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See Detailed Description
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Evaluating the safety, tolerability and efficacy of Aromasin® when used in routine clinical practice, evaluating adherence to prescribed Aromasin® treatment and to understand reasons for early discontinuation.
This study was terminated on 01-Aug-2011 due to very low potential to enroll planned number of patients or any sufficient number of patients for complete statistical analyses. This study is not being terminated because of safety or efficacy concerns.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Main Group | Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromasin (exemestane) | Other | Aromasin (exemestane), tablets 25 mg, once a day |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. | Month 0 up to Month 36 or early withdrawal |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Concomitant Morbidities | Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable. | Month 0 up to Month 36 or early withdrawal |
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Inclusion Criteria:
Exclusion Criteria:
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Postmenopausal Women With Invasive, Estrogen Receptor Positive Early Breast Cancer Who Are Disease-Free After 2-3 Years Of Initial Adjuvant Tamoxifen Therapy
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| Name | Affiliation | Role |
|---|---|---|
| Pfizer CT.gov Call Center | Pfizer | Study Director |
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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 | Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 milligram (mg) oral tablet once daily to complete 5 years of adjuvant hormonal therapy. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Exemestane | Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy. |
| 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 Adverse Events (AEs) | An AE was any untoward medical occurrence attributed to study medication in a participant who received study medication. | Safety analysis set included participants who received at least one dose of the study medication during the observation period. | Posted | Number | Participants | Month 0 up to Month 36 or early withdrawal |
|
|
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The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one subject and as nonserious in another subject, or one subject may have experienced both a serious and nonserious event during the study.
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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 | Participants with 2-3 years of initial adjuvant tamoxifen therapy who received exemestane (Aromasin) 25 mg oral tablet once daily to complete 5 years of adjuvant hormonal therapy. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Infections and infestations | MedDRA 14.1 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA 14.1 |
The study was prematurely discontinued, therefore not all data was analyzed and only one outcome measure timeframe was presented.
| 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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| Number of Participants With Concomitant Medications |
Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary. |
| Month 0 up to Month 36 or early withdrawal |
| Percentage of Participants Who Discontinued the Study Medication | Month 0 up to Month 36 or early withdrawal |
| Number of Participants With Reasons for Discontinuation From Study Treatment | Month 0 up to Month 36 or early withdrawal |
| Time to Discontinuation of Study Medication | Month 0 up to Month 36 or early withdrawal |
| Percentage of Participants With Recurrent Disease | Percentage of participants with confirmed recurrent disease at the end of the study (recurrence was defined as loco-regional and/or contralateral and/or distance metastases). | Month 36 or early withdrawal |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Type of Tumor | Number of participants with different types of tumor such as; ductal carcinoma, lobular carcinoma, invasive ductal carcinoma, invasive lobular carcinoma, papillary carcinoma, medullary carcinoma, mucinous (colloid) carcinoma and others. | Number | Participants |
|
| Type of Surgery | Number of participants who had undergone different type of surgeries which included mammectomy, radical resection, radical mastectomy, mastectomy, mammectomy with lymphadenectomy, ovariectomy, mammectomy with lymph node dissection, mastectomy type madden of mammary gland. | Number | Participants |
|
| Hormone Receptor Status | Number of participants with positive or negative estrogen and progesterone receptors. | Number | Participants |
