Conditions: Breast Cancer Breast Neoplasms
Keywords: Breast neoplasms Breast cancer Locally advanced breast cancer Neoadjuvant endocrine therapy Tamoxifen Low and middle income country
Allocation: NA | Intervention model: SINGLE_GROUP
Enrollment: 35
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Tamoxifen 20mg by mouth daily

Interventions: intervention 1: Tamoxifen
Intervention descriptions: intervention 1: Tamoxifen 20mg by mouth daily

Protocol document: