Back to resultsPrecise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer
Triple-Negative Breast Cancer
About this trial
This is an interventional treatment trial for Triple-Negative Breast Cancer
Eligibility Criteria
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) 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 Active hepatitis B or hepatitis C History of malignancy other than breast cancer within 5 years prior to screening, with the exception of those with a negligible risk of metastasis or death Pregnancy or breastfeeding, or intention of becoming pregnant during the study History of gastrointestinal bleeding within 6 months or any serious bleeding events Abdominal fistula, gastrointestinal perforation or abdominal abscess occurred within 28 days before participating in this study Long-term unhealing wound or incomplete healing of fracture Urine protein ≥2+ and 24h urine protein quantitative > 1 g Patients suffering from hypertension and unable to reach the normal range after antihypertensive drug treatment (systolic blood pressure >140mmHg, diastolic blood pressure >90mmHg)
Sites / Locations
- Breast cancer institute of Fudan University Cancer HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Experimental
Active Comparator
Experimental
Active Comparator
De novo or DFI≥12m Arm 1
De novo or DFI≥12m Arm 2
DFI<12m Arm 1
DFI<12m Arm 2
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, they would receive VEGFR BP102 with nab-palitaxel (Nab-P).
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, they would receive nab-palitaxel (Nab-P).
If patients' disease-free interval (DFI) were less than 12 months and were randomized to experimental arm, they would receive VEGFR BP102 with treatment of physician's choice (TPC).
If patients' disease-free interval (DFI) were less than 12 months and were randomized to control arm, they would receive physician's choice (TPC).
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
2. Study Status
3. Sponsor/Collaborators
4. Oversight
5. Study Description
6. Conditions and Keywords
7. Study Design
8. Arms, Groups, and Interventions
10. Eligibility
12. IPD Sharing Statement
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