Triple-Negative Breast Cancer
Conditions
Brief summary
The study is being conducted to evaluate VEGFR BP102 with nab-paclitaxe or treatment of physician's choice (TPC) versus nab-paclitaxe or TPC in patients for basal-like immune suppressed (BLIS) subtype of triple-negative breast cancer (TNBC) in the first-line teatment of unresectable locally advanced or metastatic TNBC.
Interventions
DRUGVEGFR and TPC
VEGFR and TPC If patients were de novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to experimental arm: VEGFR bevacizumab 10mg/kg d1,15 ivgtt + nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine with bevacizumab maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks and bevacizumab 10mg/kg d1,15 ivgtt every 4 weeks. If patients' DFI were less than 12 months and were randomized to experimental arm: VEGFR bevacizumab 10mg/kg d1,15 ivgtt, every 4 weeks, + TPC (eribulin mesylate 1.4mg/m2 d1,8 iv, every 3 weeks / vinorelbine 25 mg/m2 d1,8 ivgtt , every 3 weeks/ capecitabine 1000mg/m2 po bid d1-d14 every 3 weeks /carboplatin AUC=6 d1 ivgtt, every 3 weeks / UTD1 30mg/m2 d1-5 ivgtt, every 3 weeks ).
DRUGTPC
If patients were de novo or their disease-free interval (DFI) were more than or equal to 12 months and were randomized to control arm: nab-paclitaxel 100mg/m2 d1,8,15 ivgtt, 4 weeks as a cycle. Capecitabine maintenance if intolerable toxicity was observed with no progression. Capecitabine maintenance 1000mg/m2 po bid d1-d14 every 3 weeks. If patients' DFI were less than 12 months and were randomized to control arm: TPC (eribulin mesylate 1.4mg/m2 d1,8 iv, every 3 weeks / vinorelbine 25 mg/m2 d1,8 ivgtt , every 3 weeks/ capecitabine 1000mg/m2 po bid d1-d14 every 3 weeks /carboplatin AUC=6 d1 ivgtt, every 3 weeks / UTD1 30mg/m2 d1-5 ivgtt, every 3 weeks ).
Sponsors
Fudan University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* ECOG Performance Status of 0-1 * Expected lifetime of not less than three months * Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression) with BLIS subtype * Cancer stage: recurrent or metastatic breast cancer; Local recurrence be confirmed by the researchers could not be radical resection * Patients had received no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer * At least one measurable or non-measurable lesion according to Response Evaluation Criteria in Solid Tumors v1.1 (RECIST v1.1), which didn't receive radiation therapy * The functions of major organs are basically normal * For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures as outlined for each specific treatment arm * Have the cognitive ability to understand the protocol and be willing to participate and to be followed up
Exclusion criteria
* Symptomatic, untreated, or actively progressing CNS metastases * Significant cardiovascular disease * Adverse reactions of Grade ≥1 that are still continuing due to previous treatments. Exceptions are those of hair loss or which researchers take it as exception * Major surgery was performed within 3 weeks of the first course of trial treatment (except for minor outpatient surgery, such as placement of vascular access) * Pregnancy or breastfeeding, or intention of becoming pregnant during the study * Other malignancies within 5 years, excluding cured cervical carcinoma in situ, skin basal cell carcinoma, or skin squamous cell carcinoma * Inability to swallow, chronic diarrhea and intestinal obstruction, there are multiple factors that affect the use and absorption of drugs * Presence of third-space fluid accumulation that cannot be controlled by drainage or other methods (such as excessive pleural fluid and ascites) * Participated in clinical trials of other antitumor drugs within 4 weeks before first taking the investigational drug * Long-term unhealing wound or incomplete healing of fracture * Patients with known active HBV or HCV infection or hepatitis B DNA≥500, or chronic phase with abnormal liver function * Allergic constitution, or known allergic history of the drug components of this trial; Or allergic to other monoclonal antibodies * Patients with a history of gastrointestinal bleeding or a clear tendency to gastrointestinal bleeding within the past 6 months, such as esophageal varicose veins with bleeding risk, locally active ulcer lesions, stool occult blood ≥ (++), were not allowed to enter the group; If there is occult blood in the stool (+), gastroscopy is required * Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this trial * Urine protein ≥2+ and 24h urine protein quantitative \> 1.0 g * Patients suffering from hypertension and unable to reach the normal range after antihypertensive drug treatment (systolic blood pressure \>140mmHg, diastolic blood pressure \>90mmHg)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PFS | Randomization until the first occurrence of disease progression or death from any cause, which ever occurs first, through the end of study (approximately 1.5 years) | time to progressive disease (according to RECIST1.1) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ORR | max 6 months | The proportion of participants whose best outcome is complete remission or partial remission (according to RECIST1.1) |
| DoR | max 6 months | Duration of Overall Response.The date of the first assessed PR/CR (according to RECIST 1.1) to the date of the first assessed tumor progression (according to RECIST 1.1) or death from any cause. |
| DCR | max 6 months | The percentage of subjects with CR+PR+SD and last more than 4 weeks in all of the participants with measurable lesions. |
| OS | approximately 3 years | Time to death due to any cause |
| Safety and tolerability | Approximately 3 years | Adverse events according to NCI-CTCAE Version 5.0 per each treatment arm |
| Score of patient reported outcome (PRO) | Approximately 3 years | Score of questionnaire by a report directly from a patient about his or her health or life quality. |
| Exploratory biomarkers | Approximately 3 years | The collected subjects' tumor tissues, paracancerous tissues, blood, and fecal samples will be used for discovering exploratory biomarkers. |
Countries
China
Contacts
CONTACTZhimin Shao
Outcome results
None listed