Trial Search Results

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

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

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Novartis Pharmaceuticals

Intervention(s):

  • Drug: LCL161
  • Drug: paclitaxel

Phase:

Phase 2

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

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

Female

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting