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| ID | Type | Description | Link |
|---|---|---|---|
| UCSF-H10367-19435-05 | Other Identifier | University of California, San Francisco | |
| NCI-2011-01273 | Registry Identifier | NCI Clinical Trials Reporting Program (CTRP) | |
| CDR0000465205 | Other Identifier | University of California, San Francisco |
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| Name | Class |
|---|---|
| Novartis | INDUSTRY |
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RATIONALE: Estrogen can cause the growth of breast cancer cells. Hormone therapy using tamoxifen or letrozole may fight breast cancer by blocking the use of estrogen by the tumor cells or by lowering the amount of estrogen the body makes.
PURPOSE: This clinical trial is studying how well tamoxifen or letrozole work in treating women with ductal carcinoma in situ.
OBJECTIVES:
OUTLINE: This is a pilot study.
Patients who are premenopausal receive oral tamoxifen once daily for 3 months in the absence of unacceptable toxicity. Patients who are post menopausal receive oral letrozole once daily for 3 months in the absence of unacceptable toxicity.
After 3 months of hormonal therapy, patients undergo lumpectomy or mastectomy.
After completion of study treatment, patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 40 patients will be accrued for this study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tamoxifen or letrozole | Experimental | tamoxifen or letrozole work in treating women with ductal carcinoma in situ |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| letrozole | Drug |
| ||
| tamoxifen citrate |
| Measure | Description | Time Frame |
|---|---|---|
| Median Change in 6-month Tumor Volume Compared to Baseline Using Mammography | Change in size of Ductal Carcinoma in situ (DCIS) for participants on hormonal therapy, as determined by mammography are determined by (1) largest diameter of tumor, as visualized on mammography (2) extent of disease on mammography (3) quantification of mammographically-detected change from baseline to 6-month and used to generate the change in tumor volume of mammographic extent of disease from baseline. Since values were not normally distributed, the median change was calculated, and Wilcoxon sign rank tests were used to evaluate the significance of these changes | Baseline and 6 months |
| Median Change in 6-month Tumor Volume Compared to Baseline Using Magnetic Resonance Imaging (MRI) | Change in size of Ductal Carcinoma in situ (DCIS) on hormonal therapy, as determined by MRI are determined by (1) largest diameter of tumor, as visualized on MRI (2) extent of disease on MRI (3) quantification of MR-detected change from baseline to 6-month and used to generate the change in tumor volume of MRI extent of disease from baseline. Since values were not normally distributed, the median change was calculated, and Wilcoxon sign rank tests were used to evaluate the significance of these changes. | Baseline and 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Responders to Neoadjuvant Therapy at Month 3 | MRI volume response at each time point was classified as follows: 90% image-complete response (ICR90) is defined as a >90% reduction in tumor volume, 80% image-complete response (ICR80) is defined as an 81-90% reduction in tumor volume , partial response (PR) is defined as a 20-80% reduction in tumor volume, and sustained disease or progressive disease (SD/PD) defined as a <20% reduction or increase in volume. |
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DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
Female patient
Premenopausal or postmenopausal
Postmenopausal is defined by any of the following:
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No co-morbidities contraindicating the use of tamoxifen, including any of the following:
No history of contrast dye-related allergies/reactions
No history of metal-containing prostheses or implants
PRIOR CONCURRENT THERAPY:
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| Name | Affiliation | Role |
|---|---|---|
| E. Shelley Hwang, MD, MPH | University of California, San Francisco | Principal Investigator |
| Frederic M. Waldman, MD, PhD | University of California, San Francisco | Principal Investigator |
| Nola M. Hylton, PhD | University of California, San Francisco | Principal Investigator |
| Rita Mukhtar, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, San Francisco | San Francisco | California | 94143 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19689789 | Background | Chen YY, DeVries S, Anderson J, Lessing J, Swain R, Chin K, Shim V, Esserman LJ, Waldman FM, Hwang ES. Pathologic and biologic response to preoperative endocrine therapy in patients with ER-positive ductal carcinoma in situ. BMC Cancer. 2009 Aug 18;9:285. doi: 10.1186/1471-2407-9-285. | |
