Halaven (eribulin mesylate)

P2, N=74, Recruiting, Fudan University

P3, N=378, Not yet recruiting, Shanghai Escugen Biotechnology Co., Ltd

P3, N=436, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.

P2; Active, not recruiting --> Completed

P3, N=1, Terminated, Suzhou Suncadia Biopharmaceuticals Co., Ltd. | N=104 --> 1 | Not yet recruiting --> Terminated; Sponsor R & D Strategy Adjustment]

P3, N=557, Active, not recruiting, Daiichi Sankyo | Trial completion date: Mar 2024 --> Oct 2025

These findings provide an epigenetic mechanism of action of eribulin, supporting its use early in the disease process for MET induction to prevent metastatic progression and chemoresistance. These findings warrant prospective clinical evaluation of the chemosensitizing effects of eribulin in the treatment-naive setting.

P3, N=27, Active, not recruiting, Spanish Breast Cancer Research Group | Recruiting --> Active, not recruiting | N=300 --> 27 | Trial completion date: Sep 2026 --> Nov 2024 | Trial primary completion date: Jun 2026 --> Nov 2024

P2, N=10, Not yet recruiting, Fudan University

P2, N=10, Not yet recruiting, Fudan University

P2; Changes in ctDNA can occur rapidly and reflect changes in patients' clinical tumour responses (NCT02681523).

P3, N=382, Not yet recruiting, Sichuan Baili Pharmaceutical Co., Ltd.

We found that eribulin-induced cell death was reduced by ferroptosis inhibitors; deferoxamine, an iron chelator and ferrostatin-1, a lipid peroxidation inhibitor...The combination of eribulin and ML210, a glutathione peroxidase 4-inhibiting ferroptosis inducer, had a synergistic effect on ferroptosis. Taken together, our findings show firstly that eribulin triggers ferroptosis in OCCC and this effect occurs via the suppression of the Nrf2-HO-1 signaling pathway, SOD activity and the promotion of lipid peroxidation. These findings suggest that eribulin-induced ferroptosis is associated with its anti-tumor effect and also could be a potential therapeutic target in OCCC.

P1, N=255, Recruiting, Enliven Therapeutics | Not yet recruiting --> Recruiting

A 46-year-old woman with estrogen receptor-positive, human epidermal growth factor receptor 2-negative metastatic breast cancer who had multiple LMs and bone metastases underwent seven lines of systemic therapy (paclitaxel/bevacizumab for 38 months; letrozole, nivolumab/fulvestrant, eribulin, gemcitabine/vinorelbine, high-dose toremifene/abemaciclib, and capecitabine for 21 months in total). However, owing to its adverse effects and the continued progression of the LMs, systemic therapy was switched to HAIC (40 mg/body epirubicin on day 1, 4 mg/body mitomycin C on days 1 and 15, and 500 mg/body 5-fluorouracil on days 1, 8, and 15; 28-day courses)...Our findings identify a potential window for the use of traditional chemotherapeutic agents such as anthracyclines. Novel strategies to improve drug delivery are warranted in the future.

P1, N=255, Not yet recruiting, Enliven Therapeutics

P1, N=8, Completed, City of Hope Medical Center | Active, not recruiting --> Completed

P1, N=15, Active, not recruiting, OHSU Knight Cancer Institute | Phase classification: P1b --> P1

P2, N=81, Not yet recruiting, Zhejiang Cancer Hospital

P1/2, N=154, Recruiting, Chia Tai Tianqing Pharmaceutical Group Co., Ltd. | N=89 --> 154 | Trial completion date: Oct 2025 --> Oct 2027 | Trial primary completion date: Mar 2025 --> Dec 2026

P2, N=30, Recruiting, Criterium, Inc. | Trial completion date: May 2025 --> Aug 2027 | Trial primary completion date: Nov 2023 --> Jun 2027

In the phase III TROPiCS-02 trial, intravenous sacituzumab govitecan demonstrated statistically significant and clinically meaningful improvements in progression-free survival and overall survival compared with physician's choice of chemotherapy (capecitabine, eribulin, gemcitabine or vinorelbine) in adults with metastatic HR+/HER2- breast cancer. Sacituzumab govitecan demonstrated an overall benefit in terms of health-related quality of life. Current evidence indicates that sacituzumab govitecan is an effective treatment option, with a generally manageable tolerability profile, for patients with pre-treated, unresectable locally advanced or metastatic HR+/HER2- breast cancer.

P3, N=404, Recruiting, BriaCell Therapeutics Corporation | Initiation date: Oct 2023 --> Feb 2024

P3, N=524, Not yet recruiting, Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.

P3, N=302, Recruiting, Sun Yat-sen University

P3, N=170, Recruiting, National Cancer Institute (NCI) | Suspended --> Recruiting

P3, N=333, Not yet recruiting, Intensity Therapeutics, Inc.

P2; Trial completion date: Jan 2024 --> Jan 2025 | Trial primary completion date: Jan 2024 --> Jan 2025

P1/2, N=132, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Aug 2024 | Trial primary completion date: Dec 2023 --> Aug 2024

P3, N=170, Suspended, National Cancer Institute (NCI) | N=465 --> 170

P3, N=200, Not yet recruiting, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Materials & MDA-MB 231 cells were treated with eribulin and paclitaxel, and the samples from 53 patients treated with neoadjuvant eribulin were compared with those from 14 patients who received the standard-of-care treatment using immunohistochemistry. Eribulin treatment caused significant DNA methylation changes in drug-tolerant persister TNBC cells, and it also elicited changes in the expression levels of epigenetic modifiers (DNMT1, TET1, DNMT3A/B) in vitro and in primary TNBC tumors. These findings provide new insights into eribulin's mechanism of action and potential biomarkers for predicting TNBC treatment response.

Postoperative adjuvant fluorouracil plus epirubicin HCl plus cyclophosphamide(FEC)plus paclitaxel(PTX)therapy was administered...Capecitabine was selected for treatment of the recurrent lesion...At this time, eribulin mesylate was selected, along with intensity-modulated radiation therapy(IMRT)...Subsequently, liver metastasis was detected, and the drug was switched to vinorelbine ditartrate(a drug with less non-hematological toxicity)...About half a year later, ie, in October 2021(11 years after the surgery), we detected an increase in the size of the liver metastasis and selected atezolizumab and nab-PTX for treatment. Applicable regimens of drug therapy are still available at present and drug therapy has been continued based on a discussion and mutual understanding of the adverse reactions, etc. with the patient. Few reports have been published concerning long-term survivors among TN breast cancer cases.

Our real-world study suggests that eribulin may be a potential treatment option for MBC patients who fail a prior PI3K inhibitor.

Promising antitumor activity was observed with E7389-LF in combination with nivolumab in patients with GC, and no new safety signals were observed, compared with either monotherapy.

P1, N=0, Withdrawn, OHSU Knight Cancer Institute | N=25 --> 0 | Not yet recruiting --> Withdrawn

The combination of eribulin and pembrolizumab demonstrated promising activity in LPS and angiosarcoma.

P2, N=1460, Active, not recruiting, UNICANCER | Trial completion date: Dec 2023 --> Dec 2024

Results show complex synergistic interactions between eribulin, fulvestrant, and palbociclib, and point to a particularly robust synergy when combining all three drugs.

P1/2, N=106, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Dec 2024 | Trial primary completion date: Dec 2023 --> Dec 2024

P2, N=30, Recruiting, Australia New Zealand Gynaecological Oncology Group

P2, N=252, Recruiting, Guangdong Provincial People's Hospital | Not yet recruiting --> Recruiting