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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-01603 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| ACCRU-SC-1603 | Other Identifier | Academic and Community Cancer Research United | |
| P30CA015083 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This randomized phase III trial studies how well oxybutynin chloride works in managing hot flashes in patients who are not candidates for, or not interested in hormone replacement therapy. Previous studies have shown that oxybutynin is effective in managing hot flashes, however doses used in prior studies have resulted in side effects. This trial is evaluating lower doses of oxybutynin with the goal of determining if they are efficacious with less side effects.
ADAM-VTE
PRIMARY OBJECTIVES:
I. To determine whether oxybutynin chloride (oxybutynin) can diminish hot-flash activity in women with a history of breast cancer or in women who have a concern about taking estrogen for fear of breast cancer.
SECONDARY OBJECTIVES:
I. To perform a dose-response evaluation of two oxybutynin doses. II. To determine the toxicity of oxybutynin in the study population. III. To assess the impact of hot-flash activity on overall quality of life and to examine whether oxybutynin can diminish this impact on quality of life.
OUTLINE: Patients are randomized into 1 of 4 groups.
GROUP I (LOW-DOSE OXUBUTYNIN CHLORIDE): Patients receive lower dose oxybutynin chloride orally (PO) twice a day (BID) on days 8-49 in the absence of unacceptable toxicity.
GROUP II (LOW-DOSE PLACEBO): Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity.
GROUP III (HIGH-DOSE OXUBUTYNIN CHLORIDE): Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity.
GROUP IV (HIGH-DOSE PLACEBO): Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group I (low-dose oxybutynin chloride) | Experimental | Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity. |
|
| Group II (low-dose placebo) | Placebo Comparator | Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity. |
|
| Group III (high-dose oxybutynin chloride) | Experimental | Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity. |
|
| Group IV (high-dose placebo) | Placebo Comparator | Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Oxybutynin Chloride | Drug | Given PO |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Hot Flash Activity Score From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | Average change in hot flash activity score from baseline to Week 7 for Low Dose Oxybutynin vs Placebo. The hot flash activity will be measured by the weekly average hot flash score (Sloan JA, et. al., 2001), which is a composite entity of both frequency and severity of hot flashes (The Hot Flash Diary collects the following information for Day 1- Day 7 of each week: Number of mild hot flashes, Number of moderate hot flashes, Number of severe hot flashes, Number of very severe hot flashes). This is a count, so it can range from 0 to infinity. | Baseline up to day 49 |
| Measure | Description | Time Frame |
|---|---|---|
| Average Change in Hot Flash Score From Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo | Average change in Hot Flash Score from Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included low dose oxybutynin, weeks 1-7, no current aromatase inhibitor, age group 18-49, no tamoxifen, hot flash symptom duration < 9 months, and 4-9 hot flashes/day as fixed effects, and participant and error as random effects. The mean change in Hot Flash Score from Week 1 to Week 7 is reported below for the low-dose oxybutynin and placebo groups. |
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Inclusion Criteria:
Exclusion Criteria:
Any of the following current (=< 4 weeks prior) or planned therapies:
Prior use of oxybutynin during the period in which patient has had hot flashes
Pregnant women
Nursing women
History of any of the following contraindications to oxybutynin:
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| Name | Affiliation | Role |
|---|---|---|
| Charles Loprinzi | Academic and Community Cancer Research United | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Illinois CancerCare-Peoria | Peoria | Illinois | 61615 | United States | ||
| Carle Cancer Center NCI Community Oncology Research Program |
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| ID | Title | Description |
|---|---|---|
| FG000 | High-dose Oxybutynin Chloride Group | Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity. |
| FG001 | Low-dose Oxybutynin Chloride Group |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| 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 | Sep 8, 2017 |
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| Placebo | Other | Given PO |
|
|
| Quality-of-Life Assessment | Other | Ancillary studies |
|
|
| Questionnaire Administration | Other | Ancillary studies |
|
| Baseline up to day 49 |
| Average Change in Hot Flash Score From Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo | Average change in Hot Flash Score from Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included low dose oxybutynin, weeks 1-7, no current aromatase inhibitor, age group 18-49, no tamoxifen, hot flash symptom duration < 9 months, and 4-9 hot flashes/day as fixed effects, and participant and error as random effects. The mean change in Hot Flash Score from Week 1 to Week 7 is reported below for the high-dose oxybutynin and placebo groups. | Baseline up to day 49 |
| Average Change of Severity of Stomach Pain/Cramps Symptoms as Measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | Average Change of severity of Stomach pain/cramps symptoms as measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo The Symptom Experience Questionnaire stomach pain/cramps item ("Over the past week, have you experienced stomach pain or cramps?") is scored from 0 to 10 with higher values being worse symptoms. So a negative value means the symptom is improving and a positive score means the symptom is getting worse. | Baseline up to day 49 |
