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

• Status: Completed
• Trial end date: 2014-09-01
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Vanderbilt University
• Collaborators: Instituto National de Cancerologia, Guatemala; Washington University School of Medicine
• Treatments: Tamoxifen

Criteria

Inclusion Criteria:

• Patient evaluated and treated at INCAN

• Patients must provide informed consent

• Patient must be ≥ 18 years of age.

• Life expectancy ≥ 6 months

• Clinical locally advance breast cancer (Stage IIB or III)

• Pathologically confirmed diagnosis of estrogen receptor (ER)-positive or progesterone receptor (PR)-positive breast cancer with ER or PR Allred Score > 4

• Patient must have an ECOG Performance Status of 0-2

• Patients must be able to swallow and retain oral medication

Exclusion Criteria:

• Patient must not have received any prior chemotherapy, radiation therapy, or biologic therapy for invasive breast cancer within the past five years

• Patient must not be pregnant or nursing

• Patient must not have had any prior malignancy except for adequately treated basal cell (or squamous cell) skin cancer, in situ cervical cancer or other cancer for which the patient has been disease-free for five years.

• Women of childbearing age unable or unwilling to use contraception