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Study protocol
Tao Sun
Liaoning Cancer Hospital & Institute
Corresponding Author
ORCiD: https://orcid.org/0000-0001-5931-386X
License:
This work is licensed under a CC BY 4.0 License. Read Full License
Background: The emergence of new molecular targeted drugs provides new prospects for the treatment of advanced breast cancer; the future therapeutic trend includes chemotherapy combined with molecular targeted therapy. Apatinib mesylate, a novel, small anti-angiogenic agent, highly selectively inhibits the activity of vascular endothelial growth factor receptor-2 tyrosine kinase. Apatinib mesylate also blocks the signaling of vascular endothelial growth factor binding to its receptor, thereby, strongly inhibiting tumor angiogenesis and exerting an anti-tumor effect. However, a randomized controlled clinical trial of apatinib combined with vinorelbine for triple-negative breast cancer (TNBC) has not been reported. We will compare the therapeutic effect of vinorelbine alone or in combination with apatinib mesylate in patients with recurrent or metastatic TNBC in North China who have received at least two drug treatments including anthracyclines and taxanes.
Methods/analysis: This study is a triple-blind, randomized, placebo-controlled, parallel-group clinical trial. We plan to include 164 female patients with locally recurrent or metastatic TNBC and without BRCA1 mutation (as BRCA-positive patients would have poor responses to the therapeutic methods designed in this study), admitted at the Liaoning Cancer Hospital & Institute, Northeast China. All enrolled patients will be randomized to orally take vinorelbine alone (40 mg orally, thrice a week (Mondays, Wednesdays, and Fridays) in each 3-week cycle) or combined with apatinib mesylate (500 mg orally, once daily of each 3-week cycle). Radiographic assessment will be performed every 6 weeks for 36 weeks, and every 9 weeks thereafter. The primary outcome is measurement of progression-free survival and secondary outcomes include overall survival, disease control rate, objective response rate, and incidence of adverse events at grades 3 and 4 as defined by the National Cancer Institute Common Toxicity Criteria [NCI-CTC] Version 4.0. Outcome measures will be evaluated at baseline (< 2 weeks before starting treatment), every 6 weeks during treatment, and at 4 weeks and every 3 months after treatment discontinuation.
Discussion: Based on the data from this trial, we hope to identify a treatment plan that is suitable for female TNBC patients in Northeast China who have been treated with anthracyclines and taxanes.
Keywords
triple-negative breast cancer, apatinib, vinorelbine, advanced breast cancer, metastatic
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CURRENT STATUS: Published
View the published article at Trials.
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Editorial decision: Accept
On 24 Apr, 2020
Editor assigned
On 10 Apr, 2020
Submission checks complete
On 07 Apr, 2020
No comments provided
Editorial decision: Minor revision
On 24 Mar, 2020
Review #1 received
Received 23 Mar, 2020
Reviewer #1 agreed
On 16 Mar, 2020
Reviewers invited
Invitations sent on 14 Mar, 2020
Editor assigned
On 04 Mar, 2020
Submission checks complete
On 03 Mar, 2020
No comments provided
Editorial decision: Minor revision
On 20 Feb, 2020
Review #1 received
Received 19 Feb, 2020
Reviewer #1 agreed
On 14 Feb, 2020
Reviewers invited
Invitations sent on 13 Feb, 2020
Editor assigned
On 12 Feb, 2020
Submission checks complete
On 11 Feb, 2020
No comments provided
Reviewer #1 agreed
On 16 Jan, 2020
Review #1 received
Received 16 Jan, 2020
Editorial decision: Minor revision
On 16 Jan, 2020
Reviewers invited
Invitations sent on 13 Jan, 2020
Editor assigned
On 06 Jan, 2020
Submission checks complete
On 04 Jan, 2020
Version 2
Posted 19 Nov, 2019
No comments provided
Review #1 received
Received 11 Dec, 2019
Editorial decision: Major revision
On 11 Dec, 2019
Reviewer #1 agreed
On 06 Dec, 2019
Editor assigned
On 14 Nov, 2019
Reviewers invited
Invitations sent on 14 Nov, 2019
Submission checks complete
On 13 Nov, 2019
No comments provided
Editorial decision: Minor revision
On 16 Oct, 2019
Reviewer #1 agreed
On 06 Oct, 2019
Review #1 received
Received 06 Oct, 2019
Reviewers invited
Invitations sent on 12 Sep, 2019
Editor assigned
On 10 Sep, 2019
Submission checks complete
On 19 Jul, 2019
First submitted
On 18 Jul, 2019
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A new preprint design is coming!
We have improved readability, clarity, accessibility, and opportunities for engagement.
See the published version of this preprint at Trials.
This is a preprint, a preliminary version of a manuscript that has not completed peer review at a journal. Research Square does not conduct peer review prior to posting preprints. The posting of a preprint on this server should not be interpreted as an endorsement of its validity or suitability for dissemination as established information or for guiding clinical practice.
