Neoadjuvant Endocrine Therapy in Locally Advanced Hormone Receptor Positive Breast Cancer in a Low-Resource, Middle-Income Setting (Guatemala)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 35
- 主要终点
- Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Tamoxifen
Tamoxifen 20mg by mouth daily
干预措施: Tamoxifen (Drug)
结局指标
主要结局
Number of Participants Who Were Successfully Accrued in the Study, as a Measure of Feasibility
时间窗: 4-6 months
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.
次要结局
- Breast Conserving Therapy(4-6 months)
- Number of Participants With Definitive Surgery in Responders to Neoadjuvant Tamoxifen(4-6 months)
- Pathologic Complete Response(4-6 months)
- Ki67 Suppression Rate at 4-6 Weeks in Patients Who Underwent an On-treatment Biopsy(4-6 weeks)
- Overall Clinical Response Rate(4-6 months)
研究者
Laila Saied
Clinical Fellow
Vanderbilt University