ArticleBreast cancer research and treatment2021
Phase I study of liposomal irinotecan in patients with metastatic breast cancer: findings from the expansion phase.
Article in Breast cancer research and treatment, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01770353 (A Phase I Study in Patients Treated With MM-398), which is not on this map. Cited by 32 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase I Study in Patients Treated With MM-398 (Nanoliposomal Irinotecan, Nal-IRI) to Determine Tumor Drug Levels and to Evaluate the Feasibility of Ferumoxytol Magnetic Resonance Imaging to Measure Tumor Associated Macrophages and to Predict Patient Response to Treatment
Who cites it
32 citing papers in PubMed, 44 citations in OpenAlex.
- Natural Product-Based Nanomedicine in the Treatment of Breast Cancer.Pharmaceutics · 2026Review
- Smart nanocarriers in triple-negative breast cancer: recent advances in targeting and translational application.Drug delivery and translational research · 2026Review
- Engineering smart polymeric lipid nanoparticles for breast cancer: AI-guided formulation design, biological barriers, and translational constraints.Journal of nanobiotechnology · 2026Review
- Research progress on precision targeted therapy strategies for breast cancer based on tumor microenvironment.iScience · 2026Review
- Effect of clinically relevant iron oxide nanoparticles on macrophage polarization, tumor growth and tumor microenvironment modulation.Journal of controlled release : official journal of the Controlled Release Society · 2026Article
- Botanical Adjuvants in Oncology: A Review on Natural Compounds in Synergy with Conventional Therapies as Next-Generation Enhancers of Breast Cancer Treatment.Current issues in molecular biology · 2026Review
- Article
- Camptothecin in Cancer Therapy: Current Challenges and Emerging Strategies with Nanoemulsions.Pharmaceutics · 2025Review
- Overview of Preclinical and Clinical Trials of Nanoparticles for the Treatment of Brain Metastases.Pharmaceutics · 2025Review
- Nanotechnology Driven Lipid and Metalloid Based Formulations Targeting Blood-Brain Barrier (3B) for Brain Tumor.Indian journal of microbiology · 2025Article
- The research progress on meningeal metastasis in solid tumors.Discover oncology · 2025Review
- Drug Treatment Direction Based on the Molecular Mechanism of Breast Cancer Brain Metastasis.Pharmaceuticals (Basel, Switzerland) · 2025Review
- Intravenous liposomal irinotecan in metastatic triple-negative breast cancer after ≥ 2 prior lines of chemotherapy: a phase Ib study.Nature communications · 2025Article
- Central Nervous System Metastases in Breast Cancer.Current treatment options in oncology · 2025Review
- Review
- Review
- Liposomal irinotecan (HR070803) in combination with 5-fluorouracil and leucovorin in patients with advanced solid tumors: a phase 1b dose-escalation and expansion study.Investigational new drugs · 2024Article
- Targeting brain tumors with innovative nanocarriers: bridging the gap through the blood-brain barrier.Oncology research · 2024Review
- Patterns of immune evasion in triple-negative breast cancer and new potential therapeutic targets: a review.Frontiers in immunology · 2024Review
- Molecular signaling network and therapeutic developments in breast cancer brain metastasis.Advances in cancer biology - metastasis · 2023Article
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors at 8 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
purposeMetastatic breast cancer (mBC) remains incurable and is associated with low survival rates. This study assessed the efficacy and safety of liposomal irinotecan in heavily pretreated patients with mBC, with or without active brain metastases (BM).
methodsFollowing the dose escalation phase and determination of recommended phase 2 dose, the expansion phase of this phase I, open-label, non-randomized study, assigned adult women to cohorts based on mBC subtype: cohort 1, hormone receptor +/human epidermal growth factor receptor 2-; cohort 2, triple-negative breast cancer; or cohort 3, any mBC subtype with active BM. Patients received liposomal irinotecan 50 or 70 mg/m
resultsFor non-central nervous system (non-CNS) disease across all cohorts (intent-to-treat population, N = 29), the ORR was 34.5% (95% confidence interval: 17.94-54.33), with a BOR of partial response in 10 patients (34.5%), stable disease in five (17.2%), progressive disease in 10 (34.5%); four patients were unevaluable (13.8%). The ORR for the CNS cohort was 30.0% (95% confidence interval: 6.67-65.25) using modified Response Evaluation Criteria in Solid Tumors. Common grade 3 or higher TEAEs were diarrhea (27.6%), nausea (17.2%), fatigue (13.8%), asthenia (10.3%), and hypokalemia (10.3%). Serious treatment-related TEAEs were reported in six patients (20.7%). No treatment-related TEAEs resulted in death.
conclusionsLiposomal irinotecan monotherapy demonstrated antitumor activity in heavily pretreated patients with mBC, with or without BM. The observed safety profile was consistent with that in previous studies. CLINICAL
trial registrationTrial registration ID NCT01770353.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.