|
| Lymph Node Status | Number | Participants |
|
| Tumor Node Metastasis (TNM) Stage | TNM was based on size of tumor, if cancer cells had spread to nearby lymph nodes (LN), or distant (to other parts of the body) metastasis had occurred. Stages included: stage 0(no evidence of cancer cells), stage 1(T1N0M0), stage IIA(T0N1M0, T1N1M0, T2N0M0), stage IIB(T2N1M0, T3N0M0), stage IIIA(T0N2M0, T1N2M0, T2N3M0, T3N1orN2M0), stage IIIC(any TN3M0), stage IV(anyT anyNM1), where T0=early form of tumor, T1= <2 centimeter(cm), T2=2-5 cm, T3= >2 cm, T4=large sized tumor, N0=not spread to LN, N1=spread to 1 to 3,N2=spread to 4 to 9,N3=spread >10 axillary LN, M0=no metastasis, M1= Metastasis. | Number | Participants |
|
| Histopathological Grade | The grade of a cancer depends on what the cells look like and the growth-rate. Lower grade indicates a slower-growing cancer and a higher grade indicates a faster-growing one. Grade 1 (resemble normal cells, not growing rapidly), grade 2 (grow faster than normal cells), grade 3 and 4 (abnormal cells, grow and spread aggressively). | Number | Participants |
|
| Number of participants on chemotherapy | Number of participants who received chemotherapy. Chemotherapeutic drugs included cyclophosphamide, doxorubicin, 5-fluorouracil, paclitaxel, epirubicin, fluorouracil. | Number | Participants |
|
| Number of participants on radiotherapy | Number of participants who received radiotherapy as measured in radiations per centigray (Rads/cGy). | Number | Participants |
|
| Concomitant morbidities in the past | Participants who had a concomitant morbidity in the past; participants with more than one concomitant co-morbidity were counted for each of the co-morbidity classes applicable. | Number | Participants |
|
| Participants |
|
|
| Secondary | Number of Participants With Concomitant Morbidities | Participants who had a concomitant morbidity during the study for any period of time; participants with more than one concomitant morbidity were counted for each of the concomitant morbidity classes applicable. | Safety analysis set included participants who received at least one dose of the study medication during the observation period. | Posted | Number | Participants | Month 0 up to Month 36 or early withdrawal |
|
|
|
| Secondary | Number of Participants With Concomitant Medications | Concomitant medication (any medication other than, and in addition to, the study medication) taken for any period of time during the study and was coded by World Health Organization (WHO) medical dictionary. | Safety analysis set included participants who received at least one dose of the study medication during the observation period. | Posted | Number | Participants | Month 0 up to Month 36 or early withdrawal |
|
|
|
| Secondary | Percentage of Participants Who Discontinued the Study Medication | Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study. | Posted | Month 0 up to Month 36 or early withdrawal |
|
|
| Secondary | Number of Participants With Reasons for Discontinuation From Study Treatment | Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study. | Posted | Month 0 up to Month 36 or early withdrawal |
|
|
| Secondary | Time to Discontinuation of Study Medication | Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study. | Posted | Month 0 up to Month 36 or early withdrawal |
|
|
| Secondary | Percentage of Participants With Recurrent Disease | Percentage of participants with confirmed recurrent disease at the end of the study (recurrence was defined as loco-regional and/or contralateral and/or distance metastases). | Data was not analyzed as the study was terminated due to insufficient number of participants enrolled in the study. | Posted | Month 36 or early withdrawal |
|
|
| 1 |
| 89 |
| 6 |
| 89 |
| Metastases to bone | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 |
|
| Metastases to spine | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 14.1 |
|
| Migraine | Nervous system disorders | MedDRA 14.1 |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 14.1 |
|
| Hypertension | Vascular disorders | MedDRA 14.1 |
|
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 |
|---|---|
|
| Cholelithiasis |
|
| Diabetes mellitus |
|
| Lipid metabolism disorder |
|
| Osteoporosis |
|
| Reproductive tract disorder |
|
| Hypertension |
|
| Varicose vein |
|
| Title | Measurements |
|---|---|
|
| Calcium D3 "stada" |
|
| Captopril |
|
| Diltiazem |
|
| Durapatite |
|
| Enalapril |
|
| Glibenclamide |
|
| Indapamide |
|
| Inosine |
|
| Levothyroxine sodium |
|
| Loratadine |
|
| Metoprolol tartrate |
|
| Nifedipine |
|
| Penicillin not otherwise specified (NOS) |
|
| Pentaerithrityl tetranitrate |
|
| Suguan |
|
| Tyrosine |
|
| Vinpocetine |
|
| Zoledronic acid |
|