A Randomized, Phase 2, Neoadjuvant Study of Weekly Paclitaxel With or Without LCL161 in Patients With Triple Negative Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms; Triple Negative Breast Neoplasms
Intervention: LCL161; paclitaxel
Intervention description: LCL161 was available as 300 mg, tablets, which was supplied in child-resistant bottles.; Commercially available paclitaxel was sourced locally by each study site. Generic paclitaxel could be used for study treatment.
iv 80mg/m2
Intervention MeSH terms: Paclitaxel
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 209.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Breast cancer,; LCL161,; paclitaxel,; neoadjuvant,; triple negative breast cancer

Summary:

      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
    

Eligibility criteria:

        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