Trial reportJournal of hematology & oncology2016
Phase II trial of utidelone as monotherapy or in combination with capecitabine in heavily pretreated metastatic breast cancer patients.
Trial report in Journal of hematology & oncology, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07363330 (Utidelone Combined With Toripalimab in Patients With Pretreated Recurrent or Metastatic Cervical Cancers), which is not on this map. Cited by 22 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.
Utidelone Combined With Toripalimab in Patients With Pretreated Recurrent or Metastatic Cervical Cancers: a Single-Arm, Phase II Study
Who cites it
22 citing papers in PubMed.
- Utidelone in patients with advanced soft tissue sarcoma refractory to anthracycline and antiangiogenic therapy (UTISARC): a single-arm phase II study.BMC medicine · 2026Trial
- Utidelone exhibits favorable responses in refractory patients with advanced breast cancer.Translational cancer research · 2026Article
- Atrial fibrillation during palliative chemotherapy with utidelone: a case report.Frontiers in oncology · 2026Article
- Utidelone-associated chemotherapy-induced peripheral neuropathy: an evidence-stratified narrative review of mechanisms, risk identification, and management strategies.Frontiers in oncology · 2026Review
- Utidelone suppresses PDAC growth and enhances gemcitabine therapy by inducing immunogenic cell death.iScience · 2025Article
- Effects of Electroacupuncture and Mecobalamin for Utidelon-Induced Peripheral Neuropathy in Breast Cancer Patients: A Randomized Controlled Clinical Trial.Journal of pain research · 2025Article
- Utidelone combined with anti‑angiogenic therapy for the treatment of anthracycline/taxane‑treated and endocrine‑resistant HROncology letters · 2025Article
- Efficacy and safety of utidelone in pretreated patients with metastatic breast cancer in China: a multicenter, real-world study.Therapeutic advances in medical oncology · 2025Article
- Real world analysis of the efficacy and safety of eribulin compared to utidelone in combination with capecitabine for the treatment of metastatic breast cancer.Cancer cell international · 2024Article
- Efficacy and safety of utidelone for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer who have failed standard second-line treatment: A phase 2 clinical trial (BG01-1801).Cancer pathogenesis and therapy · 2024Article
- Cost-effectiveness of utidelone and capecitabine versus monotherapy in anthracycline- and taxane-refractory metastatic breast cancer.Frontiers in pharmacology · 2024Article
- Efficacy and safety of utidelone plus capecitabine in advanced first-line therapy for metastatic breast cancer: A multicenter real-world study.Surgery open science · 2023Article
- Epothilones as Natural Compounds for Novel Anticancer Drugs Development.International journal of molecular sciences · 2023Review
- Efficacy of electroacupuncture in the treatment of peripheral neuropathy caused by Utidelone: Study protocol for a randomized controlled trial.Frontiers in neurology · 2023Article
- Current Therapeutic Strategies for Metastatic Triple-Negative Breast Cancer: From Pharmacists' Perspective.Journal of clinical medicine · 2022Review
- Utidelone inhibits growth of colorectal cancer cells through ROS/JNK signaling pathway.Cell death & disease · 2021Article
- Ganglioside Monosialic Acid Alleviates Peripheral Neuropathy Induced by Utidelone Plus Capecitabine in Metastatic Breast Cancer From a Phase III Clinical Trial.Frontiers in oncology · 2020Article
- Recent advances with cyclin-dependent kinase inhibitors: therapeutic agents for breast cancer and their role in immuno-oncology.Expert review of anticancer therapy · 2019Review
- Bcl-2 promotes metastasis through the epithelial-to-mesenchymal transition in the BCap37 medullary breast cancer cell line.Oncology letters · 2018Article
- MAT1 correlates with molecular subtypes and predicts poor survival in breast cancer.Chinese journal of cancer research = Chung-kuo yen cheng yen chiu · 2018Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThe treatment of metastatic breast cancer (MBC) remains a great clinical challenge as drug resistance frequently develops. Alternative agents that can overcome drug resistance would offer new therapeutic options. The primary aim of this phase II study was to evaluate the efficacy and safety of utidelone as a monotherapy or in combination with capecitabine in metastatic breast cancer patients previously treated with and resistant to anthracyclines and taxanes.
methodsIn two open-label, noncomparative clinical studies, patients with metastatic breast cancer who previously received anthracycline- and/or taxane-containing regimens were given (1) 25 to 35 mg/m(2)/day intravenously infused utidelone, once daily for 5 days, in combination with 14 days of 2000 mg/m(2) capecitabine, divided in two equal daily oral doses or (2) 40 mg/m(2)/day intravenously infused utidelone, once daily for 5 days. These regimens were administered per each 21-day treatment cycle, and the maximum of treatment cycles allowed per protocol is 6. Objective response rate (ORR), progression-free survival (PFS), and tolerability were evaluated.
resultsIn the combination study, 33 patients completed a median of 6 cycles of therapy, which was the highest cycles a trial patient could receive under the criteria of the study protocol. Efficacy was evaluated (n = 32) with an ORR of 42.4 % (FAS, 95 % CI, 26.6, 60.9) and a median PFS of 7.9 (FAS, 95 % CI, 6.1, 9.8) months. The monotherapy study (n = 63) resulted in an ORR of 28.57 % (FAS, 95 % CI, 18.4, 40.6) and a median PFS of 5.4 (FAS, 95 % CI, 2.9, 9.8) months. In both studies, common toxicities associated with utidelone administration included peripheral neuropathy, fatigue, myalgia, and arthralgia, but the toxicities were limited and manageable. Notably, very mild myelosuppression, low liver and renal toxicities, and very limited gastrointestinal toxic effect were observed, in contrast to other agents in the same class.
conclusionsUtidelone showed promising efficacy, tolerability, and advantageous safety profiles in the treatment of patients with advanced anthracycline/taxane-refractory metastatic breast cancer and may offer new treatment options to overcome drug resistance.
trial registrationCHiCTR-TRC-13004205 , registered on August 15, 2013.
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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.