A Phase II, multi-center, open-label, neoadjuvant, randomized study ofweekly paclitaxel with or without LCL161 in patients with triple negativebreast cancer - NA

ovartis farmacéutica S.A.0 个研究点目标入组 100 人开始时间: 2012年6月22日最近更新: 2015年2月2日

试验速览

暂无简介。

•- Histologically confirmed diagnosis of invasive triple negative breast cancer.
•- Tumor must be positive for the LCL161 predictive gene expression profile as determined during molecular pre-screening.
•- Candidates for mastectomy or breast-conserving surgery.
•- Primary tumor of greater than 20 mm and less than 50 mm diameter measured by imaging.
•- 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 75
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 25

•- Multicentric invasive tumors; bilateral or inflammatory breast cancer, 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 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 90 days after study treatment.
•- Other protocol-defined inclusion/exclusion criteria may apply.

发起方

ovartis farmacéutica S.A.