Navelbine oral (vinorelbine tartrate oral)

Low-dose apatinib combined with oral vinorelbine demonstrates potential efficacy and well tolerated for pretreated HER2-negative mBC.

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

P3, N=118, Recruiting, Children's Oncology Group | Trial completion date: Dec 2027 --> Sep 2027 | Trial primary completion date: Dec 2027 --> Sep 2027

P2, N=140, Completed, ETOP IBCSG Partners Foundation | Active, not recruiting --> Completed

In this randomized phase II trial, single-agent metronomic oral vinorelbine was effective and well tolerated as first-line chemotherapy for patients with HR-positive/HER2-negative ABC. Formal comparisons are not done in this phase II study and one can simply observe that confidence intervals of all endpoints overlap. When deciding for a chemotherapy after failure of endocrine therapy and CDK 4/6 inhibitors, oral vinorelbine might be an option to be given with either schedule.

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

Human epidermal growth factor receptor 2 (HER2)-targeted agents have significantly improved the outcomes of patients with HER2-positive breast cancer; however, a large proportion of patients still develop resistance to trastuzumab. The combination regimen of inetetamab, pyrotinib, and oral vinorelbine showed encouraging efficacy and favorable safety in patients with HER2-positive advanced breast cancer and could be considered as an alternative treatment option for the patients. No.NCT05823623; https://www.clinicaltrials.gov/.

P2, N=182, Not yet recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

P1/2, N=100, Recruiting, St. Jude Children's Research Hospital | Not yet recruiting --> Recruiting | Initiation date: Nov 2023 --> Feb 2024

P1/2, N=34, Active, not recruiting, Eli Lilly and Company | Trial completion date: Jan 2024 --> Apr 2024 | Trial primary completion date: Oct 2023 --> Apr 2024

P=N/A, N=60, Recruiting, Xi'an International Medical Center Hospital; Xi'an International Medical Center Hospital

P4, N=30, Not yet recruiting, Beijing Hospital; Beijing Hospital

P3, N=453, Completed, Hoffmann-La Roche | Active, not recruiting --> Completed

In this prospective, single-arm, phase 2 trial, patients with HER2-positive metastatic breast cancer after progression on trastuzumab were recruited. The combination regimen of inetetamab plus pyrotinib plus oral vinorelbine showed an encouraging efficacy and favorable safety in patients with HER2 positive metastatic breast cancer.

The VEX regimen may provide more prolonged disease control than weekly paclitaxel for ER+/ERBB2- MBC. ClinicalTrials.gov Identifier: NCT02954055.

P2, N=30, Recruiting, The First Affiliated Hospital with Nanjing Medical University | Initiation date: Sep 2022 --> Feb 2022

P1/2, N=100, Not yet recruiting, St. Jude Children's Research Hospital

P=N/A, N=60, Recruiting, Yan Xue

The dual oral mNC regimen showed very good safety features and improved compliance without loss of efficacy in both first- and second-line treatments. The regimen also reached an excellent ORR in the mTNBC subgroup.

First-line treatment with atezolizumab monotherapy was associated with improved overall survival, a doubling of the 2-year survival rate, maintenance of quality of life, and a favourable safety profile compared with single-agent chemotherapy. These data support atezolizumab monotherapy as a potential first-line treatment option for patients with advanced NSCLC who are ineligible for platinum-based chemotherapy.

Osimertinib continuation in conjunction with metronomic oral vinorelbine may enable overcoming TKI resistance and prolong the survival of patients with EGFR-mutant advanced NSCLC beyond limited progression on osimertinib treatment.

P2, N=162, Recruiting, European Institute of Oncology | Unknown status --> Recruiting | Trial completion date: Dec 2020 --> Dec 2023 | Trial primary completion date: Dec 2020 --> Dec 2023

P2, N=500, Recruiting, University of Miami | Not yet recruiting --> Recruiting

We present a novel study of MMT with oral vinorelbine and continuous low doses of cyclophosphamide in real-world pediatric patients with RMS. Our findings showed that the MMT strategy significantly improved patient outcomes and may be an effective treatment for high-risk and relapsed patients.

