EUCTR2012-000677-23-IT进行中（未招募）不适用
A Phase II, multi-center, open-label, neoadjuvant, randomized study of weekly paclitaxel with or without LCL161 in patients with triple negative breast cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •1. Adult female (=18 years old)
- •2. Histologically confirmed diagnosis of invasive breast cancer, previously untreated (patients who have been treated for cancer of the contralateral breast can be included if there is at least a 2 year interval from last systemic treatment for breast cancer before randomization for this study). Disease must be negative immunohistochemically for estrogen and progesterone receptors (=1% of nuclei positive by IHC) and must not have
- •Her2 overexpression (by Herceptest or validated IHC assay; 0-1+ staining) or in cases of ambiguous Her2 expression (2+ staining), Her2 amplification (by CISH or FISH).
- •3. Positive for the LCL161 predictive gene expression profile as determined during molecular pre-screening
- •4. Candidates for mastectomy or breast-conserving surgery
- •5. Primary tumor of greater than 20 mm and less than 50 mm diameter measured by imaging (American Joint Committee on Cancer (AJCC) TNM stage T2)
- •6. Regional lymph node AJCC TNM stages N0-N2:
- •a. N0: No regional lymph node metastases
- •b. N1: Metastases to movable ipsilateral axillary lymph nodes
- •c. N2: Metastases in ipsilateral axillary nodes that are fixed or matted, or in clinically apparent ipsilateral internal mammary nodes in the absence of axillary node metastases (Clinically apparent is defined as detected by clinical examination, grossly visible disease pathologically, or imaging studies (excluding lymphoscintigraphy))
- •7. Absence of distant metastatic disease (AJCC TNM stage M0)
- •8. ECOG performance status 0-1 (refer to Table 7-2)
- •9. Adequate bone marrow function defined as WBC =3.5 x 109/L, ANC WNL, platelets =LLN, and hemoglobin =10 g/dL
- •10. Adequate liver function defined as total serum bilirubin =1.5X ULN and serum transaminases =2.5X ULN
- •11. Adequate renal function defined as creatinine =1.5X ULN
- •12. Able and willing to give informed consent and comply with the protocol
- •13. Written informed consent obtained prior to any Screening/baseline procedures
- •Are the trial subjects under 18? no
- •Number of subjects for this age range: 0
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 75
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 25
排除标准
- •1. Multicentric invasive tumors (defined as additional foci of tumor outside the breast quadrant containing the primary tumor); bilateral or inflammatory breast cancer (bilateral
- •mammography is required during Screening/baseline); locally recurrent breast cancer
- •2. Patients currently receiving systemic therapy for any other malignancy, or having received
- •systemic therapy for a malignancy in the preceding 3 months
- •3. Any concurrent severe and/or uncontrolled medical conditions that could increase the patient’s risk for toxicity while in the study or that could confound discrimination between
- •disease- and study treatment-related toxicities
- •4. Uncontrolled cardiac disease including:
- •a. History or presence of ventricular tachyarrhythmia
- •b. Unstable atrial fibrillation (ventricular response =100 bpm). Patients with stable atrial
- •fibrillation are eligible provided they do not meet any of the other cardiac exclusion criteria
- •c. Clinically significant resting bradycardia (HR =50 bpm)
- •d. Angina pectoris or acute myocardial infarction = 3 months prior to starting study drug
- •e. Other clinically significant heart disease (e.g., symptomatic congestive heart failure; uncontrolled arrhythmia or hypertension; history of labile hypertension or poor compliance with an antihypertensive regimen)
- •5. Patients who are currently receiving chronic treatment with corticosteroids at a dose = 10 mg of prednisone (or its glucocorticoid equivalent) per day (inhaled and topical steroids
- •are allowed), or any other chronic immunosuppressive treatment that cannot be discontinued prior to starting study drug
- •6. Impaired GI function that may affect the absorption of LCL161
- •7. Patients who are currently receiving treatment with agents that are metabolized solely through CYP3A4/5 and have a narrow therapeutic index or are strong CYP2C8 inhibitors; or are receiving treatment with agents that carry a risk for QT prolongation and are
- •CYP3A substrates (refer to Appendix 3). Caution should be used in patients taking other CYP2C8- or CYP3A4/5-interacting agents.
- •8. Prior hypersensitivity reactions to a taxane or to Cremophor EL (polyoxyethylated castor oil)
- •9. Pregnant or breast feeding (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive ß-
- •HCG laboratory test (> 5 mIU/mL)
- •10. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing and for 90 days after study treatment. Highly effective contraception methods include:
- •Total abstinence or
- •Male partner or female sterilization or
- •Combination of any two of the following (a+b or a+c, or b+c):
- •a. Use of oral, injected or implanted hormonal methods of contraception
- •b. Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- •c. Barrier methods of contraception: condom for male partner or occlusive cap
- •(diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/vaginal
- •suppository
研究者
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