A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer

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