Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| R01CA140245-01 | U.S. NIH Grant/Contract | View source | |
| NCI-2010-01976 | Registry Identifier | NCI CTRP |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| St. Jude Children's Research Hospital | OTHER |
| University Health Network, Toronto | OTHER |
| University of Michigan |
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Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen citrate may fight breast cancer by blocking the use of estrogen by the tumor cells
This phase IIb trial studies how well low-dose tamoxifen citrate works in reducing breast cancer risk in radiation-induced cancer survivors.
PRIMARY OBJECTIVES:
I. To determine the impact of a two-year course of low-dose tamoxifen (tamoxifen citrate) administered at 5 mg per day on surrogate endpoint biomarkers of breast cancer (BC) risk, including: mammographic breast density (MBD), an established radiographic biomarker of BC risk; cytomorphology and proliferative index, tissue biomarkers closely linked to BC risk; and sex steroid hormones and insulin growth factors, circulating biomarkers of BC risk.
II. To establish safety and tolerability of this low-dose tamoxifen regimen, assessing both objective measures (lipid profiles, clotting factors and bone metabolism markers) and patient-reported outcomes.
III. To examine the modifying effect of demographic, clinical, and molecular characteristics on the risk: benefit ratio from this two-year low dose tamoxifen intervention.
IV. To explore the relationship between this low-dose tamoxifen regimen and clinical measures of efficacy (new breast cancer and ductal carcinoma in situ [DCIS] diagnoses) and toxicity (thromboembolic events, reports of hot flashes and gynecological symptoms, liver function abnormalities, and other cancer diagnoses).
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive tamoxifen citrate orally (PO) once daily for 24 months in the absence of disease progression or unacceptable toxicity.
ARM II: Patients receive placebo PO once daily for 24 months in the absence of disease progression or unacceptable toxicity.
After completion of study treatment, patients are followed up periodically for up to 10 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (tamoxifen citrate) | Experimental | Patients receive tamoxifen citrate PO QD for 24 months in the absence of disease progression or unacceptable toxicity. |
|
| Arm II (placebo) | Placebo Comparator | Patients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen Citrate | Drug | 5 mg PO Daily |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Mammographic Breast Density | Mammographic density was quantified as percentage of fibroglandular tissue. Using an intention-to-treat analysis, mammographic breast density (MBD) was compared between patients in the low dose tamoxifen intervention and placebo group by applying the linear mixed effects model for normally distributed data. | At year two post treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin Growth Factor Levels (IGF1) | IGF1 will be treated as a continuous measure. The linear mixed effects model for between group comparisons of measures from 3 time points will be applied. The unstructured mean model and linear in time model will be employed. | Up to 2 years |
| Number of Grade 2-4 Toxicities |
Not provided
Inclusion Criteria:
Exposure to radiation therapy (RT) delivered to the chest, axilla, and/or supraclavicular areas at a cumulative dose of 12 Gy or more by age 40 years; in addition, patients who received total body irradiation by age 40 may be considered
No evidence of active disease from their primary cancer for at least 2 continuous years prior to registration; the indication for RT is not specified but cannot be for primary breast cancer; common examples include, but are not limited to: lymphoma, leukemia, sarcoma, and Wilms tumor occurring in pediatric patients, and lymphoma, leukemia, and sarcoma occurring in young adults; primary cancer therapy must have been completed at least 6 months prior to registration
Well-defined menopausal status falling into one of the following categories:
Exclusion Criteria:
Subsequent malignant neoplasm (SMN) other than those listed below diagnosed within 2 years of study entry; patients with the listed indolent or pre-invasive neoplasms may be eligible if diagnosed within 2 years and all treatment was completed at least 6 months prior to registration:
For women with a prior history of DCIS or breast IEN, only one breast could have been involved and all therapy must have been completed at least 6 months prior to registration; in addition women with a prior history of invasive breast cancer may also be eligible, as long as only one breast was involved, they were diagnosed at least 2 years prior to study entry, and therapy was completed at least 6 months prior to study entry
Bilateral breast implants or status-post bilateral prophylactic mastectomy
Evidence of malignant breast disease on any form of breast imaging; the study only requires annual mammography; however, annual breast magnetic resonance imaging (MRI) is considered standard of care in this patient population (per Children's Oncology Group [COG] or National Comprehensive Cancer Network [NCCN] follow-up guidelines), and breast ultrasound may be indicated if a palpable lesion is detected on screening clinical breast exam; abnormal imaging may require additional radiographs and/or breast biopsy; patients who are found to have benign breast disease with or without atypia may continue on study as long as there is no evidence of malignancy; if there is evidence of malignancy, and only one breast is involved, they may be reapproached 6 months after completion of therapy for consideration of the trial
Baseline categorical mammographic density scored as BIRAD 1, or extremely fatty, in both breasts; if the patient has a prior history of IEN (DCIS, LCIS, or atypical hyperplasia), the contralateral breast must not have a mammographic density score of BIRAD 1; this determination will be made at the local site
Current or recent use (within 6 months of registration or baseline mammogram, whichever is first) of any of the following: systemic hormone replacement therapy (includes oral or transdermal formulations); Vagifem and Estring, two formulations of locally applied vaginal estrogen associated with minimal systemic absorption, may be allowed; other estrogen-containing vaginal creams, while not an exclusion, should be avoided whenever possible; patients with a history of hormone modifying herbal supplements are eligible, but patients will be asked to avoid their use after on study
Current or recent use (within 6 months of registration or baseline mammogram, whichever is first) of any of the following: hormonal forms of contraception (includes oral, transdermal, implanted, and injectable formulations): selective estrogen receptor modifiers; aromatase inhibitors; GnRH analogs; androgens or antiandrogens
Concurrent use of warfarin and strong inhibitors or CYP2D6 will not be allowed
A personal history or a strong family of thromboembolism, including deep venous thrombosis (DVT), pulmonary embolus (PE), or cerebrovascular accident (CVA); a personal history of transient ischemic attack (TIA) or retinal vein thrombosis will also not be allowed; in addition, patients with a condition known to increase hypercoagulability, such as Factor V Leiden disease, will be excluded; patients with atrial fibrillation will be excluded, due to risk of CVA, but patients with coronary artery disease or congestive heart failure without atrial fibrillation will be allowed to participate
Current intrauterine pregnancy or plans to become pregnant within two years; in addition, currently nursing mothers will be excluded
Serum creatinine > 2X the institutional norm
Total bilirubin > 2X the institutional norm
Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamic pyruvic transaminase (SGPT) > 2X the institutional norm
Unable to provide consent
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| Name | Affiliation | Role |
|---|---|---|
| Smita Bhatia, MD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States | ||
| City of Hope Medical Center |
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Participants were screened for eligibility at each participating institution.However, after central review of mammograms, 11 participants were ineligible for the study (mammographic density <25%) and 1 participant was randomized but withdrew before taking the study drug. These 12 participants were excluded from the analysis.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Arm I (Tamoxifen Citrate) | Patients receive tamoxifen citrate PO QD for 24 months in the absence of disease progression or unacceptable toxicity. Tamoxifen Citrate: 5 mg PO Daily Digital mammography: Correlative studies immunohistochemistry staining method: Correlative Studies pharmacological study: Correlative Studies laboratory biomarker analysis: Correlative Studies protein expression analysis: correlative studies pharmacogenomic studies: correlative studies questionnaire administration: Ancillary studies Fine needle aspiration Quality of Life Assessment: Ancillary Studies |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 26, 2015 |
Not provided
| OTHER |
| Dana-Farber Cancer Institute | OTHER |
| Mayo Clinic | OTHER |
| University of Washington | OTHER |
| City of Hope National Medical Center | OTHER |
| M.D. Anderson Cancer Center | OTHER |
| University of Chicago | OTHER |
| University of Minnesota | OTHER |
| University of Colorado, Denver | OTHER |
| Wake Forest University | OTHER |
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 1 tablet daily |
|
| Digital mammography | Procedure | Correlative studies |
|
| immunohistochemistry staining method | Other | Correlative Studies |
|
| pharmacological study | Other | Correlative Studies |
|
| laboratory biomarker analysis | Other | Correlative Studies |
|
| protein expression analysis | Genetic | correlative studies |
|
| pharmacogenomic studies | Other | correlative studies |
|
| questionnaire administration | Other | Ancillary studies |
|
| Fine needle aspiration | Procedure |
|
|
| Quality of Life Assessment | Other | Ancillary Studies |
|
Will be tabulated by treatment arm. Differences by treatment arm will be evaluated using Fisher exact tests. |
| Up to 2 years |
| Biomarker Levels | Total cholesterol, low and high density lipoprotein, triglycerides, and anti-thrombin III enzymatic assay measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time. | Up to 2 years |