| Background | Swain RS, Chen YY, Wa C, et al.: Pathologic and biologic response to neoadjuvant anti-estrogen (AE) therapy in patients with ductal carcinoma in situ (DCIS). [Abstract] United States and Canadian Academy of Pathology 95th Annual Meeting, February 11-17, 2006, Atlanta, GA. A-186, 2006. |
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Patients seeking treatment at the University of California, San Francisco (UCSF) Breast Care Center and Kaiser Permanente for a diagnosis of DCIS were approached by their physicians at their discretion, and if fitting the eligibility criteria were asked to participate in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamoxifen or Letrozole | tamoxifen or letrozole work in treating women with ductal carcinoma in situ letrozole tamoxifen citrate conventional surgery neoadjuvant therapy |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline data collected for evaluable patients only
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamoxifen or Letrozole | tamoxifen or letrozole work in treating women with ductal carcinoma in situ letrozole tamoxifen citrate conventional surgery neoadjuvant therapy |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| 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 | Median Change in 6-month Tumor Volume Compared to Baseline Using Mammography | Change in size of Ductal Carcinoma in situ (DCIS) for participants on hormonal therapy, as determined by mammography are determined by (1) largest diameter of tumor, as visualized on mammography (2) extent of disease on mammography (3) quantification of mammographically-detected change from baseline to 6-month and used to generate the change in tumor volume of mammographic extent of disease from baseline. Since values were not normally distributed, the median change was calculated, and Wilcoxon sign rank tests were used to evaluate the significance of these changes | Only 54 patients had evaluable mammograms at 6 months | Posted | Median | Inter-Quartile Range | change in tumor volume (mm) | Baseline and 6 months |
|
Up to 6 months
All good cause efforts to retrieve the serious adverse event and non-serious adverse event data have been exhausted. Adverse event data are no longer accessible per institutional and contractual guidelines for record retention and hence not available to be reported.
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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 | Tamoxifen or Letrozole | tamoxifen or letrozole work in treating women with ductal carcinoma in situ letrozole tamoxifen citrate conventional surgery neoadjuvant therapy |
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All good cause efforts to retrieve the serious adverse event and non-serious adverse event data have been exhausted. Adverse event data are no longer accessible per institutional and contractual guidelines and hence not available to be reported.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. E. Shelly Hwang, MD, MPH | Duke University and Duke Cancer Institute | (919) 684-6849 | shelley.hwang@duke.edu |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D000071960 | Breast Carcinoma In Situ |
| D002285 | Carcinoma, Intraductal, Noninfiltrating |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D000077289 | Letrozole |
| D013629 | Tamoxifen |
| D020360 | Neoadjuvant Therapy |
| ID | Term |
|---|---|
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 |
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|
| conventional surgery | Procedure |
|
| neoadjuvant therapy | Procedure |
|
| 3 months |
| Number of Responders to Neoadjuvant Therapy at Month 6 | MRI volume response at each time point was classified as follows: 90% image-complete response (ICR90) is defined as a >90% reduction in tumor volume, 80% image-complete response (ICR80) is defined as an 81-90% reduction in tumor volume , partial response (PR) is defined as a 20-80% reduction in tumor volume, and sustained disease or progressive disease (SD/PD) defined as a <20% reduction or increase in volume. | 6 months |
| Median Reduction in Tumor Volume by Estrogen Receptor Hormone (ER H-) Quartile Group | Tumor volume changes between baseline and surgery were calculated at month 6 and compared across baseline ER Hormone (H-) Score quartile. The ER H- scores are a percentage that tells you how many cells out of 100 stain positive for hormone receptors. Each participant is assigned an ER H- score at baseline with the full score range between 0 (none have receptors) and 100 (all have receptors). The participants were grouped into quartiles (four equal groups) based on their baseline ER H- score. ER H- score and the reduction in tumor volume from baseline to month 6 was measured for each quartile group. | Baseline and 6 months |
