Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Neoplasm Metastasis

Carcinoma

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Vinorelbine

Tubulin Modulators

Antimitotic Agents

50mg three times weekly on Mondays (or Tuesdays), Wednesdays (or Thursdays) and Friday (or Saturdays). A cycle is a 3 weeks period.

60mg/m2 weekly for cycle 1 and 80mg/m2 weekly for subsequent cycles in the absence of grade 3 or 4 toxicity. A cycle is a 3 weeks period.

Oral NVB Metronomic

60mg/m2 weekly for cycle 1 and 80mg/m2 weekly for subsequent cycles in the absence of grade 3 or 4 toxicity. A cycle is a 3 weeks period

Oral NVB Weekly

Binghe Xu, MD

Fei Ma, MD

This is a randomized, open-label, parallel, multi-center study, aims to evaluate the efficacy and safety of metronomic chemotherapy with oral Navelbine versus intermittent oral Navelbine in female patients with HER2 negative Metastasis Breast Cancer.

1. The significant efficacy and good safety profile of Vinorelbine in the treatment of advanced breast cancer are accepted.
2. Oral NVB presents absolute bioavailability of 40% and oral availability allows to use different schedules and the endothelial cell functionality and motility are interfered at very low drug concentration
3. Oral NVB at 50 mg three times a week (Monday-Wednesday-Friday) has been tested in phase Ia/Ib/II trials, highlighting the excellent safety of this scheme combined with an interesting activity in various European countries.
4. The study aims to evaluate the efficacy and safety of metronomic chemotherapy with oral Navelbine versus intermittent oral Navelbine in female patients with HER2 negative Metastasis Breast Cancer.

A Study to Evaluate the Efficacy and Safety of Oral Navelbine in Female Patients With HER2-Negative Metastatic Breast Cancer

A Randomized, Open-label, Parallel Study to Evaluate the Efficacy and Safety of Oral Navelbine in Female Patients With HER2-Negative Metastatic Breast Cancer

Disease Control Rate (DCR) is the proportion of subjects who have best overall response of CR + PR + SD with duration of ≥6 weeks.

Time to Tumor Progression (TTP) is defined as the time from randomization to time of progressive disease.

Time to Treatment Failure (TTF) is defined as the time from randomization to treatment discontinuation for any reason, including disease progression, treatment toxicity, patient toxicity, patient preference, or death.

Progression free survival (PFS) is the time from the date of randomization to the date of first documentation of disease progression, or to the date of death from any case, whichever occurs first.

Overall survival (OS) will be measured from the date of randomization until the date of death from any case.

Adverse events including Serious AEs and non-serious AEs (since ICF signed and until 30 days after last intake of study medication)

The FACT-B +4 (Version 4) (Appendix ) QoL questionnaires will be filled in at baseline before randomization, then every 6 weeks during the Randomization Treatment Period and at EoTV. Changes of the scores from baseline of the parameters will be provided from baseline.

Chinese Academy of Medical Sciences

Professor

Neoplastic Processes

Gastrointestinal Agents

Docetaxel

Cisplatin

Esomeprazole

Proton Pump Inhibitors

Antacids

Anti-Ulcer Agents

Enzyme Inhibitors

docetaxel and cisplatin chemotherapy combined with PPI 160mg per day.

docetaxel and cisplatin chemotherapy combined with PPI 200mg per day.

Docetaxel and cisplatin chemotherapy combined with high dose PPI. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.PPI 200mg p.o. d1-3 every week for 66 weeks.

Arm C

Docetaxel and cisplatin chemotherapy combined with lower dose PPI. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.PPI 160mg p.o. d1-3 every week for 66 weeks.

Arm B

Docetaxel and cisplatin chemotherapy. Docetaxel 75mg/m2 intravenous d1, cisplatin 75mg/m2 intravenous d1,repeated every 3 weeks.Each patient is designed to receive no more than 6 cycles of chemotherapy.

Arm A

XiChun Hu, MD,Ph. D

Antonio Chiesi

Stefano Fais, MD PHD

The objectives of this study are to evaluate the efficacy and tolerability of high dose proton pump inhibitor combined with chemotherapy in metastatic breast cancer.

High dose proton pump inhibitor (PPI) has been proved beneficial and it improved efficacy when combined with chemotherapy in preclinical and clinical trials.This study was designed to explore whether adding a proton pump inhibitor into docetaxel and cisplatin chemotherapy improves efficacy and does not affect tolerability in metastatic breast cancer.

Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer

Phase II Study of Docetaxel and Cisplatin Chemotherapy Versus Docetaxel and Cisplatin Chemotherapy Combined With High Dose Proton Pump Inhibitor in Metastatic Breast Cancer

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study to Evaluate the Efficacy and Safety of Oral Navelbine in Female Patients With HER2-Negative Metastatic Breast Cancer	NCT03854617	Human Epidermal...	Oral NVB Metron... Oral NVB Weekly	18 Years - 85 Years	ChineseAMS
Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer	NCT01069081	Breast Cancer Metastasis, Neo...	Arm C Arm B Arm A	18 Years -	Fudan University
Docetaxel and Cisplatin Chemotherapy With or Without High Dose Proton Pump Inhibitor in Metastatic Breast Cancer	NCT01069081	Breast Cancer Metastasis, Neo...	Arm C Arm B Arm A	18 Years -	Fudan University

Spots Global Cancer Trial Database for metastasis breast cancer