EUCTR2012-000677-23-BEActive, not recruitingNot Applicable
A Phase II, multi-center, open-label, neoadjuvant, randomized study of weekly paclitaxel with or without LCL161 in patients with triple negative breast cancer - NA
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 200
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
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 50 mm diameter measured by imaging.
- •- Regional nodes NO-N2
- •- Absence of distant metastatic disease.
- •- ECOG performance status 0-1.
- •- Adequate bone marrow function.
- •- Adequate liver function and serum transaminases.
- •- Adequate renal function.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 160
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
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 (more than 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 at least 180 days after
- •study treatment.
- •- Other protocol-defined inclusion/exclusion criteria may apply.
Investigators
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