Evaluation of the Efficacy and Safety of Nal-IRI for Progressing Brain Metastases in Breast Cance… (NCT03328884) | Clinical Trial Compass
CompletedPhase 2
Evaluation of the Efficacy and Safety of Nal-IRI for Progressing Brain Metastases in Breast Cancer Patients
Spain55 participantsStarted 2017-05-02
Plain-language summary
Multicenter open-label, phase II trial, to evaluate the efficacy and safety of nal-IRI in patients with HER2-negative breast cancer, who have documented Central Nervous System (CNS) progression following Whole Brain Radio Therapy (WBRT), Stereotactic Radiosurgery (SRS) and/or surgery, as determined by the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Female or male patients \> 18 years
✓. Patients must have a diagnosis of metastatic breast cancer.
✓. Patients should have been pretreated with taxanes at any time prior to the study enrolment if not formally contraindicated.
✓. At least one prior chemotherapy regimen for advanced disease.
✓. Evidence of new brain metastases and/or stable or progressive brain metastases following previous WBRT and/or SRS and/or surgery.
✓. At least one brain lesion needed to be measurable for new and progressive metastases (≥10 mm on T1-weighted, gadolinium-enhanced magnetic resonance imaging). For stable brain metastases at least one extracerebral lesion need to be measurable.
✓. HER2 negative breast cancer defined as 0 - 1+ by immunohistochemistry or FISH negative result.
✓. ECOG performance status \<2.
Exclusion criteria
✕. Patients must not have previously received nal-IRI or any other form of irinotecan, conventional or liposomal.
✕. Patients who have received prior anti-cancer treatment with chemotherapy, endocrine therapy, immunotherapy or radiotherapy within 3 weeks (6 weeks for nitrosoureas or mitomycin-C) prior to starting study treatment.
✕. Radiation therapy encompassing more than 30% of bone marrow.
What they're measuring
1
CNS Overall Response Rate (ORR)
Timeframe: From Baseline up to 80 weeks after patient entry
. Significant chronic gastrointestinal disorder with diarrhea as a major symptom (i.e Crohn's disease, ulcerative colitis, malabsorption, or grade ≥ 2 diarrhea of any etiology at baseline)
✕. Have a serious concomitant systemic disorder (e.g. active infection including HIV, or cardiac disease) incompatible with the study (at the discretion of investigator), previous history of bleeding diathesis, or treatment with Sintrom.
✕. Patients who have symptomatic lymphangitis, dyspnoea at rest or meningeal carcinomatosis. (Patients with asymptomatic involvement may be enrolled in the study.)
✕. Patients must be recovered from any clinically relevant toxic effects of any prior surgery, radiotherapy or other therapy intended for the treatment of breast cancer. For peripheral neuropathy, up to CTCAE (v4.0) Grade 2 is acceptable for patients with pre-existing condition.
✕. Patients may not be receiving any other investigational or anticancer agents while on the study.