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)

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.

Study Overview

• Status: Completed
• Conditions: Breast Cancer; Breast Neoplasms
• Intervention / Treatment: Drug: Tamoxifen

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.

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tamoxifen; Tamoxifen 20mg by mouth daily	Drug: Tamoxifen; Tamoxifen 20mg by mouth daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility	Feasibility is defined as the ability to recruit the stated number of patients and fifty percent of participants completing the trial. Completing the trial is defined as reaching surgery if they are a responder to tamoxifen or obtaining the six week biopsy specimen if they are a non-responder.	4-6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen	Rate of definitive surgery after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be "responders" to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy)	4-6 months
Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy	Result is the number of participants who had Ki67 suppression (< or = 10%) after 4-6 weeks of neoadjuvant tamoxifen out of patients who underwent an on-treatment biopsy.	4-6 weeks
Overall Clinical Response Rate	Clinical response rate was assessed by palpation after 4 months of tamoxifen. Complete response was defined as no palpable primary tumor on clinical examination and lymph nodes < 10 mm. Partial response was defined as at least 30% decrease in the sum of the diameters compared to baseline sum of diameters. The overall clinical response was the sum of the complete clinical response and partial clinical response.	4-6 months
Pathologic Complete Response	Pathologic complete response was defined as no residual tumor at the primary site or the axillary lymph nodes at the time of surgery.	4-6 months
Breast Conserving Therapy	The rate of breast conservation surgery (as opposed to mastectomy) after 4 months of neoadjuvant tamoxifen therapy in patients who were deemed to be "responders" to neoadjuvant tamoxifen (Ki67 < or = 10% after 4-6 weeks on neoadjuvant tamoxifen therapy).	4-6 months

Collaborators and Investigators

• Sponsor: Vanderbilt University
• Collaborators: Washington University School of Medicine; Instituto National de Cancerologia, Guatemala
• Investigators: Principal Investigator: Laila Agrawal, MD, Vanderbilt University

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: June 16, 2016
• First Submitted That Met QC Criteria: June 16, 2016
• First Posted (Estimate): June 20, 2016

Study Record Updates

• Last Update Posted (Estimate): January 30, 2017
• Last Update Submitted That Met QC Criteria: December 1, 2016
• Last Verified: December 1, 2016

More Information

Terms related to this study

• Keywords: Tamoxifen; Breast cancer; Locally advanced breast cancer; Breast neoplasms; Neoadjuvant endocrine therapy; Low and middle income country
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Hormone Antagonists; Bone Density Conservation Agents; Estrogen Antagonists; Selective Estrogen Receptor Modulators; Estrogen Receptor Modulators; Tamoxifen
• Other Study ID Numbers: 150045

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO