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


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.
Allison W. Kurian, M.D., M.Sc.

Professor of Medicine (Oncology) and of Epidemiology and Population Health


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


drug: paclitaxel

drug: LCL161

Not Recruiting

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305

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