Ignite Creation Date:
2025-12-24 @ 3:55 PM
Ignite Modification Date:
2026-01-01 @ 2:27 PM
Study NCT ID:
NCT03007992
Status:
COMPLETED
Last Update Posted:
2019-08-12
First Post:
2016-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/Metastatic Hormone Receptor Positive (HR+)/Human Epidermal Growth Factor Receptor 2 Negative (HER2-) Breast Cancer
Sponsor:
Johannes Gutenberg University Mainz
Organization:
Study Overview
Official Title:
Phase II Study of Metronomic Treatment With Daily Oral Vinorelbine as First-line Chemotherapy in Patients With Advanced/Metastatic HR+/HER2- Breast Cancer Resistant to Endocrine Therapy
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VinoMetro
Brief Summary:
The purpose of the trial is to investigate the efficacy of metronomic treatment with daily oral vinorelbine in terms of clinical benefit rate based on local radiological assessment in patients with advanced/metastatic HR+/HER2- breast cancer resistant to endocrine therapy.
Detailed Description:
In terms of the chronic nature of advanced/metastatic breast cancer, there is a high medical need for new treatment options after failure of hormonal treatment that prolong the interval to the start of intensive cytotoxic therapy, which is commonly associated with impaired quality of life (QoL) and potentially serious side effects. In this respect, metronomic treatment with daily administration of oral vinorelbine could provide an efficacious treatment option with limited toxicities.
Accordingly, this national, multi-centre, open-label, single-arm phase II trial aims to investigate a truly metronomic schedule with daily oral vinorelbine in HR+/HER2-patients with metastatic breast cancer resistant to endocrine therapy, by assessing efficacy and safety. Oral vinorelbine will be administered at a daily dose of 30 mg (flat dose without any adaptation to body weight or body surface area) without breaks. Treatment will continue until disease progression, occurrence of unacceptable toxicity, patient's refusal or investigator's decision to stop the treatment.
In the course of the study, the following interim and final analyses will be done:
i) 1st interim analysis (safety): This analysis will be performed on the basis of 10 patients, who were initially included into the study and who are eligible for safety evaluation; frequency statistics of (serious) adverse events will be analysed.
ii) 2nd interim analysis (efficacy): This analysis will be performed at the completion of the 1st Simon stage.
iii) Final analysis (complete): This analysis will be performed after completion of the follow-up phase (6 months of follow-up after Last Patient Last Treatment).
Accordingly, this national, multi-centre, open-label, single-arm phase II trial aims to investigate a truly metronomic schedule with daily oral vinorelbine in HR+/HER2-patients with metastatic breast cancer resistant to endocrine therapy, by assessing efficacy and safety. Oral vinorelbine will be administered at a daily dose of 30 mg (flat dose without any adaptation to body weight or body surface area) without breaks. Treatment will continue until disease progression, occurrence of unacceptable toxicity, patient's refusal or investigator's decision to stop the treatment.
In the course of the study, the following interim and final analyses will be done:
i) 1st interim analysis (safety): This analysis will be performed on the basis of 10 patients, who were initially included into the study and who are eligible for safety evaluation; frequency statistics of (serious) adverse events will be analysed.
ii) 2nd interim analysis (efficacy): This analysis will be performed at the completion of the 1st Simon stage.
iii) Final analysis (complete): This analysis will be performed after completion of the follow-up phase (6 months of follow-up after Last Patient Last Treatment).
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: