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This study compares weekly paclitaxel given before surgery (neoadjuvant), with or without a drug called LCL161, in people with triple negative breast cancer. It enrolled patients with tumors between 20 and 50 mm, without distant spread, and with a known LCL161 gene expression signature. The study was carried out in Phase 2 and has been completed.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
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Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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