An Investigator Initiated Registry of Simple Oral Therapy for Low Risk Breast Cancer (SOLR)
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Conversion from oral endocrine therapy for any reason to guideline-directed therapy
研究概览
简要总结
This pilot clinical trial studies how well endocrine therapy works in treating patients with HER2 negative, low risk breast cancer. Estrogen can cause the growth of breast cancer cells. Endocrine therapies such as aromatase inhibitors and selective estrogen receptor modulators may lessen the amount of estrogen made by the body.
详细描述
PRIMARY OBJECTIVES:
I. To estimate the conversion rate from a standard low-toxicity approach to guideline-directed therapy which includes surgery +/- radiation therapy as a result of progression of disease or patient/provider choice.
II. To examine factors that might differ between those who convert from the low-toxicity approach to the guideline-directed therapy and those do not convert.
SECONDARY OBJECTIVES:
I. To measure the safety and clinical effectiveness of systemic endocrine therapy used in a prolonged neoadjuvant fashion.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Able to provide written informed consent
- •A diagnosis of invasive breast cancer, with or without an in situ component, that is:
- •Originally identified by screening mammography
- •Characterized by standard diagnostic mammography +/- breast ultrasound
- •Clinically node negative
- •Confirmed by breast magnetic resonance imaging (MRI) in a facility that maintains active American College of Radiology (ACR) accreditation to be of low clinical stage (=< 2 cm, node negative, unifocal invasive)
- •Estrogen receptor (ER) and progesterone receptor (PR) Allred scored, each > 5/8
- •Her2 negative using American Society of Clinical Oncology (ASCO)-College of American Pathologists (CAP) guidelines
- •ki-67 proliferation scored, < 20%
- •Clinical Nottingham grade 1 or 2
- •Scored on the MammaPrint 70-gene breast cancer recurrence assay as low risk
- •Prior to the discovery of the breast cancer, clinically post-menopausal as defined as: i) one or more years from last menses; or ii) history of oophorectomy; or iii) follicle stimulating hormone (FSH) test result in the post-menopause reference range
- •Willing to accept oral endocrine therapy with a third generation aromatase inhibitor (AI) or selective estrogen receptor modifier (SERM)
- •Willing to undergo routine surveillance with breast ultrasound and/or mammography
排除标准
- •Known contraindication to aromatase inhibitor or SERM therapy
- •Pregnant at time of or within prior year of diagnosis
- •Clinically detected or palpable disease prior to biopsy in either breast or ipsilateral axilla
- •Prior history of invasive breast cancer or ductal breast carcinoma in situ (DCIS)
- •Prior use of aromatase inhibitor therapy apart from assisted reproduction
- •Prior use of SERM
- •Unmanaged/uncontrolled mental health disorder
- •Life expectancy < 6 months (m) for any cause
- •Biopsy confirmed multifocal, multicentric, or contralateral disease that is invasive or non-invasive
- •DCIS with focal invasion
研究组 & 干预措施
Treatment (AI, SERM)
Patients receive exemestane PO QD, anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Anastrozole (Drug)
Treatment (AI, SERM)
Patients receive exemestane PO QD, anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Exemestane (Drug)
Treatment (AI, SERM)
Patients receive exemestane PO QD, anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Laboratory Biomarker Analysis (Other)
Treatment (AI, SERM)
Patients receive exemestane PO QD, anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Letrozole (Drug)
Treatment (AI, SERM)
Patients receive exemestane PO QD, anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Quality-of-Life Assessment (Other)
Treatment (AI, SERM)
Patients receive exemestane PO QD, anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Questionnaire Administration (Other)
Treatment (AI, SERM)
Patients receive exemestane PO QD, anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Tamoxifen Citrate (Drug)
Treatment (AI, SERM)
Patients receive exemestane PO QD, anastrozole PO QD, letrozole PO QD, tamoxifen citrate PO QD, or toremifene citrate PO QD at the discretion of the treating physician. Treatment continues in the absence of disease progression or unacceptable toxicity.
干预措施: Toremifene Citrate (Drug)
结局指标
主要结局
Conversion from oral endocrine therapy for any reason to guideline-directed therapy
时间窗: Up to 5 years
Includes clinical or radiographic progression, patient preference, endocrine therapy intolerance or toxicity, or death from any cause. Descriptive statistics will be summarized among all patients and patients within each of the two groups (stay with oral therapy vs conversion due to any causes).
次要结局
- Advanced imaging (if performed on any subset of patients)(Up to 5 years)
- Effect of comorbidity severity interaction(Up to 5 years)
- Effects emanating from tertiary care(Up to 5 years)
- Effect of age(Up to 5 years)
- Cost-effectiveness and patient-centeredness outcomes defined as financial toxicity and solubility, quality of life (physical, mental, emotional changes) on endocrine therapy, and, access to support services(Up to 5 years)
- Effect of type of endocrine therapy type (selective estrogen receptor modifier versus aromatase inhibitor)(Up to 5 years)
- Progression of disease while on primary endocrine therapy, as measured objectively by routine diagnostic breast imaging (mammography and/or ultrasound)(Up to 5 years)