| Average Change of Daily Interference (Work) From Baseline to Week 7 as Measured by the Hot Flash-Related Daily Interference Scale (HFRDIS) Comparing Low Dose Oxybutynin vs Placebo and High Dose Oxybutynin vs Placebo | Average Change of daily interference (Work) from baseline to Week 7 as measured by the Hot Flash-Related Daily Interference Scale (HFRDIS) comparing Low dose oxybutynin vs Placebo and High dose oxybutynin vs Placebo. HFRDIS Work item ("Work (work outside the home and housework)") Interference scores run from 0 to 10 with 0 being no interference and 10 being complete interference. | Baseline up to day 49 |
| Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) | The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. | Up to 7 weeks |
| Urbana |
| Illinois |
| 61801 |
| United States |
| Oncology Associates at Mercy Medical Center | Cedar Rapids | Iowa | 52403 | United States |
| Cancer Center of Kansas - Wichita | Wichita | Kansas | 67214 | United States |
| Saint Elizabeth Medical Center South | Edgewood | Kentucky | 41017 | United States |
| Michigan Cancer Research Consortium NCORP | Ann Arbor | Michigan | 48106 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Waverly Hematology Oncology | Cary | North Carolina | 27518 | United States |
| AnMed Health Cancer Center | Anderson | South Carolina | 29621 | United States |
| Rapid City Regional Hospital | Rapid City | South Dakota | 57701 | United States |
| Saint Vincent Hospital -Green Bay | Green Bay | Wisconsin | 54301 | United States |
| University of Wisconsin Hospital and Clinics | Madison | Wisconsin | 53792 | United States |
| Marshfield Clinic | Marshfield | Wisconsin | 54449 | United States |
Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity. |
| FG002 | High-dose Placebo Group | Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity. |
| FG003 | Low-dose Placebo Group | Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity. |
| COMPLETED |
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| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | High-dose Oxybutynin Chloride Group | Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity. |
| BG001 | Low-dose Oxybutynin Chloride Group | Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity. |
| BG002 | High-dose Placebo Group | Patients receive lower dose placebo PO BID on days 8-14 and higher dose placebo on days 15-49 in the absence of unacceptable toxicity. |
| BG003 | Low-dose Placebo Group | Patients receive lower dose placebo PO BID on days 8-49 in the absence of unacceptable toxicity. |
| BG004 | 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 | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| ECOG Performance Status | Eastern Cooperative Oncology Group PS Scale: 0)Fully active, able to carry on all pre-disease performance without restriction; 1)Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work; 2)Ambulatory and capable of all selfcare but unable to carry out any work activities. Up and about more than 50% of waking hours; 3)Capable of only limited selfcare, confined to bed or chair more than 50% of waking hours; 4)Completely disabled. Cannot carry on any selfcare. Totally confined to bed or chair. | Count of Participants | 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 | Average Change in Hot Flash Activity Score From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | Average change in hot flash activity score from baseline to Week 7 for Low Dose Oxybutynin vs Placebo. The hot flash activity will be measured by the weekly average hot flash score (Sloan JA, et. al., 2001), which is a composite entity of both frequency and severity of hot flashes (The Hot Flash Diary collects the following information for Day 1- Day 7 of each week: Number of mild hot flashes, Number of moderate hot flashes, Number of severe hot flashes, Number of very severe hot flashes). This is a count, so it can range from 0 to infinity. | Patients who received high-dose oxybutynin, low-dose oxybutynin or placebo and completed the Hot Flash Diary at baseline and Week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups. | Posted | Mean | Standard Deviation | score on a scale | Baseline up to day 49 |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change in Hot Flash Score From Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo | Average change in Hot Flash Score from Week 1 to Week 7 Comparing Low Dose Oxybutynin to Placebo. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included low dose oxybutynin, weeks 1-7, no current aromatase inhibitor, age group 18-49, no tamoxifen, hot flash symptom duration < 9 months, and 4-9 hot flashes/day as fixed effects, and participant and error as random effects. The mean change in Hot Flash Score from Week 1 to Week 7 is reported below for the low-dose oxybutynin and placebo groups. | Patients who received low-dose oxybutynin or placebo and completed the Hot Flash Diary at baseline and Week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose oxybutynin chloride group. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline up to day 49 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change in Hot Flash Score From Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo | Average change in Hot Flash Score from Week 1 to Week 7 Comparing High Dose Oxybutynin to Placebo. The least squares (LS) mean was estimated from a mixed-effects model with repeated measures (MMRM) that included low dose oxybutynin, weeks 1-7, no current aromatase inhibitor, age group 18-49, no tamoxifen, hot flash symptom duration < 9 months, and 4-9 hot flashes/day as fixed effects, and participant and error as random effects. The mean change in Hot Flash Score from Week 1 to Week 7 is reported below for the high-dose oxybutynin and placebo groups. | Patients who received higher dose oxybutynin or placebo and completed the Hot Flash Diary at baseline and Week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the high-dose oxybutynin chloride group. | Posted | Least Squares Mean | Standard Error | score on a scale | Baseline up to day 49 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change of Severity of Stomach Pain/Cramps Symptoms as Measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo | Average Change of severity of Stomach pain/cramps symptoms as measured by the Symptom Experience Questionnaire From Baseline to Week 7 for Low Dose Oxybutynin vs Placebo and for High Dose Oxybutynin vs Placebo The Symptom Experience Questionnaire stomach pain/cramps item ("Over the past week, have you experienced stomach pain or cramps?") is scored from 0 to 10 with higher values being worse symptoms. So a negative value means the symptom is improving and a positive score means the symptom is getting worse. | Patients who completed baseline and week 7 Symptom Experience Questionnaire Stomach pain/cramps item were included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups. | Posted | Mean | Standard Deviation | change in score on a scale | Baseline up to day 49 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Average Change of Daily Interference (Work) From Baseline to Week 7 as Measured by the Hot Flash-Related Daily Interference Scale (HFRDIS) Comparing Low Dose Oxybutynin vs Placebo and High Dose Oxybutynin vs Placebo | Average Change of daily interference (Work) from baseline to Week 7 as measured by the Hot Flash-Related Daily Interference Scale (HFRDIS) comparing Low dose oxybutynin vs Placebo and High dose oxybutynin vs Placebo. HFRDIS Work item ("Work (work outside the home and housework)") Interference scores run from 0 to 10 with 0 being no interference and 10 being complete interference. | Patients who completed the Hot Flash-Related Daily Interference Scale (HFRDIS) Work item at baseline and week 7 are included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups. | Posted | Mean | Standard Deviation | change in score on a scale | Baseline up to day 49 |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Secondary | Toxicity, Assessed Using National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 4.0 (v4) | The maximum grade for each type of toxicity will be recorded for each patient, and frequency tables will be reviewed to determine toxicity patterns within patient groups. In addition, we will review all adverse event data that is graded as 3, 4, or 5 and classified as either "unrelated" or "unlikely to be related" to study treatment in the event of an actual relationship developing. The overall toxicity rates (percentages) for grade 3 or higher adverse events considered at least possibly related to treatment are reported below. | Patients who received at least one cycle of treatment and were assessed for adverse events were included in this analysis. Low-dose and high-dose placebo groups were combined to serve as a control/placebo group to compare with the low-dose and high-dose oxybutynin chloride groups. | Posted | Count of Participants | Participants | Up to 7 weeks |
|
Adverse events were collected at the end of each cycle for patients randomized to the treatment arm; Up to 7 weeks
All graded AEs are reported for patients who completed at least 1 cycle of tx & AEs were assessed. The high dose and low dose placebo arms are combined for adverse event reporting. Because patients on these two arms are all taking placebo (and nothing else), there is no reason for adverse events to be different on these two placebo arms. This is consistent with the analysis of the primary endpoint, where each Oxybutynin arm was compared with the combined placebo arms.
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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 | High-dose Oxybutynin Chloride Group | Patients receive lower dose oxybutynin chloride PO BID on days 8-14 and higher dose oxybutynin chloride on days 15-49 in the absence of unacceptable toxicity. | 0 | 46 | 2 | 46 | 19 | 46 |
| EG001 | Low-dose Oxybutynin Chloride Group | Patients receive lower dose oxybutynin chloride PO BID on days 8-49 in the absence of unacceptable toxicity. | 0 | 48 | 0 | 48 | 13 | 48 |
| EG002 | Placebo Group | Patients receive placebo regardless of dose level in the absence of unacceptable toxicity. | 0 | 44 | 0 | 44 | 8 | 44 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Dry mouth | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Blurred vision | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Dry eye | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Eye disorders - Other, specify | Eye disorders | MedDRA 12 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Diarrhea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dry mouth | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Dyspepsia | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA 12 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA 12 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA 12 | Systematic Assessment |
| |
| Concentration impairment | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 12 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA 12 | Systematic Assessment |
| |
| Urinary retention | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Urinary tract pain | Renal and urinary disorders | MedDRA 12 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA 12 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 12 | Systematic Assessment |
|
Not provided
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles L. Loprinzi, M.D | Mayo Clinic | 507/284-4565 | loprinzi.charles@mayo.edu |
| Apr 8, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| D019584 | Hot Flashes |
| D000071960 | Breast Carcinoma In Situ |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D002278 | Carcinoma in Situ |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C005419 | oxybutynin |
Not provided
Not provided
Not provided
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| 1 |
|
| Superiority |
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| OG002 | Placebo Group | Patients receive placebo PO BID on days 8-49 in the absence of unacceptable toxicity. |
|
|
|
| OG002 |
| Placebo Group |
Patients receive placebo PO BID on days 8-49 in the absence of unacceptable toxicity. |
|
|
|
| OG002 |
| Placebo Group |
Patients receive placebo PO BID on days 8-49 in the absence of unacceptable toxicity. |
|
|