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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
35
Tamoxifen 20mg by mouth daily
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.
Time frame: 4-6 months
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)
Time frame: 4-6 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 4-6 months
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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).
Time frame: 4-6 months