| Percentage of Pills Taken Out of the Total Prescribed | The number of pills taken out of the total prescribed in a 3-month period will be modeled as a random effects binomial regression model. The binomial rates from 8 time points (month 3-24) will be modeled as unstructured mean model with 7 indicator variables as well as polynomial models over time. The random-intercept and the random intercept and slope models will be considered. The significance of the time indicators or parameters by treatment interaction will be evaluated for treatment difference in compliance. | Up to 2 years |
| Number of Participants With Different Patient Reported Symptoms, Measured by Questionnaire | The outcomes will be scored as a 5-point Likert-type scale (0-4) in response to questions on how much the patients are bothered by certain symptoms. The questionnaire will be administered every 6 months. The responses will be treated as normally distributed, as ordinal or dichotomized variable, and the linear mixed effects of general linear mixed model (GLMM) methods will be applied to compare changes between treatment groups. Piecewise models will also be fitted with join point at 6 months, considering linear and curvilinear trajectories between 6 and 24 month time points. | Up to 2 years |
| Insulin Growth Factor Levels (IGF3 ) | IGF3 will be treated as a continuous measure. The linear mixed effects model for between group comparisons of measures from 3 time points will be applied. The unstructured mean model and linear in time model will be employed. | Up to 2 years |
| Biomarker Levels - Alkaline Phosphatase | Serum bone-specific alkaline phosphatase measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time. | Up to 2 years |
| Biomarker Levels - Urine N-telopeptide | Urine n-telopeptide measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time. | Up to 2 years |
| Duarte |
| California |
| 91010 |
| United States |
| University of Colorado, Anschutz Medical Campus | Aurora | Colorado | 80045 | United States |
| University of Chicago | Chicago | Illinois | 60637 | United States |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 02115 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109-5718 | United States |
| University of Minnesota | Minneapolis | Minnesota | 55455 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Wake Forest University | Winston-Salem | North Carolina | 27157 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
| MD Anderson | Houston | Texas | 77030 | United States |
| Seattle Cancer Care Alliance | Seattle | Washington | 98109 | United States |
| University Health Network, Toronto | Toronto | Ontario | M5G 2M9 | Canada |
| FG001 | Arm II (Placebo) | Patients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity. Placebo: 1 tablet daily Digital mammography: Correlative studies immunohistochemistry staining method: Correlative Studies pharmacological study: Correlative Studies laboratory biomarker analysis: Correlative Studies protein expression analysis: correlative studies pharmacogenomic studies: correlative studies questionnaire administration: Ancillary studies Fine needle aspiration Quality of Life Assessment: Ancillary Studies |
| Year one post treatment |
|
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Arm I (Tamoxifen Citrate) | Patients receive tamoxifen citrate PO QD for 24 months in the absence of disease progression or unacceptable toxicity. Tamoxifen Citrate: 5 mg PO Daily Digital mammography: Correlative studies immunohistochemistry staining method: Correlative Studies pharmacological study: Correlative Studies laboratory biomarker analysis: Correlative Studies protein expression analysis: correlative studies pharmacogenomic studies: correlative studies questionnaire administration: Ancillary studies Fine needle aspiration Quality of Life Assessment: Ancillary Studies |
| BG001 | Arm II (Placebo) | Patients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity. Placebo: 1 tablet daily Digital mammography: Correlative studies immunohistochemistry staining method: Correlative Studies pharmacological study: Correlative Studies laboratory biomarker analysis: Correlative Studies protein expression analysis: correlative studies pharmacogenomic studies: correlative studies questionnaire administration: Ancillary studies Fine needle aspiration Quality of Life Assessment: Ancillary Studies |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Inter-Quartile Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| 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 | Mammographic Breast Density | Mammographic density was quantified as percentage of fibroglandular tissue. Using an intention-to-treat analysis, mammographic breast density (MBD) was compared between patients in the low dose tamoxifen intervention and placebo group by applying the linear mixed effects model for normally distributed data. | Posted | Least Squares Mean | Standard Error | percentage of fibrogladular tissue | At year two post treatment |
|
|
|
