Spots Global Cancer Trial Database for Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country

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Trial Identification

Brief Title: Neoadjuvant Tamoxifen in Locally Advanced Breast Cancer in a Low/Middle Income Country

Official Title: Neoadjuvant Endocrine Therapy in Locally Advanced Hormone Receptor Positive Breast Cancer in a Low-Resource, Middle-Income Setting (Guatemala)

Study ID: NCT02806544

Conditions

Breast Cancer

Breast Neoplasms

Interventions

Tamoxifen

Study Description

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.