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

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

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

Key facts

Study ID

NCT01617668

Run by

Novartis Pharmaceuticals

People needed

209

Starts

2012-08-01

Expected to finish

2014-09-01

Last updated by the study team

2016-10-17

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Highlands Oncology Group Dept of Highlands Oncology Grp — Fayetteville, Arkansas, United States
• Cedars Sinai Medical Center SC — Los Angeles, California, United States
• University of California at Los Angeles UCLA SC — Los Angeles, California, United States
• Stanford University Medical Center Stanford — Stanford, California, United States
• Yale University School of Medicine Yale Univ — New Haven, Connecticut, United States
• H. Lee Moffitt Cancer Center & Research Institute H. Lee Moffitt SC — Tampa, Florida, United States
• Massachusetts General Hospital Mass General 2 — Boston, Massachusetts, United States
• Memorial Sloan Kettering Cancer Center Dept Onc — New York, New York, United States
• Ohio State Comprehensive Cancer Center/James Cancer Hospital Ohio State — Columbus, Ohio, United States
• Vanderbilt University Medical Center Vanderbilt - Thompson Ln — Nashville, Tennessee, United States
• Baylor College of Medicine Dept of Oncology — Houston, Texas, United States
• Cancer Therapy & Research Center / UT Health Science Center InstituteForDrugDevelopment(5) — San Antonio, Texas, United States
• University of Wisconsin / Paul P. Carbone Comp Cancer Center Univ Wisc 2 — Madison, Wisconsin, United States
• Novartis Investigative Site — Nedlands, Western Australia, Australia
• Novartis Investigative Site — Itajaí, Santa Catarina, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — São Paulo, São Paulo, Brazil
• Novartis Investigative Site — Brno, Czechia
• Novartis Investigative Site — Olomouc, Czechia
• Novartis Investigative Site — Berlin, Germany
• Novartis Investigative Site — Düsseldorf, Germany
• Novartis Investigative Site — Erlangen, Germany
• Novartis Investigative Site — Essen, Germany
• Novartis Investigative Site — Frankfurt, Germany
• Novartis Investigative Site — Freiburg im Breisgau, Germany

Full record on ClinicalTrials.gov

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