Trial reportClinical breast cancer2011
A phase II study of sagopilone (ZK 219477; ZK-EPO) in patients with breast cancer and brain metastases.
Trial report in Clinical breast cancer, 2011. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 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.
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Who cites it
18 citing papers in PubMed.
- Phase II study of irinotecan and temozolomide in breast cancer patients with progressing central nervous system disease.Breast cancer research and treatment · 2019Trial
- ATTAIN: Phase III study of etirinotecan pegol versus treatment of physician's choice in patients with metastatic breast cancer and brain metastases.Future oncology (London, England) · 2019Trial
- Phase II trial of patupilone in patients with brain metastases from breast cancer.Neuro-oncology · 2014Trial
- Reactive astrocytic S1P3 signaling modulates the blood-tumor barrier in brain metastases.Nature communications · 2018Article
- Repositioning Microtubule Stabilizing Drugs for Brain Disorders.Frontiers in cellular neuroscience · 2018Review
- Systemic therapy of brain metastases: non-small cell lung cancer, breast cancer, and melanoma.Neuro-oncology · 2017Review
- Alterations in Pericyte Subpopulations Are Associated with Elevated Blood-Tumor Barrier Permeability in Experimental Brain Metastasis of Breast Cancer.Clinical cancer research : an official journal of the American Association for Cancer Research · 2016Article
- Targeted Therapies for Brain Metastases from Breast Cancer.International journal of molecular sciences · 2016Review
- Cancer and the metastatic substrate.Ecancermedicalscience · 2016Review
- Review
- CNS metastases in breast cancer: old challenge, new frontiers.Clinical cancer research : an official journal of the American Association for Cancer Research · 2013Review
- Clinical outcomes and treatment practice patterns of patients with HER2-positive metastatic breast cancer in the post-trastuzumab era.Breast (Edinburgh, Scotland) · 2013Article
- Progress in the biological understanding and management of breast cancer-associated central nervous system metastases.The oncologist · 2013Article
- Emerging treatment options for the management of brain metastases in patients with HER2-positive metastatic breast cancer.Breast cancer research and treatment · 2013Review
- Breast cancer brain metastases: new directions in systemic therapy.Ecancermedicalscience · 2013Article
- TPI-287, a new taxane family member, reduces the brain metastatic colonization of breast cancer cells.Molecular cancer therapeutics · 2012Article
- Treatment of Breast Cancer Brain Metastases.Current breast cancer reports · 2012Article
- Clinical trial design in brain metastasis: approaches for a unique patient population.Current oncology reports · 2012Article
Corrections and comments
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Authors and funding
11 authors.
Funding
Abstract
unlabelledTreatments for women with recurrent brain metastases from breast cancer are limited. In this phase II study,we administered sagopilone to patients with breast cancer and brain metastases. We observed modest activity with a central nervous system objective response rate of 13.3%; however, median PFS was disappointing. Further studies should focus on other agents to treat this challenging clinical problem.
backgroundPatients with progressive metastatic breast cancer to the central nervous system (CNS) have limited treatment options. PATIENTS AND
methodsWe conducted a phase II study of sagopilone, an epothilone B analogue that crosses the blood-brain barrier, in patients with breast cancer brain metastases. Women were treated with 16 mg/m(2) or 22 mg/m(2) intravenously every 21 days. The primary endpoint was CNS objective response rate (ORR). Secondary endpoints included toxicity, progression-free survival (PFS), and overall survival (OS). Using modified, high-resolution magnetic resonance angiography (MRA), we also evaluated changes in vessel tortuosity with treatment.
resultsFifteen women were enrolled; all had progressive CNS disease despite whole-brain radiotherapy. Two patients achieved a partial response (ORR, 13.3%) and remained in the study for 6 cycles. Responses were not associated with normalization of tumor-associated vessels on correlative imaging studies. Median PFS and OS were 1.4 months and 5.3 months, respectively. The most common grade 3 toxicities were lymphopenia and fatigue. Enrollment was stopped prematurely because of limited observed activity and slow accrual.
conclusionsSagopilone was associated with modest CNS activity in patients with breast cancer; however median PFS was disappointing. Further studies should examine other potentially active agents and/or combinations for this challenging clinical problem.
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