| Median Reduction in Tumor Volume by PgR H-score by Quartile Group | Tumor volume changes between baseline and surgery were calculated at month 6 and compared across baseline PgR Hormone (H-) Score quartile. The PgR H-scores are a percentage that tells you how many cells out of 100 stain positive for hormone receptors. Each participant is assigned a PgR H- score at baseline with the full PgR H score ranges between 0 (none have receptors) and 100 (all have receptors). The participants were grouped into quartiles (four equal groups) based on their baseline PgR H- score and the reduction in tumor volume from baseline to month 6 was measured for each quartile group. A wilcoxon sign rank tests were used to evaluate the significance of these changes | Baseline and 6 months |
| Median Reduction in Tumor Volume by Ki-67 Average Score | Tumor volume changes between baseline and surgery were calculated at month 6 by Baseline Ki-67 Average Score which is divided into 2 groups: (1) <=10% or (2) >10% to 100%. In est results, the Ki-67 findings expressed as a percentage with less than 10% considered low Ki-67 expression and > than 10% or higher considered high. A "high" score means that the breast tumor is more likely to be aggressive and spread quickly. A wilcoxon sign rank tests were used to evaluate the significance of these changes | Baseline and 6 months |
| Correlation Between Pathologic Tumor Size at Radiographic (MRI) Tumor Size | Correlations between pathologic tumor size and maximum diameters of baseline and 6-month MRI extent of disease were evaluated using Spearman correlation coefficient measure of association. The Spearman's rank-order correlation (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. | 6 months |
| Correlation Between Pathologic Tumor Size and Mammographic Tumor Size | Correlations between pathologic tumor size and maximum diameters of baseline and pre-surgical mammographic extent of disease were evaluated using Spearman correlation coefficient measure of association. The Spearman's rank-order correlation (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. | 6 months |
| Baseline MRI not available |
|
| 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 |
|
| Nuclear Grade | The nuclear grade describes how closely the nuclei of cancer cells look like the nuclei of normal breast cells. In general, the higher the nuclear grade, the more abnormal the nuclei are and the more aggressive the tumor cells tend to be. The nuclear grade is also a part of overall tumor grade. | Count of Participants | Participants |
|
| Hormone receptor status | Hormone receptors are proteins, found in and on breast cells, that pick up hormone signals telling the cells to grow. A cancer is called estrogen-receptor-positive (ER+) if it has receptors for estrogen. This suggests that cancer cells may receive signals from estrogen that could promote their growth. The cancer is progesterone-receptor-positive (PgR+) if it has progesterone receptors. This means that cancer cells may receive signals from progesterone that could promote their growth. If the cancer is hormone-receptor-negative (ER- or PgR-) then no receptors are present, | Count of Participants | Participants |
|
|
|
|
| Primary | Median Change in 6-month Tumor Volume Compared to Baseline Using Magnetic Resonance Imaging (MRI) | Change in size of Ductal Carcinoma in situ (DCIS) on hormonal therapy, as determined by MRI are determined by (1) largest diameter of tumor, as visualized on MRI (2) extent of disease on MRI (3) quantification of MR-detected change from baseline to 6-month and used to generate the change in tumor volume of MRI extent of disease from baseline. Since values were not normally distributed, the median change was calculated, and Wilcoxon sign rank tests were used to evaluate the significance of these changes. | Posted | Median | Inter-Quartile Range | change in tumor volume (cm3) | Baseline and 6 months |
|
|
|
|