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Insulin Growth Factor Levels (IGF1) | IGF1 will be treated as a continuous measure. The linear mixed effects model for between group comparisons of measures from 3 time points will be applied. The unstructured mean model and linear in time model will be employed. | Posted | Least Squares Mean | Standard Error | ng/mL | Up to 2 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Grade 2-4 Toxicities | Will be tabulated by treatment arm. Differences by treatment arm will be evaluated using Fisher exact tests. | Posted | Number | Adverse Events | Up to 2 years |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Biomarker Levels | Total cholesterol, low and high density lipoprotein, triglycerides, and anti-thrombin III enzymatic assay measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time. | Posted | Least Squares Mean | Standard Error | mg/dL | Up to 2 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Percentage of Pills Taken Out of the Total Prescribed | The number of pills taken out of the total prescribed in a 3-month period will be modeled as a random effects binomial regression model. The binomial rates from 8 time points (month 3-24) will be modeled as unstructured mean model with 7 indicator variables as well as polynomial models over time. The random-intercept and the random intercept and slope models will be considered. The significance of the time indicators or parameters by treatment interaction will be evaluated for treatment difference in compliance. | Posted | Median | Full Range | percentage of pills taken | Up to 2 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Different Patient Reported Symptoms, Measured by Questionnaire | The outcomes will be scored as a 5-point Likert-type scale (0-4) in response to questions on how much the patients are bothered by certain symptoms. The questionnaire will be administered every 6 months. The responses will be treated as normally distributed, as ordinal or dichotomized variable, and the linear mixed effects of general linear mixed model (GLMM) methods will be applied to compare changes between treatment groups. Piecewise models will also be fitted with join point at 6 months, considering linear and curvilinear trajectories between 6 and 24 month time points. | Symptoms with >10% prevalence are reported; patients were dichotomized into 2 groups: those that rated the symptom as moderately or extremely bothersome vs. slightly or quite a bit bothersome | Posted | Number | participants | Up to 2 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Insulin Growth Factor Levels (IGF3 ) | IGF3 will be treated as a continuous measure. The linear mixed effects model for between group comparisons of measures from 3 time points will be applied. The unstructured mean model and linear in time model will be employed. | Posted | Least Squares Mean | Standard Error | ng/mL | Up to 2 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Biomarker Levels - Alkaline Phosphatase | Serum bone-specific alkaline phosphatase measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time. | Posted | Least Squares Mean | Standard Error | ug/L | Up to 2 years |
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Biomarker Levels - Urine N-telopeptide | Urine n-telopeptide measurements will be treated as continuous variables. Transformed to normality as appropriate, the linear mixed effects model will be applied, using the unstructured mean model and linear in time model to assess the effects of low-dose tamoxifen on these measurements over time. | Posted | Least Squares Mean | Standard Error | nM Bone Collagen Equiv. / nM Creatinine | Up to 2 years |
|
Adverse events were collected every six months while the participants were on the two year study.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I (Tamoxifen Citrate) | Patients receive tamoxifen citrate PO QD for 24 months in the absence of disease progression or unacceptable toxicity. Tamoxifen Citrate: 5 mg PO Daily Digital mammography: Correlative studies immunohistochemistry staining method: Correlative Studies pharmacological study: Correlative Studies laboratory biomarker analysis: Correlative Studies protein expression analysis: correlative studies pharmacogenomic studies: correlative studies questionnaire administration: Ancillary studies Fine needle aspiration Quality of Life Assessment: Ancillary Studies | 0 | 34 | 2 | 34 | 26 | 34 |
| EG001 | Arm II (Placebo) | Patients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity. Placebo: 1 tablet daily Digital mammography: Correlative studies immunohistochemistry staining method: Correlative Studies pharmacological study: Correlative Studies laboratory biomarker analysis: Correlative Studies protein expression analysis: correlative studies pharmacogenomic studies: correlative studies questionnaire administration: Ancillary studies Fine needle aspiration Quality of Life Assessment: Ancillary Studies | 0 | 38 | 3 | 38 | 25 | 38 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Myocardial infarction | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (Unspecified) | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hot flashes | Vascular disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Weight loss | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Weight gain | Investigations | MedDRA (Unspecified) | Systematic Assessment |
| |
| Psychiatric disorders - Other | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment | Mood swings, Unhappy with body appearance |
|
