NL-OMON39893
Not Yet Recruiting
Phase 2
Clinical and pharmacological feasibility study with 2B3-101 in patients with breast cancer and leptomeningeal metastases - N12LMB: Clinical study with 2B3-101 in patients with breast cancer and LM
Antoni van Leeuwenhoek Ziekenhuis0 sites6 target enrollmentTBD
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- leptomeningeal metastases from breast cancer
- Sponsor
- Antoni van Leeuwenhoek Ziekenhuis
- Enrollment
- 6
- Status
- Not Yet Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Age \>\= 18 years.
- •2\. Radiological or cytological evidence of clinically symptomatic leptomeningeal metastases of pathologically confirmed breast cancer.
- •3\. Concomitant brain metastases are allowed
- •4\. ECOG Performance Status \<\= 2\.
- •5\. Estimated life expectancy of at least 8 weeks.
- •6\. Stable or decreasing dosage of steroids (e.g.dexamethason) for 7 days prior to baseline MRI 7\. Use of non\-enzyme inducing anti\-epileptic drugs is allowed
- •8\. Toxicities incurred as a result of previous anticancer therapy (radiation therapy, chemotherapy, or surgery) must be resolved to \<\= grade 2 (as defined by CTCAE version 4\.0\).
- •9\. Written informed consent according to local guidelines.
- •10\. Local radiation of CNS symptomatic sites more than four weeks prior to start of the study is allowed.
- •11\. Previous trastuzumab treatment will be allowed to continue without
Exclusion Criteria
- •Candidates will be excluded from study entry if any of the following exclusion criteria exist:
- •Prior Treatment:
- •1\. Less than 1 week since the last treatment of lapatinib, dabrafenib, everolimus, capecitabine, anastrazole, letrozole and exemestane; less than 2 weeks since the last treatment of vemurafenib; less than 4 weeks from the last treatment of trametinib, chemotherapy, biological therapy, immunotherapy and systemic radiotherapy (except palliative radiation delivered to \<20% of bone marrow); less than 6 weeks for nitrosoureas and mitomycin C Previous trastuzumab treatment will be allowed to continue without interruption in patients with HER2\+ breast
- •2\. Radiotherapy of the brain or spinal cord/cauda equine or symptomatic bone metastases is allowed before or during 2B3\-101 treatment both as single agent and in combination with trastuzumab but radiated localizations will not be used for response evaluation.
- •3\. Patients that have received a maximum cumulative dose of free (i.e., non\-liposomal) or liposomal doxorubicin \> 360mg/m2 or free epirubicin \> 600mg/m2
- •4\. Current or recent (less than 4 weeks before first 2B3\-101 treatment) treatment with another investigational drug.
- •5\. Any other current anticancer therapy
- •Haematology, coagulation and biochemistry:
- •6\. Inadequate bone marrow function, defined as: Absolute Neutrophil Count (ANC): \< 1\.5 x 109/L, or platelet count \< 100 x 109/L or haemoglobin \< 6 mmol/L.
- •7\. Inadequate liver function, defined as:
Outcomes
Primary Outcomes
Not specified
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