BridgeMD
Multicenter open-label, phase II trial, to evaluate the efficacy and safety of nal-IRI for progressing brain metastases in patients with HER2-negative breast cancer.
EU CTIS ID: 2024-514999-41-00
What this study is testing
To assess the efficacy -defined as intracranial (IC) objective response rate (ORR)- of nal-IRI in patients with HER2-negative metastatic breast cancer who have documented central nervous system (CNS) progression following WBRT, SRS and/or surgery, as determined by the Response Assessment in Neuro-Oncology Brain Metastases (RANO-BM) criteria with central confirmation by a volumetric parameter.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Female or male patients > 18 years
- Life expectancy >12 weeks.
- Participants of childbearing potential must agree to use at least efficient contraception method (even though it is recommendable for them to use a highly effective method) prior to study entry and for the duration of study participation as well as a negative serum pregnancy test within 7 days of study enrolment and at the end of treatment visit.
- Ability to understand and the willingness to sign a written informed consent.
- Patients must have sufficient organ and marrow function as defined below: a. Hematopoietic parameters: i. Absolute neutrophil count (ANC) ≥ 1,5 x 109 /L ii. Platelets ≥ 100 x 109 /L iii. Haemoglobin ≥ 9 mg/dL b. Hepatic parameters: i. Total bilirubin ≤ 1.5 mg/dL ii. AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal c. Renal parameters: i. Creatinine ≤ 1.5 X institutional upper limits of normal, OR ii. Creatinine clearance ≥ 60 mL/min/1.73 m2 for pts w/ creatinine levels > institutional normal.
- Patients must have a diagnosis of metastatic breast cancer.
You likely can't join if
- Patients must not have previously received nal-IRI or any other form of irinotecan, conventional or liposomal.
- History of other malignancies, which could affect compliance with the protocol or interpretation of the results. Patients with malignancies diagnosed more than 5 years prior to study day 1, adequately treated carcinoma in situ of the cervix or basal or squamous cell skin are generally eligible.
- NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings.
- Active infection or an unexplained fever >38.5°C (excluding tumoral fever), which in the physician’s opinion might compromise the patient’s health.
- Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study.
- Current use or any use in the last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
See the full eligibility criteria
Who can join
- Female or male patients > 18 years
- Life expectancy >12 weeks.
- Participants of childbearing potential must agree to use at least efficient contraception method (even though it is recommendable for them to use a highly effective method) prior to study entry and for the duration of study participation as well as a negative serum pregnancy test within 7 days of study enrolment and at the end of treatment visit.
- Ability to understand and the willingness to sign a written informed consent.
- Patients must have sufficient organ and marrow function as defined below: a. Hematopoietic parameters: i. Absolute neutrophil count (ANC) ≥ 1,5 x 109 /L ii. Platelets ≥ 100 x 109 /L iii. Haemoglobin ≥ 9 mg/dL b. Hepatic parameters: i. Total bilirubin ≤ 1.5 mg/dL ii. AST (SGOT)/ALT (SGPT) ≤ 2.5 X institutional upper limit of normal c. Renal parameters: i. Creatinine ≤ 1.5 X institutional upper limits of normal, OR ii. Creatinine clearance ≥ 60 mL/min/1.73 m2 for pts w/ creatinine levels > institutional normal.
- 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.
What rules you out
- Patients must not have previously received nal-IRI or any other form of irinotecan, conventional or liposomal.
- History of other malignancies, which could affect compliance with the protocol or interpretation of the results. Patients with malignancies diagnosed more than 5 years prior to study day 1, adequately treated carcinoma in situ of the cervix or basal or squamous cell skin are generally eligible.
- NYHA Class III or IV congestive heart failure, ventricular arrhythmias or uncontrolled blood pressure. Or known abnormal ECG with clinically significant abnormal findings.
- Active infection or an unexplained fever >38.5°C (excluding tumoral fever), which in the physician’s opinion might compromise the patient’s health.
- Patients with other significant disease or disorders that, in the Investigator's opinion, would exclude the patient from the study.
- Current use or any use in the last two weeks of strong CYP3A-enzyme inducers/inhibitors and/or strong UGT1A inhibitors
- Known hypersensitivity to any of the components of nanoliposomal irinotecan (nal-IRI), other liposomal irinotecan formulations or irinotecan.
- Pregnant or lactating women.
- 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.
- 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 or any anti-vitamin K.
- 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.
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.