P3, N=453, Active, not recruiting, Hoffmann-La Roche | Trial completion date: Mar 2023 --> Jul 2023

This is the first exploratory study of a fulvestrant and oral vinorelbine regimen in the treatment of HR+/HER2- recurrent and metastatic breast cancer. The combination chemo-endocrine therapy was efficacious, safe, and promising for patients with HR+/HER2- advanced breast cancer.

P2, N=30, Recruiting, The First Affiliated Hospital with Nanjing Medical University

NerHer has been designed as a phase II clinical study to evaluate the efcacy of neratinib and trastuzumab +/– oral vinorelbine in pretreated patients with metastatic HER2 positive breast cancer. Pretreatment will include trastuzumab emtansine and/or T-Dxd and/or tucatinib in combination with trastuzumab and capecitabine...Implementation of the escalation dosing of neratinib over the frst 3 weeks of therapy may diminish the rate of diarrhea. Cellfree DNA will be longitudinally collected at prespecifed time points, and potential resistance mechanisms evaluated.

Metronomic oral vinorelbine-atezolizumab in the second-line setting did not achieve the predefined PFS threshold. No new safety signal was reported for vinorelbine-atezolizumab combination.

The most common grade 3/4 AEs included neutropenia (10.3%) and nausea/vomiting (6.9%). Conclusions A doublet metronomic chemotherapeutic regimen with oral mNC is a well-tolerated and effective anti-tumor regimen for HER2-negative MBC in China.

The addition of AI to oral vinorelbine over oral vinorelbine alone in aromatase inhibitor-resistant metastatic breast cancer was associated with a non-significant improvement of PFS. Several unexpected serious adverse events were reported. Metronomic oral vinorelbine schedule, at 50 mg three times a week, requires close biological monitoring. The question of hormonal treatment and chemotherapy combination remains open.

P2, N=30, Recruiting, Cancer Institute and Hospital, Chinese Academy of Medical Sciences

P=N/A, N=40, Not yet recruiting, Fujian Cancer Hospital

Conclusion This is the first exploratory study of Fulvestrant with oral Vinorelbine regimen in the treatment of HR+/HER2− recurrent and metastatic breast cancer conducted worldwide. The combinative chemo- endocrine therapy was efficacious, safe and promising for patients with HR+/HER2− advanced breast cancer.

P2, N=140, Active, not recruiting, ETOP IBCSG Partners Foundation | Trial completion date: Mar 2022 --> Dec 2022 | Trial primary completion date: Dec 2021 --> Dec 2022

Pembrolizumab (an anti- PD1) has been FDA-approved in MSI-h/TMB-h advanced solid tumor (AST) with an agnostic indication. Table: 478P Conclusions T+D+MOV has promising activity in TMB-h and or MSI-h cohort. Toxicity profile was consistent with previous reports of T+D combination or MOV.

Three pts died during treatment (1 P; 2 VEX). Conclusions METEORA-II trial showed VEX significantly improved TTF compared with P. VEX metronomic oral treatment should be considered as a first-line CT regimen for pts with ER+/HER2- MBC that require CT.

Beyond canonical BSA and leukocytes, ABCB1-rs2032582 polymorphism showed a meaningful impact on VNR systemic exposure. Simulations showed that the identified covariates could have an impact on both efficacy and toxicity outcomes. Thus, a personalized dosing strategy, using those covariates, could help to optimize the efficacy/toxicity balance of VNR in children.

Pyrotinib combined with metronomic oral vinorelbine showed promising efficacy and manageable safety in patients with HER2-positive advanced breast cancer who had failed prior trastuzumab-based therapy. This study might represent a potential treatment option for these patients.

Higher doses may be necessary for children with LGG. A personalized dosing strategy, using BSA, leukocytes and ABCB1-rs2032582 SNP, could help to optimize the efficacy/toxicity balance of VNR in children. Model-informed drug development enabled efficiently a better understanding of PK of oral VNR in children and identifying several factors likely to explain the variability in VNR exposure and subsequent clinical outcomes.

P1/2, N=150, Active, not recruiting, UNICANCER | Trial primary completion date: Jan 2022 --> May 2022

P3, N=300, Recruiting, Spanish Breast Cancer Research Group | Not yet recruiting --> Recruiting