EUCTR2012-000677-23-GB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 - NA
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 200
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
- •- Histologically confirmed diagnosis of invasive triple negative breast cancer.
- •- Known status for the LCL161 predictive gene expression signature as determined during molecular pre-screening.
- •- Candidates for mastectomy or breast-conserving surgery.
- •- Primary tumor of greater than 20 mm and less than or equal to 50 mm
- •diameter measured by imaging.
- •- Regional nodes NO-N2
- •- Absence of distant metastatic disease.
- •- ECOG performance status 0-1.
- •- Adequate bone marrow function.
- •- Adequate liver function and serum transaminases.
- •- Adequate renal function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •- Bilateral or inflammatory breast cancer (bilateral mammography is required during Screening/baseline), locally recurrent breast cancer.
- •- Patients currently receiving systemic therapy for any other malignancy, or having received systemic therapy for a malignancy in the preceding 3 months.
- •- Uncontrolled cardiac disease.
- •- Patients who are currently receiving chronic treatment (more than 3 months) 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.
- •- Impaired GI function that may affect the absorption of LCL161.
- •- Pregnant or breast feeding (lactating) women.
- •- 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 at least 180 days after study treatment.
- •- Other protocol-defined inclusion/exclusion criteria may apply.
研究者
相似试验
进行中（未招募）
不适用
A Phase II study of weekly paclitaxel with or without LCL161 in patients with breast cancerWomen with triple negative breast cancer whose tumors are positive fora defined pattern of gene expressionMedDRA version: 14.1Level: LLTClassification code 10006204Term: Breast carcinomaSystem Organ Class: 100000004864EUCTR2012-000677-23-ITOVARTIS FARMA100
进行中（未招募）
不适用
A randomized, phase 2, neoadjuvant study of weekly paclitaxel with LCL161 in patients with triple negative breast cancerTriple negative breast cancerEUCTR2012-000677-23-DEovartis Pharma Services AG200
进行中（未招募）
不适用
A randomized, phase 2, neoadjuvant study of weekly paclitaxel with LCL161 in patients with triple negative breast cancerTriple negative breast cancerEUCTR2012-000677-23-IEovartis Pharma Services AG200
进行中（未招募）
不适用
A randomized, phase 2, neoadjuvant study of weekly paclitaxel withLCL161 in patients with triple negative breast cancerTriple negative breast cancerEUCTR2012-000677-23-BEovartis Pharma Services AG200
进行中（未招募）
不适用
A Phase II, multi-center, open-label, neoadjuvant, randomized study ofweekly paclitaxel with or without LCL161 in patients with triple negativebreast cancerEUCTR2012-000677-23-ESovartis farmacéutica S.A.100