Halaven (eribulin mesylate)

P2, N=14, Recruiting, MedSIR | N=28 --> 14

P1/2, N=106, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2024 --> Jun 2025 | Trial primary completion date: Dec 2024 --> Jun 2025

P=N/A, N=80, Recruiting, Hunan Cancer Hospital

P3, N=504, Not yet recruiting, Shanghai Escugen Biotechnology Co., Ltd

P2, N=40, Not yet recruiting, Fudan University

P3, N=254, Active, not recruiting, Sichuan Kelun Pharmaceutical Research Institute Co., Ltd. | Trial completion date: Dec 2024 --> Mar 2025

We demonstrate in our exploratory study that biomarkers involved in the process of EMT could have a prognostic impact in a cohort of patients with BC uniformly treated and with long-term follow-up. Genes known to be involved in EMT were associated with improved eribulin efficacy, while suggesting a poorer outcome with CDK4/6i.

Hormonal or endocrine therapy includes selective estrogen receptor modulators (SERMs) such as raloxifene, tamoxifen and toremifene, selective estrogen-receptor degraders (SERDs) including elacestrant and fulvestrant, and aromatase inhibitors such as anastrozole, letrozole, and exemestane...These agents include taxanes (docetaxel, nab-paclitaxel, and paclitaxel), anthracyclines (doxorubicin, epirubicin), anti-metabolites (capecitabine, gemcitabine, fluorouracil, methotrexate), alkylating agents (carboplatin, cisplatin, and cyclophosphamide), and drugs that target microtubules (eribulin, ixabepilone, ado-trastuzumab emtansine). Patients with ER-positive tumors are treated with 5-10 years of endocrine therapy and chemotherapy. For patients with metastatic breast cancer, standard first-line and follow-up therapy options include targeted approaches such as CDK4/6 inhibitors, PI3K inhibitors, PARP inhibitors, and anti-PDL1 immunotherapy, depending on the tumor type and molecular profile.

P2, N=57, Active, not recruiting, Dana-Farber Cancer Institute | Trial primary completion date: Aug 2025 --> Jul 2024

P3, N=168, Recruiting, Shanghai Yizhong Pharmaceutical Co., Ltd. | Trial completion date: Jul 2025 --> Dec 2025 | Trial primary completion date: Jul 2025 --> Dec 2025

These findings are paradigm-shifting given that chemotherapy is traditionally considered immunosuppressive. Our study reveals the novel effect of low-dose eribulin chemotherapy in inhibiting bladder tumor growth by enhancing anti-tumor NK cell immunity, challenging previous assumptions and opening new therapeutic approaches to improve antitumor immunity.

P1/2, N=30, Active, not recruiting, National Taiwan University Hospital | Trial completion date: Jun 2023 --> Dec 2024

P1/2, N=358, Recruiting, GI Innovation, Inc. | N=92 --> 358 | Trial completion date: Jun 2025 --> Apr 2027 | Trial primary completion date: Apr 2025 --> Nov 2025

P1, N=42, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting | Initiation date: Nov 2024 --> Aug 2025

FRα-targeting ADCs, including MIRV, demonstrated definite efficacy and good safety as novel choices for second-line and beyond treatment of advanced or recurrent ovarian cancer. Patients with high FRα expression showed ORR and PFS benefits similar to those in the overall cohort.

In patients with MBC, the recommended phase 2 dose of rebastinib associated with pharmacodynamic evidence of TIE2 inhibition is either 50 or 100 mg PO BID in combination with paclitaxel or eribulin.

P2, N=12, Recruiting, Sun Yat-sen University

In 1 pt, eribulin and abraxane did not have the same effect; ESR1 polyclonality was maintained. One pt with 1 ESR1 clone after 2.5 years of fulvestrant+palbociclib developed 15 additional clones after 1.5 years of an experimental SERD+everolimus. Another pt with 1 ESR1 clone after anastrozole+palbociclib developed 9 additional ESR1 clones after 10 months of AKT inhibition+anastrozole... This is the first investigation of dynamic changes in extreme ESR1 polyclonality in association with treatment outcomes in pts with ER+ MBC. Capecitabine was associated with a decrease in detectable ESR1-mutant clones, while increased polyclonality was found at progression on SERD+everolimus, AKT-inhibitor+AI, and an ADC. Although extreme ESR1 polyclonality is rare, understanding mutational dynamics will improve our understanding of polyclonality more broadly and its impact on treatment resistance.

By comparing eribulin-resistant breast cancer cell lines, we confirmed that BYL-719 could effectively overcome drug resistance. Finally, we believe that drug resistance can be overcome by targeting the BCSCs. Conjugation of BYL-719 with other anti-neoplastic agents may be a promising treatment for this in clinic.

In the analysis using human- leukemia monocytic cell, the concentration of eribulin released from TROP2-eribuilin was significantly reduced by the use of an Fc receptor inhibitor (P < 0.05). These results revealed that Fcγ-receptor-mediated uptake by alveolar macrophages releases cytotoxic payload into lung tissue, helping to clarify the pathogenesis of ADC-induced ILD.

P1/2, N=41, Recruiting, Colette Shen | Trial primary completion date: Sep 2024 --> Nov 2025

Subgroup analysis was conducted on chemotherapy regimens, with and without eribulin. Despite variations in chemotherapy regimens, patients with ABC or MBC and high ALC exhibited longer PFS and PPS (HR = 0.45, 95% CI: 0.30-0.67, P < 0.0001), PFS and TTF (HR = 0.39, 95% CI: 0.20-0.78, P = 0.008), and OS (HR = 0.71, 95% CI: 0.62-0.82, P < 0.00001; HR = 0.5, 95% CI: 0.35-0.70, P < 0.0001). The results of this meta-analysis suggest that baseline ALC, as an immune marker, can serve as an effective prognostic indicator for ABC or MBC.

To advance our understanding of the role of breast cancer driver genes' mutational status with pathological complete response (pCR; ypT0/isypN0) prediction and to identify distinct gene sets for MTIs like eribulin and paclitaxel, we carried out targeted genomic (n = 50) and whole transcriptomic profiling (n = 64) of TNBC tumor samples from the Japan Breast Cancer Research Group 22 (JBCRG-22) clinical trial. Differential enrichment analysis of the HRD-high group posttreatment tumors revealed significant correlation (p = 0.006) of the glycan degradation pathway. FGFR2 expression and the differentially enriched pathways play a role in the response and resistance to MTIs containing carboplatin treatment in TNBC patients.

ErCb demonstrated favorable efficacy and tolerability in patients with heavily pre-treated mBC, especially TNBC. The findings of the current study warrant further investigation of the application of this combination in earlier lines of mBC treatment.

P2, N=252, Recruiting, Guangdong Provincial People's Hospital | Initiation date: Jan 2024 --> Sep 2024

P3, N=350, Recruiting, Shanghai Fudan-Zhangjiang Bio-Pharmaceutical Co., Ltd. | Not yet recruiting --> Recruiting

P2, N=16, Completed, Italian Sarcoma Group | Recruiting --> Completed | Trial completion date: Apr 2024 --> Sep 2024 | Trial primary completion date: Apr 2024 --> Sep 2024

P1, N=221, Terminated, M.D. Anderson Cancer Center | Trial completion date: Dec 2024 --> Sep 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2024 --> Sep 2024; Administratively Complete

P1, N=33, Not yet recruiting, National Cancer Institute (NCI)

P1/2, N=6, Terminated, M.D. Anderson Cancer Center | N=25 --> 6 | Trial completion date: Dec 2025 --> Sep 2024 | Active, not recruiting --> Terminated | Trial primary completion date: Dec 2025 --> Sep 2024; The sponsor terminated support for this study

P2, N=35, Active, not recruiting, M.D. Anderson Cancer Center | Trial completion date: Dec 2024 --> Dec 2025 | Trial primary completion date: Dec 2024 --> Dec 2025

Patients receiving Dato-DXd had statistically significant and clinically meaningful improvement in PFS and a favorable and manageable safety profile, compared with ICC. Results support Dato-DXd as a novel treatment option for patients with inoperable/metastatic HR+/HER2‒ breast cancer who have received one to two previous lines of chemotherapy in this setting.

The analysis revealed that the six most effective neoadjuvant treatment regimens for HR+/HER2- breast cancer were: CT(A)+olaparib (82.5%), CT(A)+nivolumab (76.5%), Com (74.9%), CT (72.1%), Mono+eribulin (72.0%), and CT(A)+pembrolizumab (70.4%).Paired meta-analysis for pathological complete response (pCR) found no statistically significant distinction between treatment regimens that included both anthracycline and immunosuppressants and regimens that relied solely on anthracycline chemotherapy(OR:1.14, 95%ci 0.79-1.64, I2 = 71%, P=0.50). Although pCR is valuable in assessing the effect of neoadjuvant therapy in some cases, prognostic prediction and efficacy assessment in patients with HR+/HER2- breast cancer should be based on a combination of broader clinical and biological characteristics. PROSPERO https://www.crd.york.ac.uk/prospero/display_record.php?ID=CRD42024534539, CRD42024501740.

This real-world study demonstrates that for patients with HR+/HER2- mBC, chemotherapy provides relatively limited survival benefit which decreases with each additional chemotherapy line, and highlights the need for improved treatment options.

P1/2 | N=580 | Recruiting | Sponsor: Hoffmann-La Roche | N=242 ➔ 580 | Trial completion date: May 2026 ➔ May 2028 | Trial primary completion date: May 2026 ➔ May 2028

P3, N=201, Suspended, Academic and Community Cancer Research United | Trial completion date: Dec 2023 --> Oct 2024

P3, N=732, Active, not recruiting, AstraZeneca | Trial primary completion date: Aug 2025 --> Jul 2024

Eribulin and capecitabine sensitivity may vary based on HER2 expression in patients with HER2-low and HER2-null breast cancer. Prognosis was similar between the HER2-low and the HER2-null groups.

Further analyses indicate that anlotinib plus eribulin treatment results in micro-vessel density and PD-L1 expression alterations, suggesting a potential impact on the tumor microenvironment. This study extensively explored the combination regimen at multiple levels and its underlying molecular mechanism in RLPS, thus providing a foundation for translational medicine research.

Using eribulin in the first- or second-line may demonstrate the non-inferiority of HRQoL compared to S-1, an oral 5-fluorouracil derivative, while maintaining OS. The time of the first clinical deterioration was similar between the two groups and OS significantly increased in eribulin-treated patients. This study was funded by CSPOR-BC and Eisai CO., Ltd.

Genomic features including TMB, HRD, and TP53 mutations and transcriptomic features related to immune cell profiles and cell cycle may distinguish responders. Our findings provide insights for further exploring the combination regimen and its biomarkers in these tumors.

P3, N=550, Recruiting, Jazz Pharmaceuticals | Not yet recruiting --> Recruiting | Trial completion date: Apr 2031 --> Nov 2031 | Trial primary completion date: Apr 2031 --> Sep 2028