NCT02806544

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 35 (actual)
• Sponsor: Vanderbilt University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Breast Cancer
• Breast Neoplasms

Interventions

Type	Name	Description
DRUG	Tamoxifen	Tamoxifen 20mg by mouth daily

Timeline

• Start date: 2013-01-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2016-06-20
• Last updated: 2017-01-30
• Results posted: 2016-11-17