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

Respiratory Tract (Lung and Bronchial) Diseases

Carcinoma, Non-Small-Cell Lung

Lung Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

chemotherapy

Radiation

Paul Schwarzenberger, MD

The study is designed for subjects whose cancer is too advanced and therefore cannot be operated with the goal of completely removing the cancer. At this stage of the disease, most subjects cannot be cured from the disease, however, treatment can help subjects to live longer and better by keeping the cancer under control. All treatment offered to is primarily pursuing that goal. Subjects at this stage of their disease traditionally receive radiation therapy or chemotherapy, both treatments in succession or both concurrently. Recently, the administration of both methods of treatment concurrently has been employed and indicate somewhat better results. Specifically, a class of chemotherapy agents called Vinca Alakaloids used in combination with radiation therapy appear promising as determined in small studies. The drug Navelbine is part of this class of drugs. This drug is approved as an infusion through the veins. The pill form is under development and will be used in this form in this treatment program.

For this protocol, radiation will be administered using a schedule which is more convenient for patients, by once weekly chest irradiation for a total of 12 weeks. Use of this schedule was determined to be as good as the more commonly used daily radiotherapy. The once weekly schedule is less cumbersome as it involves less visits. The rationale and reason why you are being asked to participate in this program is to study whether the drug Navelbine can be given together with the once weekly radiation schedule. Radiation will be administered in two fractions, 6 hours apart on one day. For this program, the drug Navelbine would be made available as a pill, and would not have to be infused through the vein. The proposed protocol will use increasing doses of the drug Navelbine in pill form to find the highest dose of Navelbine that is tolerated in conjunction with radiation therapy. Initially, each subject will receive one dose of Navelbine, which is higher than the dose of the previous subject. This escalation will continue until the highest tolerated dose has been determined.

The administration via pill would be easier and avoid previously experienced side effects that were experienced by infusion into the veins of subjects, such as burning and sores at the infusion site.

35 patients with advanced NSCLC will be enrolled (stages III and IV) and treated once per week in two fractions for a total of 12 cycles using a previous prescription developed by Salazar et al to a total of 6000 rad.

Treatment will be given to a large field with a 2-3 cm tumor margin. All involved or suspicious nodal areas will be radiated as well. The drug Navelbine will be given in a dose escalation on the same day the radiation is administered. The starting dose for Navelbine will be 20 mg/m2 and the escalation will be in 10 mg increments.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
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
Combination of Weekly Chest Radiotherapy and Oral Navelbine for the Palliation of Advanced Non Small Cell Lung Cancer: A Phase I Study	NCT00256815	Carcinoma, Non-...	chemotherapy Radiation	-	Clinical Oncology Research Associates

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