Combined Use of Apatinib Mesylate and Vinorelbine Versus Single Use of Vinorelbine in Triple-negative Breast Cancer

NCT03932526 | Unknown Phase 2 DMC

• 1 other identifier: STao-003
• Study Type: interventional
• Target: 184
• Locations: 0 countries
• Sites: N/A

Brief Summary

To compare the therapeutic effect of vinorelbine used alone or combined with apatinib mesylate for recurrent or metastatic TNBC patients who have at least received one chemotherapy regimen, including anthracyclines and taxanes, providing clinical evidence for multi-line treatment options for advanced TNBC.

Conditions

Triple-negative Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progress-Free Survival(PFS)

  PFS refers to the length of time from random enrollment to any recorded tumor progression or death from any cause.

  Day 1 of treatment until disease progression or death from any cause, assessed up to 24 months

Secondary Outcomes (4)

• Overall survival (OS)

  Up to 24 months

• Disease control rate (DCR)

  Up to 24 months

• Overall remission rate (ORR)

  Up to 24 months

• Adverse events at levels 3 and 4

  every 6 weeks (two cycles) and 4 weeks after treatment discontinuation

Study Arms (2)

Vinorelbine + placebo group

ACTIVE COMPARATOR

92 enrolled patients will be assigned to receive oral vinorelbine plus placebo until disease progression or other criteria for administration termination.

Drug: Vinorelbine + placebo

Vinorelbine + Apatinib group

EXPERIMENTAL

92 enrolled patients will be assigned to receive oral patatinib mesylate in combination with vinorelbine until disease progression or other criteria for administration termination.

Drug: Vinorelbine + Apatinib

Interventions

Vinorelbine + placebo DRUG

Combined administration of vinorelbine and placebo. Based on oral administration of vinorelbine, the patients will be given oral placebo (starch as an ingredient). The placebo appearance, including shape, size, color and weight, taste, labeling and packing are the same with those of apatinib mesylate tablets.

Also known as: AiTan+ placebo

Vinorelbine + placebo group

Vinorelbine + Apatinib DRUG

Combined administration of vinorelbine and apatinib. Vinorelbine tartrate soft capsule (also named Navelbine; registration No. H20140657; Pierre Fabre Medicament, Boulogne, France) 40 mg once orally, taken in the morning (at least 1 hour before or at least 1 hour after meals), three times a week (Mondays, Wednesdays, and Fridays), for a continuous 21-day cycle. Apatinib mesylate tablets (also named Aitan, State Medical Permission No. H20140103; Jiangsu Hengrui Pharmaceutical Co., Ltd., China), 500 mg orally, taken once a day for a continuous 21-day cycle.

Also known as: Navelbine+AiTan

Vinorelbine + Apatinib group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients with recurrent or metastatic TNBC, as confirmed by histological or cytological examination
• Age 18-70 years old
• According to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1, there is at least one measurable lesion.
• The Eastern Cooperative Oncology Group (ECOG) scores 0-2
• Expected survival ≥ 12 weeks
• Negative for ER/PR
• All patients will be tested for bone marrow capacity, liver and renal functions within 7 days prior to enrollment
• Previous use of anthracyclines and/or taxanes
• The medication history of vinorelbine
• Female patients of childbearing age must take adequate contraception; otherwise the patients must be proven to be infertile
• No history of serious heart, lung, liver, and kidney diseases
• Provision of written informed consent

You may not qualify if:

• Patients who receive chemotherapy, radiation therapy, targeted drugs, or hormone therapy within 3 weeks of administration
• Patients using corticosteroids for untreated brain or subdural metastatic lesions, need to have stopped it, at least for 4 weeks or until there are no signs of brain metastasis and/or symptoms must have stabilized for at least 4 weeks, if local treatment has been completed. Enhanced computed tomography (CT) or magnetic resonance imaging (MRI) images during screening are compared with those performed at least 4 weeks earlier to determine radiological stability.
• Patients with severe vascular diseases, including unstable angina, myocardial infarction, or severe arrhythmia in the past 6 months
• History of HIV infection or active chronic hepatitis B or C
• Patients with other serious infectious diseases
• Patients positive for ER/PR/HER-2 positive
• Patients with allogeneic organ transplants requiring immunosuppressive therapy
• History of other malignant tumors within 5 years, except for cured cervical carcinoma in situ or basal cell carcinoma of the skin
• Other destabilizing factors that may interfere with patients or have an impact on the trial results
• Allergic to target drugs or allergic to related drugs applied in the trial
• Pregnant or lactating women

Sponsors & Collaborators

• Liaoning Cancer Hospital & Institute: lead

Related Publications (1)

• Wu S, Zhang L, Li H, Xu J, Jiang C, Sun T. Combined use of apatinib mesylate and vinorelbine versus vinorelbine alone in recurrent or metastatic triple-negative breast cancer: study protocol for a randomized controlled clinical trial. Trials. 2020 May 24;21(1):420. doi: 10.1186/s13063-020-04342-x.

  PMID: 32448335 DERIVED

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Vinorelbine; apatinib

Condition Hierarchy (Ancestors)

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines

Study Officials

• Tao Sun

  Liaoning Cancer Hospital & Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tao Sun, M.D.

CONTACT

86-024-31986682; jianong@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department director

Study Record Dates

• First Submitted: April 15, 2019
• First Posted: April 30, 2019
• Study Start: June 24, 2019
• Primary Completion: December 12, 2022
• Study Completion: June 26, 2023
• Last Updated: April 30, 2019

Record last verified: 2019-04