NCT05806060 Precise Treatment for BLIS Subtype of TNBC in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer
| NCT ID | NCT05806060 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Fudan University |
| Condition | Triple-Negative Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 134 participants |
| Start Date | 2023-04-25 |
| Primary Completion | 2026-05-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 134 participants in total. It began in 2023-04-25 with a primary completion date of 2026-05-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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) 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)
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05806060 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 70 Years, studying Triple-Negative Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05806060 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 134 participants.
Is NCT05806060 currently recruiting?
Yes, NCT05806060 is actively recruiting participants. Contact the research team at zhimingshao@yahoo.com for enrollment information.
Where is the NCT05806060 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT05806060 clinical trial?
NCT05806060 is sponsored by Fudan University. The trial plans to enroll 134 participants.
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