A randomized, phase 2, neoadjuvant study of weekly paclitaxel with LCL161 in patients with triple negative breast cancer

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

Registration Number: EUCTR2012-000677-23-IE

Lead Sponsor: ovartis Pharma Services AG

Brief Summary: Not available

Detailed Description: Not available

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 or equal to 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.