A RANDOMIZED, PHASE II STUDY OF ENZALUTAMIDE, ENZALUTAMIDE WITH MIFEPRISTONE, and TREATMENT OF PHYSICIAN'S CHOICE IN PATIENTS WITH AR+ METASTATIC TRIPLE-NEGATIVE OR ER-LOW BREAST CANCER
概览
- 阶段
- 2 期
- 干预措施
- Enzalutamide
- 疾病 / 适应症
- Metastatic Breast Cancer
- 发起方
- Memorial Sloan Kettering Cancer Center
- 入组人数
- 201
- 试验地点
- 23
- 主要终点
- progression-free survival (PFS)
- 状态
- 招募中
- 最后更新
- 2个月前
概览
简要总结
The researchers are doing this study to find out if the study drug, enzalutamide, alone or combined with the study drug, mifepristone, is effective in treating advanced or metastatic androgen receptor-positive (AR+) triple negative breast cancer (TNBC) or estrogen receptor-low breast cancer (ER-low BC), and whether these study treatments work as well as standard chemotherapy with carboplatin, paclitaxel, capecitabine, or eribulin.
研究者
入排标准
入选标准
- •Screening Cohort (non-MSK patients only):
- •Age ≥18 years at time of consent
- •signed the pre-screening informed consent document to allow for AR testing as part of study screening
- •Treatment Cohort:
- •Female or male
- •Pathologically confirmed invasive breast cancer that is unresectable, locally advanced, or metastatic
- •TNBC (ER/PgR \<1%) or ER-low defined as:
- •ER and PgR 1-10%
- •HER2 negative per American Society of Clinical Oncology/College of American Pathologists guidelines
- •Local testing for ER/PgR and HER2 is acceptable for eligibility.
排除标准
- •Seizure disorder or any condition that may predispose to seizure (e.g., prior cortical stroke, significant brain trauma) at any time in the past. History of loss of consciousness or transient ischemic attack within 12 months.
- •History of brain metastases or leptomeningeal disease.
- •Prior antiandrogen therapy (AR antagonist or CYP17 inhibitors).
- •Other concurrent investigational anticancer agents.
- •Confirmed QT interval with Fridericia correction (QTcF) \> 480 msec.
- •Any severe concurrent disease, infection, or comorbid condition that renders the patient inappropriate for enrollment in the opinion of the investigator or that interferes with the patient's ability to participate in the study requirements.
- •Pregnant patients are not eligible for study.
- •Women with a history of unexplained vaginal bleeding or with endometrial hyperplasia with atypia or endometrial carcinoma are excluded from study.
- •An active gastrointestinal disorder affecting absorption (e.g., gastrectomy, uncontrolled celiac disease).
- •Use of concurrent or chronic daily corticosteroid use. Topical or inhaled corticosteroids are permitted.
研究组 & 干预措施
Enzalutamide
Enzalutamide 160 mg/day, continuous daily dosing in a 21-day cycle
干预措施: Enzalutamide
Enzalutamide with Mifepristone
Enzalutamide 120mg/day and mifepristone 300mg/day, continuous daily dosing in a 21-day cycle
干预措施: Enzalutamide
Enzalutamide with Mifepristone
Enzalutamide 120mg/day and mifepristone 300mg/day, continuous daily dosing in a 21-day cycle
干预措施: Mifepristone
Chemotherapy:Carboplatin, Paclitaxel, Eribulin or Capecitabine (TPC)
The treating physician must select from one of the following regimens. * Eribulin 1.4 mg/m2 IV Day 1 and Day 8 in a 21-day cycle * Capecitabine 1000-1250 mg/m2 twice daily, orally Day 1-14 in a 21-day cycle * Paclitaxel 80 mg/m2 IV Day 1, Day 8 in a 21-day cycle * Carboplatin AUC 6 IV Day 1 in a 21-day cycle * Carboplatin AUC 2 IV Day 1, Day 8 and Day 15 in a 21-day cycle Patients randomized to TPC may be offered crossover to enzalutamide plus mifepristone treatment at the time of disease progression if they continue to meet eligibility criteria.
干预措施: TPC
结局指标
主要结局
progression-free survival (PFS)
时间窗: 2 years
Response and progression will be evaluated in this study using the international criteria proposed by the revised Response Evaluation Criteria in Solid Tumors (RECIST) Committee (version 1.1).