Learn more about In Review
Study protocol
Tao Sun
Liaoning Cancer Hospital & Institute
Corresponding Author
ORCiD: https://orcid.org/0000-0001-5931-386X
Badges
Prescreen
This manuscript passed our Prescreen assessment
Complete author information
Appropriate declaration statements
Potential risks to human health
Prescreen
Peer Review Timeline
CURRENT STATUS: Published
View the published article at Trials.
No community comments so far
Editorial decision: Accept
On 24 Apr, 2020
Editor assigned
On 10 Apr, 2020
Submission checks complete
On 07 Apr, 2020
No comments provided
Editorial decision: Minor revision
On 24 Mar, 2020
Review #1 received
Received 23 Mar, 2020
Reviewer #1 agreed
On 16 Mar, 2020
Reviewers invited
Invitations sent on 14 Mar, 2020
Editor assigned
On 04 Mar, 2020
Submission checks complete
On 03 Mar, 2020
No comments provided
Editorial decision: Minor revision
On 20 Feb, 2020
Review #1 received
Received 19 Feb, 2020
Reviewer #1 agreed
On 14 Feb, 2020
Reviewers invited
Invitations sent on 13 Feb, 2020
Editor assigned
On 12 Feb, 2020
Submission checks complete
On 11 Feb, 2020
No comments provided
Reviewer #1 agreed
On 16 Jan, 2020
Review #1 received
Received 16 Jan, 2020
Editorial decision: Minor revision
On 16 Jan, 2020
Reviewers invited
Invitations sent on 13 Jan, 2020
Editor assigned
On 06 Jan, 2020
Submission checks complete
On 04 Jan, 2020
Version 2
Posted 19 Nov, 2019
No comments provided
Review #1 received
Received 11 Dec, 2019
Editorial decision: Major revision
On 11 Dec, 2019
Reviewer #1 agreed
On 06 Dec, 2019
Editor assigned
On 14 Nov, 2019
Reviewers invited
Invitations sent on 14 Nov, 2019
Submission checks complete
On 13 Nov, 2019
No comments provided
Editorial decision: Minor revision
On 16 Oct, 2019
Reviewer #1 agreed
On 06 Oct, 2019
Review #1 received
Received 06 Oct, 2019
Reviewers invited
Invitations sent on 12 Sep, 2019
Editor assigned
On 10 Sep, 2019
Submission checks complete
On 19 Jul, 2019
First submitted
On 18 Jul, 2019
Metrics
Comments: 0
PDF Downloads: ...
HTML Views: ...
License:
This work is licensed under a CC BY 4.0 License. Read Full License
View the published article at Trials.
Background: The emergence of new molecular targeted drugs provides new prospects for the treatment of advanced breast cancer; the future therapeutic trend includes chemotherapy combined with molecular targeted therapy. Apatinib mesylate, a novel, small anti-angiogenic agent, highly selectively inhibits the activity of vascular endothelial growth factor receptor-2 tyrosine kinase. Apatinib mesylate also blocks the signaling of vascular endothelial growth factor binding to its receptor, thereby, strongly inhibiting tumor angiogenesis and exerting an anti-tumor effect. However, a randomized controlled clinical trial of apatinib combined with vinorelbine for triple-negative breast cancer (TNBC) has not been reported. We will compare the therapeutic effect of vinorelbine alone or in combination with apatinib mesylate in patients with recurrent or metastatic TNBC in North China who have received at least two drug treatments including anthracyclines and taxanes.
Methods/analysis: This study is a triple-blind, randomized, placebo-controlled, parallel-group clinical trial. We plan to include 164 female patients with locally recurrent or metastatic TNBC and without BRCA1 mutation (as BRCA-positive patients would have poor responses to the therapeutic methods designed in this study), admitted at the Liaoning Cancer Hospital & Institute, Northeast China. All enrolled patients will be randomized to orally take vinorelbine alone (40 mg orally, thrice a week (Mondays, Wednesdays, and Fridays) in each 3-week cycle) or combined with apatinib mesylate (500 mg orally, once daily of each 3-week cycle). Radiographic assessment will be performed every 6 weeks for 36 weeks, and every 9 weeks thereafter. The primary outcome is measurement of progression-free survival and secondary outcomes include overall survival, disease control rate, objective response rate, and incidence of adverse events at grades 3 and 4 as defined by the National Cancer Institute Common Toxicity Criteria [NCI-CTC] Version 4.0. Outcome measures will be evaluated at baseline (< 2 weeks before starting treatment), every 6 weeks during treatment, and at 4 weeks and every 3 months after treatment discontinuation.
Discussion: Based on the data from this trial, we hope to identify a treatment plan that is suitable for female TNBC patients in Northeast China who have been treated with anthracyclines and taxanes.
Figure 1
Figure 2
This is a list of supplementary files associated with this preprint. Click to download.
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