| Depression | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Irregular menstruation | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Endrocrine disorders - Other | Endocrine disorders | MedDRA (Unspecified) | Systematic Assessment | Night sweats |
|
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Breast pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Reproductive system and breast disorders-Other | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment | Vaginal dryness, vaginal spotting, genital itching/irritation |
|
| Gastrointestinal disorders - other | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment | Increased appetite, decreased appetite |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Irritability | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vaginal Hemorrhage | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Blurred vision | Eye disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary frequency | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Vaginal discharge | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Restlessness | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Gastroesophageal reflux disease | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Urinary incontinence | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Bloating | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Palpitations | Cardiac disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| General disorders - Other | General disorders | MedDRA (Unspecified) | Systematic Assessment | Fluid retention, intolerance of cold, intolerance of heat |
|
| Fatigue | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Nervous system disorders - Other | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment | Easily distracted, clumsiness |
|
| Bruising | Injury, poisoning and procedural complications | MedDRA (Unspecified) | Systematic Assessment |
| |
| Concentration impairment | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Rash acneiform | Skin and subcutaneous tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspnea | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Paraesthesia | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Memory impairment | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Flatulence | Gastrointestinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Generalized muscle weakness | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Cystitis noninfective | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Tremor | Nervous system disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Upper respiratory infection | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Agitation | Psychiatric disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Dyspareunia | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
| |
| Renal and urinary disorders - Other | Renal and urinary disorders | MedDRA (Unspecified) | Systematic Assessment | burning upon urination; strong urine smell |
|
| Musculoskeletal and connective tissue disorder - Other | Musculoskeletal and connective tissue disorders | MedDRA (Unspecified) | Systematic Assessment | Leg cramps |
|
| Pelvic pain | Reproductive system and breast disorders | MedDRA (Unspecified) | Systematic Assessment |
|
Slower than expected accrual, and financial constraints of supporting the study drug costs necessitated study closure before attainment of planned study enrollment.
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Smita Bhatia | University of Alabama at Birmingham | (205) 638-2120 | sbhatia@peds.uab.edu |
| Dec 10, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013629 | Tamoxifen |
| D007150 | Immunohistochemistry |
| D000071185 | Pharmacogenomic Testing |
| D044963 | Biopsy, Fine-Needle |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D006651 | Histocytochemistry |
| D003584 | Cytological Techniques |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D006652 | Histological Techniques |
| D008919 | Investigative Techniques |
| D007158 | Immunologic Techniques |
| D005820 | Genetic Testing |
| D005821 | Genetic Techniques |
| D033142 | Genetic Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D003954 | Diagnostic Services |
| D011314 | Preventive Health Services |
| D001707 | Biopsy, Needle |
| D001706 | Biopsy |
| D003581 | Cytodiagnosis |
| D013048 | Specimen Handling |
| D003949 | Diagnostic Techniques, Surgical |
| D013514 | Surgical Procedures, Operative |
| D011677 | Punctures |
Not provided
Not provided
| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
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| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| United States |
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| Participants |
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Patients receive placebo PO QD for 24 months in the absence of disease progression or unacceptable toxicity. Placebo: 1 tablet daily Digital mammography: Correlative studies immunohistochemistry staining method: Correlative Studies pharmacological study: Correlative Studies laboratory biomarker analysis: Correlative Studies protein expression analysis: correlative studies pharmacogenomic studies: correlative studies questionnaire administration: Ancillary studies Fine needle aspiration Quality of Life Assessment: Ancillary Studies |
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