| Secondary | Number of Responders to Neoadjuvant Therapy at Month 3 | MRI volume response at each time point was classified as follows: 90% image-complete response (ICR90) is defined as a >90% reduction in tumor volume, 80% image-complete response (ICR80) is defined as an 81-90% reduction in tumor volume , partial response (PR) is defined as a 20-80% reduction in tumor volume, and sustained disease or progressive disease (SD/PD) defined as a <20% reduction or increase in volume. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Number of Responders to Neoadjuvant Therapy at Month 6 | MRI volume response at each time point was classified as follows: 90% image-complete response (ICR90) is defined as a >90% reduction in tumor volume, 80% image-complete response (ICR80) is defined as an 81-90% reduction in tumor volume , partial response (PR) is defined as a 20-80% reduction in tumor volume, and sustained disease or progressive disease (SD/PD) defined as a <20% reduction or increase in volume. | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | Median Reduction in Tumor Volume by Estrogen Receptor Hormone (ER H-) Quartile Group | Tumor volume changes between baseline and surgery were calculated at month 6 and compared across baseline ER Hormone (H-) Score quartile. The ER H- scores are a percentage that tells you how many cells out of 100 stain positive for hormone receptors. Each participant is assigned an ER H- score at baseline with the full score range between 0 (none have receptors) and 100 (all have receptors). The participants were grouped into quartiles (four equal groups) based on their baseline ER H- score. ER H- score and the reduction in tumor volume from baseline to month 6 was measured for each quartile group. | Only 46 participants had both evaluable ER scores at baseline and evaluable month 6 scans | Posted | Median | Inter-Quartile Range | decrease in tumor volume (cm^3) | Baseline and 6 months |
|
|
|
|
| Secondary | Median Reduction in Tumor Volume by PgR H-score by Quartile Group | Tumor volume changes between baseline and surgery were calculated at month 6 and compared across baseline PgR Hormone (H-) Score quartile. The PgR H-scores are a percentage that tells you how many cells out of 100 stain positive for hormone receptors. Each participant is assigned a PgR H- score at baseline with the full PgR H score ranges between 0 (none have receptors) and 100 (all have receptors). The participants were grouped into quartiles (four equal groups) based on their baseline PgR H- score and the reduction in tumor volume from baseline to month 6 was measured for each quartile group. A wilcoxon sign rank tests were used to evaluate the significance of these changes | Only 45 participants had both evaluable PgR scores at baseline and evaluable month 6 scans | Posted | Median | Inter-Quartile Range | reduction in tumor volume (cm^3) | Baseline and 6 months |
|
|
|
|
| Secondary | Median Reduction in Tumor Volume by Ki-67 Average Score | Tumor volume changes between baseline and surgery were calculated at month 6 by Baseline Ki-67 Average Score which is divided into 2 groups: (1) <=10% or (2) >10% to 100%. In est results, the Ki-67 findings expressed as a percentage with less than 10% considered low Ki-67 expression and > than 10% or higher considered high. A "high" score means that the breast tumor is more likely to be aggressive and spread quickly. A wilcoxon sign rank tests were used to evaluate the significance of these changes | Only 45 participants had both evaluable Ki-67 scores at baseline and evaluable month 6 scan | Posted | Median | Inter-Quartile Range | reduction in tumor volume (cm^3) | Baseline and 6 months |
|
|
|
|
| Secondary | Correlation Between Pathologic Tumor Size at Radiographic (MRI) Tumor Size | Correlations between pathologic tumor size and maximum diameters of baseline and 6-month MRI extent of disease were evaluated using Spearman correlation coefficient measure of association. The Spearman's rank-order correlation (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. | Posted | Number | Spearman correlation coefficient (rs) | 6 months |
|
|
|
|
| Secondary | Correlation Between Pathologic Tumor Size and Mammographic Tumor Size | Correlations between pathologic tumor size and maximum diameters of baseline and pre-surgical mammographic extent of disease were evaluated using Spearman correlation coefficient measure of association. The Spearman's rank-order correlation (rs) measures the strength and direction of association between two variables. The Spearman correlation coefficient, rs, can take values from +1 to -1 where a value of +1 indicates a perfect association, an rs of 0 indicates no association and an rs of -1 indicates a perfect negative association. The closer rs is to 0, the weaker the association. | Only 54 patients had evaluable mammograms at 6 months | Posted | Number | Spearman correlation coefficient (rs) | 6 months |
|
|
|
|
| 0 |
| 67 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D002278 | Carcinoma in Situ |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D000230 | Adenocarcinoma |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| Title | Measurements |
|---|
|
| SD/PD |
|
| Title | Measurements |
|---|
|
| SD/PD |
|
|
| Baseline ER Score quartile = 51-75 |
|
|
| Baseline ER Score quartile = 76-100 |
|
|
|
| Baseline PgR Score Quartile = 51-75 |
|
|
| Baseline PgR Score Quartile = 76-100 |
|
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|