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| Name | Class |
|---|---|
| Washington University School of Medicine | OTHER |
| Instituto National de Cancerologia, Guatemala | UNKNOWN |
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This study evaluates the feasibility and efficacy of neoadjuvant tamoxifen for patients with locally advanced hormone receptor positive breast cancer in a low/middle income country.
This is a single arm feasibility study of neoadjuvant tamoxifen for locally advanced hormone receptor positive breast cancer in a low-resource setting in a middle-income country (Guatemala). Patients will be treated with tamoxifen for four to six weeks, then have an on-treatment biopsy to assess Ki-67. If Ki-67 is less than or equal to 10%, the patient will continue on tamoxifen for a total of 4 months; if Ki-67 is greater than 10% or there is clinical progression, patients will be taken off study. The study will evaluate the proportion of patients treated with four months of tamoxifen who undergo definitive surgery and the clinical and pathologic response rates.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tamoxifen | Experimental | Tamoxifen 20mg by mouth daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tamoxifen | Drug | Tamoxifen 20mg by mouth daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility | Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder. | 4-6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen | Rate of definitive surgery after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be "responders" to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy) | 4-6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Laila Agrawal, MD | Vanderbilt University | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Tamoxifen | Tamoxifen 20mg by mouth daily Tamoxifen: Tamoxifen 20mg by mouth daily |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tamoxifen | Tamoxifen 20mg by mouth daily Tamoxifen: Tamoxifen 20mg by mouth daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility | Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder. | The number of patients analyzed was the accrual goal for number of participants and the outcome measure was the actual number of participants accrued. The outcome measure time frame is the maximum time each participant would be on study. | Posted | Number | participants | 4-6 months |
|
4 weeks - 6 months (time on tamoxifen prior to surgery)
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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 | Tamoxifen 20mg by mouth daily Tamoxifen: Tamoxifen 20mg by mouth daily |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Laila Agrawal | Vanderbilt University | 615-322-4967 | laila.saied@vanderbilt.edu |
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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 |
|---|---|
| D013629 | Tamoxifen |
| ID | Term |
|---|---|
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
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| Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy |
Result is the number of participants who had Ki67 suppression (< or = 10%) after 4-6 weeks of neoadjuvant tamoxifen out of patients who underwent an on-treatment biopsy. |
| 4-6 weeks |
| Overall Clinical Response Rate | Clinical response rate was assessed by palpation after 4 months of tamoxifen. Complete response was defined as no palpable primary tumor on clinical examination and lymph nodes < 10 mm. Partial response was defined as at least 30% decrease in the sum of the diameters compared to baseline sum of diameters. The overall clinical response was the sum of the complete clinical response and partial clinical response. | 4-6 months |
| Pathologic Complete Response | Pathologic complete response was defined as no residual tumor at the primary site or the axillary lymph nodes at the time of surgery. | 4-6 months |
| Breast Conserving Therapy | The rate of breast conservation surgery (as opposed to mastectomy) after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be "responders" to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy). | 4-6 months |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Gender | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
| Secondary | Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen | Rate of definitive surgery after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be "responders" to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy) | Posted | Number | participants | 4-6 months |
|
|
|
| Secondary | Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy | Result is the number of participants who had Ki67 suppression (< or = 10%) after 4-6 weeks of neoadjuvant tamoxifen out of patients who underwent an on-treatment biopsy. | 32 of the 35 patients underwent an on-treatment biopsy; 3 patients did not follow-up and were not included in the number of participants analyzed for this measure. | Posted | Number | participants | 4-6 weeks |
|
|
|
| Secondary | Overall Clinical Response Rate | Clinical response rate was assessed by palpation after 4 months of tamoxifen. Complete response was defined as no palpable primary tumor on clinical examination and lymph nodes < 10 mm. Partial response was defined as at least 30% decrease in the sum of the diameters compared to baseline sum of diameters. The overall clinical response was the sum of the complete clinical response and partial clinical response. | This Outcome Measure was only assessed among patients undergoing surgery and is a unique outcome measure. | Posted | Number | participants | 4-6 months |
|
|
|
| Secondary | Pathologic Complete Response | Pathologic complete response was defined as no residual tumor at the primary site or the axillary lymph nodes at the time of surgery. | This Outcome Measure was only assessed among patients who had undergone surgery. | Posted | Number | participants | 4-6 months |
|
|
|
| Secondary | Breast Conserving Therapy | The rate of breast conservation surgery (as opposed to mastectomy) after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be "responders" to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy). | This outcome measure was analyzed in patients who were treated with 4 months of neoadjuvant tamoxifen | Posted | Number | participants | 4-6 months |
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|
|
| 0 |
| 35 |
| 0 |
| 35 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| D006844 |
| Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |