Clinical trial NCT02806544: 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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Breast Neoplasms
Keywords: Breast neoplasms
Breast cancer
Locally advanced breast cancer
Neoadjuvant endocrine therapy
Tamoxifen
Low and middle income country
Lead sponsor: Vanderbilt University
Sponsor class: OTHER
Collaborators: name: Washington University School of Medicine
name: Instituto National de Cancerologia, Guatemala
First posted: 2016-06-20
Enrollment: 35
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility 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

Primary outcomes:
measure: Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility
timeFrame: 4-6 months
Secondary outcomes:
measure: Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen
timeFrame: 4-6 months
measure: Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy
timeFrame: 4-6 weeks
measure: Overall Clinical Response Rate
timeFrame: 4-6 months
measure: Pathologic Complete Response
timeFrame: 4-6 months
measure: Breast Conserving Therapy
timeFrame: 4-6 months
Other outcomes:
Locations:
Study officials:
affiliation: Vanderbilt University
name: Laila Agrawal, MD
role: PRINCIPAL_INVESTIGATOR
References: