A randomized, phase 2, neoadjuvant study of weekly paclitaxel withLCL161 in patients with triple negative breast cancer

• Conditions: Triple negative breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2012-000677-23-BE
• Lead Sponsor: ovartis Pharma Services AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-12-17
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 200

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified