Halaven (eribulin mesylate)
/ Eisai, Knight Therap, Shenzhen Kexing Pharma
- LARVOL DELTA
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September 11, 2023
Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
(clinicaltrials.gov)
- P1/2 | N=242 | Recruiting | Sponsor: Hoffmann-La Roche | Active, not recruiting ➔ Recruiting
Enrollment open • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • PD-L1
August 27, 2024
Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
(clinicaltrials.gov)
- 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
Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • PD-L1
June 09, 2023
Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
(clinicaltrials.gov)
- P1/2 | N=242 | Active, not recruiting | Sponsor: Hoffmann-La Roche | N=133 ➔ 242 | Trial completion date: May 2024 ➔ May 2026 | Trial primary completion date: May 2024 ➔ May 2026
Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • PD-L1
April 10, 2020
Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
(clinicaltrials.gov)
- P1/2 | N=280 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Aug 2021 ➔ Jun 2022 | Trial primary completion date: Aug 2021 ➔ Jun 2022
Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • PD-L1
June 09, 2022
Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
(clinicaltrials.gov)
- P1/2 | N=280 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Mar 2023 ➔ Sep 2023 | Trial primary completion date: Mar 2023 ➔ Sep 2023
Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • PD-L1
November 14, 2022
Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
(clinicaltrials.gov)
- P1/2 | N=280 | Active, not recruiting | Sponsor: Hoffmann-La Roche | Recruiting ➔ Active, not recruiting | Trial completion date: Sep 2023 ➔ May 2024 | Trial primary completion date: Sep 2023 ➔ May 2024
Enrollment closed • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • PD-L1
May 06, 2020
Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
(clinicaltrials.gov)
- P1/2 | N=280 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: Jun 2022 ➔ May 2023 | Trial primary completion date: Jun 2022 ➔ May 2023
Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • PD-L1
February 06, 2018
Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
(clinicaltrials.gov)
- P1/2 | N=260 | Not yet recruiting | Sponsor: Hoffmann-La Roche
New P1/2 trial • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • PD-L1
November 29, 2025
Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
(clinicaltrials.gov)
- P1/2 | N=792 | Recruiting | Sponsor: Hoffmann-La Roche | N=580 ➔ 792 | Trial completion date: May 2028 ➔ Sep 2030 | Trial primary completion date: May 2028 ➔ Sep 2030
Enrollment change • Trial completion date • Trial primary completion date • Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • PD-L1
February 09, 2023
Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
(clinicaltrials.gov)
- P1/2 | N=133 | Active, not recruiting | Sponsor: Hoffmann-La Roche | N=280 ➔ 133
Enrollment change • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • PD-L1
March 02, 2018
Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
(clinicaltrials.gov)
- P1/2 | N=260 | Recruiting | Sponsor: Hoffmann-La Roche | Not yet recruiting ➔ Recruiting | Initiation date: Feb 2018 ➔ Mar 2018
Enrollment open • Trial initiation date • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • PD-L1
July 08, 2020
Morpheus-TNBC: A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
(clinicaltrials.gov)
- P1/2 | N=280 | Recruiting | Sponsor: Hoffmann-La Roche | Trial completion date: May 2023 ➔ Jan 2023 | Trial primary completion date: May 2023 ➔ Jan 2023
Trial completion date • Trial primary completion date • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • PD-L1
March 26, 2026
ROSETTA Breast-01: The Effects and Safety of Pumitamig in Patients With Triple-Negative Breast Cancer
(clinicaltrials.gov)
- P3 | N=558 | Recruiting | Sponsor: BioNTech SE | N=144 ➔ 558
Enrollment change • Trial initiation date • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ER • HER-2 • PGR
July 24, 2025
First-line (1L) datopotamab deruxtecan (Dato-DXd) vs chemotherapy in patients with locally recurrent inoperable or metastatic triple-negative breast cancer (mTNBC) for whom immunotherapy was not an option: Primary results from the randomised, phase III TROPION-Breast02 trial
(ESMO 2025)
- P1, P3 | "Methods Adult pts with previously untreated locally recurrent inoperable or mTNBC, for whom immunotherapy was not an option, were randomised 1:1 to Dato-DXd (6 mg/kg IV Q3W) or investigator's choice of chemotherapy (ICC; [nab]-paclitaxel/ capecitabine/ eribulin mesylate/ carboplatin). The Dato-DXd safety profile was manageable. Results support Dato-DXd as the new 1L standard of care."
Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • PD-L1
March 25, 2026
Marine-Derived Anticancer Compounds and their Clinical Status.
(PubMed, Anticancer Agents Med Chem)
- "Marine sources offer a wide variety of compounds, and modifying them provides researchers with new opportunities for drug development. Many marine-derived compounds have already shown strong pharmacological effects, with some even proven in clinical use. New studies suggest that marine compounds could also play an important role in anticancer drug delivery systems, making them a promising option for future treatments."
Journal • Oncology
July 24, 2025
Sacituzumab tirumotecan (sac-TMT) vs investigator's choice of chemotherapy (ICC) in previously treated locally advanced or metastatic hormone receptor-positive, HER2-negative (HR+/HER2-) breast cancer (BC): Results from the randomized, multi-center phase III OptiTROP-Breast02 study
(ESMO 2025)
- P3 | "Background Sac-TMT is a TROP2 ADC developed with a novel linker to conjugate the payload, a belotecan-derivative topoisomerase I inhibitor...Methods Pts with HR+/HER2- BC who had progression on CDK4/6 inhibitors and received at least one prior line of chemotherapy in the advanced/metastatic setting were randomized (1:1) to receive sac-TMT 5 mg/kg Q2W or ICC (eribulin, vinorelbine, capecitabine, or gemcitabine)...Grade ≥ 3 TRAEs occurred in 62.0% and 64.8% of pts in sac-TMT and ICC with the most common being neutrophil count decreased (44.5% vs 51.5%) and WBC decreased (31.0% vs 31.6%); TRAE led to discontinuation in 0% and 0.5% of pts; pneumonitis occurred in 1.5% and 1.0% of pts (all grade 1-2) in sac-TMT and ICC, respectively. Conclusions Sac-TMT demonstrated significantly improved PFS compared to ICC, with manageable safety profile in pts with previously treated HR+/HER2- BC including both HER2-zero and HER2-low, positioning it as a new therapeutic option for..."
Clinical • Late-breaking abstract • Metastases • P3 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Hormone Receptor Positive Breast Cancer • Oncology • Solid Tumor • HER-2
October 04, 2025
Minimal important differences in the EORTC QLQ-C30 and QLQ-BR23 for metastatic breast cancer patients in a Japanese population: Results from a randomized trial
(ESMO Asia 2025)
- "Between June 2016 and October 2019, 302 female patients with HER2-negative metastatic breast cancer were enrolled across 50 institutions and randomized to receive either eribulin or S-1... This study identified MIDs for the QLQ-C30 and QLQ-BR23 in Japanese patients with metastatic breast cancer. These findings may help clinicians and researchers in interpreting changes in QOL scores."
Clinical • Metastases • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • ER • HER-2
January 02, 2026
A Phase 2 Study of the Eribulin in Patients with Metastatic Angiosarcoma and Epithelioid Hemangioendothelioma (EHE).
(PubMed, Clin Cancer Res)
- "Eribulin showed clinical activity in this largely taxane-pretreated population. Future studies will be needed to confirm activity."
Journal • P2 data • Angiosarcoma • Oncology • Sarcoma • Solid Tumor
October 31, 2025
Tbcrc 058: a randomized phase 2 study of enzalutamide, enzalutamide with mifepristone, and treatment of physician's choice in patients with androgen receptor-positive metastatic triple-negative or estrogen receptor-low breast cancer (nct06099769)
(SABCS 2025)
- P2 | " This is a randomized phase II trial; 201 patients (pts) will be randomized in a 1:1:1 fashion to enza, enza plus mif, or TPC (carboplatin, paclitaxel, eribulin, or capecitabine). Pts must have normal organ function and no history of brain mets. As of 7/9/2025, 19 of 201 pts have begun protocol-specified tx."
Clinical • IO biomarker • Metastases • P2 data • Breast Cancer • HER2 Breast Cancer • HER2 Negative Breast Cancer • HER2 Positive Breast Cancer • Hormone Receptor Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • AR • CTCs • ER • HER-2 • PGR
March 21, 2026
Long-term outcomes of eribulin‑based neoadjuvant chemotherapy for triple‑negative breast cancer patients stratified by homologous recombination deficiency status: results of the randomized JBCRG-22 study.
(PubMed, Breast Cancer Res Treat)
- P | "These findings will help guide the development of eribulin-based neoadjuvant chemotherapy for selected TNBC patients. Our exploratory analysis of LC and NLR results may help inform clinical prediction models for eribulin-treated patients."
Clinical • Journal • Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • BRCA • HRD
March 13, 2026
A Cancer Vaccine (STEMVAC) in Combination With Chemotherapy for the Treatment of PD-L1 Negative Metastatic Triple-Negative Breast Cancer
(clinicaltrials.gov)
- P2 | N=20 | Recruiting | Sponsor: University of Washington | Not yet recruiting ➔ Recruiting
Enrollment open • Breast Cancer • HER2 Breast Cancer • Oncology • Solid Tumor • Triple Negative Breast Cancer • ENG • ER • HER-2 • PD-L1 • PGR
March 18, 2026
GQ1035: First-in-class ADC against novel targets for gastric cancer and ovarian cancer discovered via high-throughput screening
(AACR 2026)
- "In this screen, TopoIi-ADC and Exatecan-ADC demonstrated superior anti-tumor activity compared to other payload-based ADCs (e.g., DXd, MMAE, Eribulin). GQ1035 shows a promising efficacy profile against gastric and ovarian cancers in preclinical PDO and PDX models. This positions GQ1035 as a potential breakthrough therapy in an area of high unmet medical need. It stands as a pioneering example of the strategic shift in biomedicine from "by design" to "by screening"."
ADC • Gastric Cancer • Oncology • Ovarian Cancer • Solid Tumor • CLDN18 • FOLR1
March 17, 2026
SWOG S1937: Comparing the New Anti-cancer Drug Eribulin With Chemotherapy Against the Usual Chemotherapy Alone in Metastatic Urothelial Cancer
(clinicaltrials.gov)
- P3 | N=184 | Active, not recruiting | Sponsor: National Cancer Institute (NCI) | Recruiting ➔ Active, not recruiting
Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer
March 18, 2026
ACSL4 mediated ferroptosis and its potential role in enhancing the efficacy of antibody-drug conjugates
(AACR 2026)
- "This study investigated whether ADC conjugation can fundamentally reprogram payload pharmacology and clarified the downstream consequences for antitumor efficacy and immune activation beyond conventional delivery advantages.Experimental Design: Using MORAb-202, an ADC consisting of the clinically approved eribulin linked to a folate receptor alpha (FRα)-targeting antibody, we performed intratumoral pharmacokinetic/pharmacodynamic (PK/PD) and pharmacometabolomic analyses in xenograft models with varying FRα expression...Therapeutic efficacy was tested as monotherapy and in combination with pembrolizumab in a human peripheral blood mononuclear cells co-implantation model. ADC-conjugated eribulin achieved >20-fold higher intratumoral retention of eribulin compared to the free eribulin in AUC value... ADC conjugation reprograms payload's pharmacodynamics, inducing ferroptosis and ICD unattainable with free payload, even at clinically equivalent doses. This highlights..."
ADC • Clinical • IO biomarker • Oncology • ACSL4 • FOLR1 • GPX4 • HMGB1
February 18, 2026
AT148009: A Study of Evorpacept (ALX148) in Patients with Metastatic HER2-Positive Breast Cancer
(clinicaltrialsregister.eu)
- P1/2 | N=36 | Not yet recruiting | Sponsor: Alx Oncology Holdings Inc.
New P1/2 trial • Breast Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Oncology • Solid Tumor • HER-2
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