Targeted treatment for a specific subtype of triple-negative breast cancer
Precise Treatment for BLIS Subtype of Triple-negative Breast Cancer in the First-line Treatment of Locally Advanced or Metastatic Breast Cancer
This study is testing a new treatment combining VEGFR BP102 with nab-paclitaxel to see if it works better than standard options for people with a specific type of triple-negative breast cancer who haven't had chemotherapy before.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 134 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Fudan University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT05806060 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of VEGFR BP102 combined with nab-paclitaxel or a physician's choice of treatment in patients with the basal-like immune suppressed (BLIS) subtype of triple-negative breast cancer (TNBC). It focuses on individuals with locally advanced or metastatic TNBC who have not previously received chemotherapy or targeted therapy. The study aims to compare the outcomes of the new treatment regimen against standard treatment options in this specific patient population.
Who should consider this trial
Good fit: Ideal candidates are women with unresectable locally advanced or metastatic triple-negative breast cancer of the BLIS subtype who have not undergone prior chemotherapy for metastatic disease.
Not a fit: Patients with other subtypes of triple-negative breast cancer or those who have previously received chemotherapy for metastatic disease may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective first-line option for patients with the BLIS subtype of TNBC.
How similar studies have performed: While there have been studies targeting specific subtypes of breast cancer, this particular approach focusing on the BLIS subtype is relatively novel.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Shanghai, Shanghai Municipality
- Breast cancer institute of Fudan University Cancer Hospital — Shanghai, Shanghai Municipality, China (Recruiting)
Study contacts
- Study coordinator: Zhimin Shao
- Email: zhimingshao@yahoo.com
- Phone: 86-021-64175590
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.