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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02806544
• Other study ID #: 150045
• Status: Completed
• Phase: Phase 2
• First received: June 16, 2016
• Last updated: June 16, 2016
• Start date: January 2013
• Est. completion date: September 2014

Study information

• Verified date: June 2016
• Source: Vanderbilt University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Guatemala: Comité Institucional de Ética del INCAP
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Tamoxifen
Tamoxifen 20mg by mouth daily

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
Vanderbilt University	Instituto National de Cancerologia, Guatemala, Washington University School of Medicine

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients responding to tamoxifen who had definitive surgery	Patients who had Ki67 < or = 10% after 4-6 weeks on treatment with neoadjuvant tamoxifen underwent definitive surgery	4-6 months	No
Secondary	Ki67 suppression response rates		4-6 weeks	No
Secondary	Clinical response rate		4-6 months	No
Secondary	Pathologic response rate		4-6 months	No