Education and Training
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.
Stanford Investigator(s):
Intervention(s):
- drug: paclitaxel
- drug: LCL161
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