MPA Revisited: A Phase II Study of Anti-Metastatic, Anti-Angiogenic Therapy in Postmenopausal Patients With Hormone Receptor Negative Breast Cancer. A Translational Breast Cancer Research Consortium (TBCRC) Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 7
- 主要终点
- Clinical Benefit Rate (CR + PR + SD > 6 Months).
研究概览
简要总结
The purpose of this study is to evaluate the impact of MPA alone and in combination with low dose oral chemotherapy in patients with ER- and PR- advanced breast cancer.
详细描述
PRIMARY OBJECTIVES:
I. To determine the clinical benefit rate (complete response [CR] + partial response [PR] + stable disease [SD] >= 6 months) of medroxyprogesterone acetate (MPA) monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer.
SECONDARY OBJECTIVES:
I. To evaluate the toxicity of MPA and MPA + ldoCM in this patient population. II. To explore the relationship between MPA trough level and clinical benefit. III. To explore genetic determinants of MPA bioavailability and trough concentration.
IV. To explore potential surrogates of biologic activity including Nm-23 expression in primary tumor, change in Nm-23 expression in skin, change in plasma thrombospondin (TSP)-1, change in plasma plasminogen activator inhibitor (PAI)-1 antigen and activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically or cytologically confirmed adenocarcinoma of the breast with measurable locally recurrent or metastatic disease
- •Primary tumor must be ER negative and PR negative
- •Patients must be post-menopausal
- •Patients may have had up to 3 prior chemotherapy regimens for recurrent/metastatic disease
- •Adequate organ function as evidenced by laboratory studies outlined in section 3.6 of the protocol
- •Patients with treated, asymptomatic brain metastases are eligible provided chronic steroid therapy is not required
排除标准
- •Patients must not have extensive pleural effusion or ascites
- •Patients must not have history of DVT or pulmonary embolism w/in past 12 mo
- •Patients must not have had chemotherapy or hormonal therapy within 2 weeks of study entry
- •Patients must not have had radiation therapy within 1 week of study entry.
研究组 & 干预措施
Cohort I (MPA)
Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
干预措施: Medroxyprogesterone progesterone acetate (MPA) (Drug)
Cohort II (MPA, low-dose chemotherapy)
Medroxyprogesterone progesterone acetate (MPA) will be administered orally as a single daily dose.
Cyclophosphamide will be administered orally as a single daily dose. Methotrexate will be administered twice daily on days 1 and 2 of each week.
干预措施: Medroxyprogesterone with Cyclophosphamide + Methotrexate (Drug)
结局指标
主要结局
Clinical Benefit Rate (CR + PR + SD > 6 Months).
时间窗: baseline through end of study, up to 3 years
To determine the clinical benefit rate (Complete Response + Partial Response + Stable Disease \> 6 months) per Response Evaluation Criteria in Solid tumors (RECIST version 1.0). of MPA monotherapy and MPA + low dose oral cyclophosphamide and methotrexate (ldoCM) in patients with refractory hormone receptor negative metastatic breast cancer. This will show the percent of patients who had Clinical Benefit and the Exact 95% Confidence Interval.
次要结局
- Grade 3 or 4 Adverse Events Related to Treatment(baseline through end of treatment)
- MPA Trough Level > 50 ng/mL When Have Clinical Benefit(baseline through end of treatment)
- MPA Trough Concentration(Cycle 1 (Day 10-14) and Cycle 2 (Day 1))
研究者
Kathy Miller
Ballvé-Lantero Professor of Medicine
Indiana University