NCT01275859已完成2 期
Neoadjuvant Letrozole and Lapatinib in Postmenopausal Women With ER and Her2 Positive Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- pCR
研究概览
简要总结
Cross-talk between epidermal growth factors and the ER occurs at multiple levels and seems to play a crucial role in breast cancer progression and endocrine resistance.Combined HER1/HER2-targeted therapy with aromatase inhibitors for ER-positive and HER-2 positive postmenopausal breast cancer might enhance response and block emergence of endocrine resistant tumor.
详细描述
- To evaluate the efficacy of the neoadjuvant combination therapy with letrozole and lapatinib in postmenopausal patients with ER-positive and HER2-positive breast cancer.
- To assess markers predictive of treatment response and outcome in this setting.
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
- •Written informed consent
- •Female patients
- •Histologically confirmed invasive breast cancer
- •Primary tumor greater than 2cm diameter, measured by sonography
- •N0-3 (any N if resectable) and no evidence of distant metastasis (M) (isolated supraclavicular node involvement allowed)
- •ER positive (intermediate and strong positive)
- •HER2 positive (IHC3+ or FISH positive in case of IHC 2+)
- •No evidence of metastasis (M0)
- •No prior hormonal, chemotherapy or radiotherapy is allowed
- •No breast operation other than biopsy to make diagnosis is allowed
- •Postmenopausal women with ECOG Performance Status of 0 or 1
- •Postmenopausal, as defined by any of the following:
- •At least 55 years of age
- •Under 55 years of age and amenorrheic for at least 12 months OR follicle-stimulating hormone (FSH) values ≥ 30 IU/L and estradiol levels ≤ 20 IU/L
- •Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at least 6 months
- •Adequate hematopoietic, renal, hepatic function:
排除标准
- •Patients who received hormonal, chemotherapy or radiotherapy for breast cancer
- •Patients who underwent surgery for breast cancer
- •Patients with bilateral invasive breast cancer
- •Patients with inflammatory breast cancer (T4d)
- •Patients without primary tumor (T0) Inability to perform [18F]FES PET imaging due to physical inability, claustrophobia, or other mental illness.
- •ER poor disease as defined locally (e.g: Allred score 1-3, H-score<100)
- •Patients who have history of cancer other than in situ uterine cervix cancer or non-melanotic skin cancer
- •Chronic daily treatment with aspirin (>325mg/day) or clopidogrel (>75mg/day)
- •Chronic daily treatment with corticosteroids (dose of >10mg /day ethylprednisolone equivalent)
- •Clinically significant cardiovascular disease: CVA/stroke (<6month prior to enroll), MI (<6month prior to enroll), unstable angina, NYHA Grade II or greater congestive heart failure, or serious cardiac arrhythmia requiring medication.
- •Hormone replacement therapy within 4 weeks of starting treatment
- •Known hypersensitivity to any of the study drugs including ditosylate monohydrate salt
- •Pregnant or nursing mother (if applicable)
研究组 & 干预措施
Letrozole, Lapatinib
Experimental
Letrozole 2.5mg po qd + Lapatinib 1500mg po qd for 18-21 wks
干预措施: Letrozole, Lapatinib (Drug)
结局指标
主要结局
pCR
时间窗: 2010 Nov- 2012 May
To evaluate the pathologic complete response (pCR) rate to lapatinib combined with letrozole in neoadjuvant setting
次要结局
- SUV for [18F]FES PET(2010 Nov- 2012 May)
研究者
Sung-Bae Kim
Professor
Asan Medical Center
研究点 (1)
Loading locations...
相似试验
终止
2 期
Neoadjuvant Study of Palbociclib in Combination With Letrozole and Trastuzumab in Stage II-III ER+ HER2+ Breast CancerCancer of BreastBreast CarcinomaBreast CancerNCT02907918Washington University School of Medicine26
进行中（未招募）
1 期
Epidermal growth factor enemas versus mesalazine enemas for the treatment of mild-to-moderate active left-sided ulcerative colitis or proctitis - EGF enema in UCEUCTR2006-002036-25-GBniversity Hospitals of Leicester NHS Trust50
已完成
2 期
Neoadjuvant Endocrine Therapy in Breast CancerHighly Endocrine Responsive Operable Breast CancerNCT03397537Guangdong Provincial People's Hospital46
撤回
2 期
The Role of Erlotinib an Epidermal Growth Factor Receptor (EGFR) Inhibitor in the Treatment of Myelodysplastic SyndromeMyelodysplastic SyndromeNCT00570375University of Cincinnati
已完成
2 期
Erlotinib in Treating Patients With Locally Advanced or Metastatic Breast CancerBreast CancerNCT00030537National Cancer Institute (NCI)