
|
|
| Primary | Number of Participants Who Died | FAS included all enrolled participants who received at least 1 dose of aromasin therapy. | Posted | Number | participants | Baseline until death (up to Year 3.5) |
|
|
|
| Primary | Number of Participants Who Discontinued Aromasin Therapy | FAS included all enrolled participants who received at least 1 dose of aromasin therapy. | Posted | Number | participants | Baseline until discontinuation (up to Year 3.5) |
|
|
|
| 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. | FAS included all enrolled participants who received at least 1 dose of aromasin therapy. | Posted | Number | participants | Baseline up to 28 days after last dose of study treatment |
|
|
|
| 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 | 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. | Posted | Baseline, Month 6, 12, 18, 24, 30, 36, 42 |
|
|
| Primary | Change From Baseline in Bone Mineral Density (BMD) at Month 6, 12, 18, 24, 30, 36 and 42 | 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. | Posted | Baseline, Month 6, 12, 18, 24, 30, 36, 42 |
|
|
| 0 |
| 39 |
| 10 |
| 39 |
| Gastritis | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oedema | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 15.1 | Non-systematic Assessment |
|
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Convulsion | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Breast pain | Reproductive system and breast disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Erythema | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Pruritus allergic | Skin and subcutaneous tissue disorders | MedDRA 15.1 | Non-systematic Assessment |
|
| Lymphoedema | Vascular disorders | MedDRA 15.1 | Non-systematic Assessment |
|
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.
| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|
| Musculoskeletal AEs |
|
| Menopausal symptoms |
|