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)

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

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

Mark Pegram

Susy Yuan-Huey Hung Professor


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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