NCT01709370Unknown2 期
Phase II Neoadjuvant Study of Letrozole in Combination With PD0332991 (Oral CDK 4/6 Inhibitor) for ER Positive, HER2 Negative Breast Cancer in Postmenopausal Women
Organisation for Oncology and Translational Research1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2012年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 45
- 试验地点
- 1
- 主要终点
- Objective response rates
研究概览
简要总结
This is a phase II study evaluating the efficacy and safety of the pre-operative use of letrozole plus PD 0332991 (combination therapy)
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
- •Postmenopausal women
- •Primary tumor greater than 2 cm in diameter
- •Histologically proven invasive breast cancer
- •Positive estrogen receptor
- •Negative HER-2 receptor
- •ECOG performance status ≤ 1 or Karnofsky performance status ≥ 70%
- •Laboratory values must be follows:
- •Absolute neutrophil count ≥ 1,500/mm3; Platelets ≥ 100,000/mm3; Hemoglobin ≥ 9 g/dL; Bilirubin ≤ 1.5 × institutional upper limit of normal (ULN); Serum Creatinine ≤ 1.5 × ULN; Alkaline phosphatase ≤ 2 × ULN; AST and ALT ≤ 2 × ULN; Normal finding of ECG - QTc ≤ 470 msec (based on the mean value of the triplicate ECGs); Left ventricular ejection fraction (LVEF) ≥ 60%.
- •Able to give written informed consent form
- •Able to follow prescription instructions reasonably well
排除标准
- •Severe psychiatric disorder
- •Prior history of other malignancy within 5 years of study entry, aside from basal cell carcinoma or the skin or carcinoma-in-situ of the uterine cervix
- •Locally advanced breast cancer (T3N1 or Any T4 or Any N2, N3), or distant metastasis
- •Multifocal or multicentric breast cancer except that the largest lesion is greater than 2cm
- •Major surgery within 3 weeks of first study treatment
- •Current use or anticipated need for:
- •Food or drugs that are known strong CYP3A4 inhibitors; drugs that are known strong CYP3A4 inducers
- •Severe cardiovascular diseases in the previous 6 months
- •Active inflammatory bowel disease or chronic diarrhea
- •Renal Impairment
- •Poor adrenal function
- •Hepatitis B and/or hepatitis C carriers (unless with normal hepatic function)
- •Known human immunodeficiency virus infection
- •Known hypersensitivity to anti-aromatase drugs or any cell cycle inhibitor
- •Other severe acute or chronic medical or psychiatric condition, or laboratory abnormality that would impart, in the judgment of the investigator, excess risk associated with study participation or study drug administration, or which, in the judgment of the investigator, would make the patient inappropriate for entry into this study
研究组 & 干预措施
Letrozole plus PD 0332991
Experimental
Drug: Letrozole 2.5mg/d for 16 weeks before surgery plus PD 0332991 (CDK-4/6 inhibitor) 125 mg/d for 3 out of 4 weeks in repeated cycles for 16 weeks before surgery
干预措施: Letrozole, PD 0332991 (Drug)
结局指标
主要结局
Objective response rates
时间窗: Every 4 weeks before surgery
次要结局
- Number of Participants with Adverse Events(Continuous during the study, up to 28 days after the last treatment)
研究者
研究点 (1)
Loading locations...
相似试验
终止
2 期
Randomized Phase II Study of Preoperative Letrozole (Femara) in Combination With Avastin in Hormone Receptor Positive Breast CancerHormone-Sensitive Breast CancerBreast CancerNCT00461773Yale University5
已完成
1 期
Combination of Letrozole, Everolimus and TRC105 in Postmenopausal Women With Hormone-Receptor Positive and Her2 Negative Breast CancerBreast CancerNCT02520063University of Alabama at Birmingham15
已完成
4 期
Treatment of Locally Advanced Breast Cancer With Letrozole in Postmenopausal WomenLocally Advanced Breast CancerNCT00237133Novartis Pharmaceuticals112
已完成
2 期
Phase II study of Neoadjuvant Letrozole for Postmenopausal Women with Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-06)Postmenopausal, hormone-receptor positive and primary breast cancerJPRN-UMIN000001325Japan Breast Cancer Research Group (JBCRG)
已完成
2 期
Phase II study of Neoadjuvant Letrozole and Docetaxel for Postmenopausal, Endocrine-responsive and Anthracycline non-responsive Breast Cancer (JBCRG-05)JPRN-UMIN000001214Japan Breast Cancer Research Group (JBCRG)3