Triple-negative Breast Cancer Clinical Trial
Official title:
Combined Use of Apatinib Mesylate and Vinorelbine Versus Single Use of Vinorelbine in Recurrent or Metastatic Triple-negative Breast Cancer: a Double-blinded Randomized Controlled Clinical Trial
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.
Status | Not yet recruiting |
Enrollment | 184 |
Est. completion date | June 26, 2023 |
Est. primary completion date | December 12, 2022 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - 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 Exclusion Criteria: - 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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Liaoning Tumor Hospital & Institute |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Overall survival (OS) | OS indicates the length of time from enrollment to death from any cause.When no information on death is collected in the clinical database, the last date when the patient is still known to have survived is used as the cut-off point. | Up to 24 months | |
Secondary | Disease control rate (DCR) | DCR indicates the percentage of patients with CR, partial remission, and disease stabilization; and maintenance over 4 weeks, accounts for all the subjects with evaluable efficacy. | Up to 24 months | |
Secondary | Overall remission rate (ORR) | ORR is the proportion of patients who achieve a complete or partial response ((CR+PR)/total number of cases x 100%), as assessed by the RECIST v1.1. | Up to 24 months | |
Secondary | Adverse events at levels 3 and 4 | Patients with adverse events at levels 3 and 4 will be assessed according to the National Cancer Institute Common Toxicity Criteria (NCI-CTC) Version 4.0. | every 6 weeks (two cycles) and 4 weeks after treatment discontinuation |
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