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A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer
Not Recruiting
Trial ID: NCT01617668
Purpose
To assess whether adding LCL161 to weekly paclitaxel enhances the efficacy of paclitaxel in
women with triple negative breast cancer whose tumors are positive for a defined pattern of
gene expression
Official Title
A Phase II Multi-center, Open-label, Neoadjuvant, Randomized Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer
Stanford Investigator(s)
Mark Pegram
Susy Yuan-Huey Hung Professor
Allison W. Kurian, M.D., M.Sc.
Professor of Medicine (Oncology) and of Epidemiology and Population Health
Eligibility
Inclusion Criteria:
- 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 (previous Amendment #3 was tumor size greater than 10 mm)
- Regional nodes N0-N2
- Absence of distant metastatic disease
- ECOG performance status 0-1
- Adequate bone marrow function
- Adequate liver function and serum transaminases
- Adequate renal function
Exclusion Criteria:
- 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 (>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 180 days after study treatment
- Other protocol-defined inclusion/exclusion criteria may apply
Intervention(s):
drug: paclitaxel
drug: LCL161
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
CCTO
650-498-7061