Evaluation of the Efficacy and Safety of Nal-IRI for Progressing Brain Metastases in Breast Cancer Patients

Sponsor
MedSIR
Study ID
NCT03328884
Phase
PHASE2
Status
Completed

Conditions

  • Breast Cancer Metastatic

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Irinotecan (CPT-11) liposome — DRUG
    nal-IRI (nanoliposomal irinotecan, also known as MM-398 and PEP02) is irinotecan free base, (also known as CPT-11) a topoisomerase 1 inhibitor, encapsulated in a liposome drug delivery system. nal-IRI will be administered 50 mg/m2 on D1 of a 14-day cycle in monotherapy.

Study Details

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.

Key Dates

Start date
May 2, 2017
Status verified
Apr 2025
Primary completion
Aug 31, 2018
Completion
Apr 2, 2025

Study Design

Enrollment
55 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: nal-IRI
    This is a single arm study. After signing the informed consent form, patients will start treatment with nal-IRI. nal-IRI will be administered 50 mg/m2 on D1 of a 14-day cycle in monotherapy.

Primary Outcome Measure

CNS Overall Response Rate (ORR) [ Time Frame: From Baseline up to 80 weeks after patient entry ]

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