Evaluation of cabazitaxel in patients with brain metastasis secondary to breast cancer and non-small-cell lung cancer

• Conditions: MedDRA version: 16.0Level: LLTClassification code 10006128Term: Brain metastasesSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 16.0Level: PTClassification code 10059282Term: Metastases to central nervous systemSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]; Brain metastasis secondary to HER2-negative breast cancer and NSCLC, not previously irradiated and not requiring immediate radiation.

• Registration Number: EUCTR2012-005194-32-BE
• Lead Sponsor: Institut Jules Bordet

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-06-05
• Last Update Posted: 17 August 2015

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

- Signed informed consent
- Age>18, ECOG 0-1
- Histologically confirmed 1) HER2-negative invasive breast carcinoma or 2) NSCLC
- In patients with breast cancer, HER2-negative status by FISH or immunohistochemistry (score 0, or +1).
- In patients with breast cancer, known estrogen and progesterone receptor status.
- Evidence of measurable disease in the brain (at least 1cm)
- Stable or decreasing dosage of steroids for 7 days prior to baseline MRI.
- No evidence of (cortical) cognitive impairment as defined by a Mini-Mental Status Exam (MMSE)
score = 25/30.
- No more than 4 prior lines of systemic chemotherapy in the metastatic setting
- Adequate hematopoietic function defined as:
•Hemoglobin = 9.0g/dL
•Absolute neutrophilic count = 1.5 x 109L
•Platelet count = 100 x 109L
- Adequate hepatic function defined as:
•AST = 2.5 x upper limit of normal (ULN)
•ALT = 2.5 x ULN
•Total bilirubin = 1.0 x ULN
- Adequate renal function defined as serum creatinine = 1.5 x ULN. If creatinine ranges from 1.0 – 1.5 x ULN, creatinine clearance determined by CKD-EPI formula should be calculated and only patients with clearance >60 mL/min are eligible
- Adequate contraceptive method in patients with child-bearing potential.
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 37
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- History of prior whole brain irradiation
- Progressive neurological symptoms requiring immediate brain irradiation
- Pregnancy or lactation
- History of hypersensitivity reaction to taxanes
- History of hypersensitivity to polysorbate 80 containing agents
- Current or planned treatment with strong inhibitors or inducers of cytochrome P450.
- Less than 3 weeks since the last treatment of chemotherapy, biological therapy, and/or
immunotherapy
- Leptomeningeal carcinomatosis
- Contra-indication to contrast-enhanced MRI

Study & Design

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