NCT05525767 Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for HER2-negative Breast Cancer
| NCT ID | NCT05525767 |
| Status | Recruiting |
| Phase | Phase 4 |
| Sponsor | Hebei Medical University Fourth Hospital |
| Condition | Solid Tumor |
| Study Type | INTERVENTIONAL |
| Enrollment | 75 participants |
| Start Date | 2022-03-31 |
| Primary Completion | 2026-10-31 |
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 4 studies follow an already-approved treatment in real-world conditions to monitor long-term safety and effectiveness.
This trial targets 75 participants in total. It began in 2022-03-31 with a primary completion date of 2026-10-31.
⚠ 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
This is an prospective, multicenter, single-arm clinical study.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years old; 2. Signed the informed consent and volunteered to join the study with good compliance; 3, histopathologically confirmed HER2-negative invasive breast cancer (including triple-negative breast cancer; Or Luminal breast cancer, that is, ER/PR positive and HER2 negative) : * HER2 negative was defined as 0/1+ on standard IHC test; HER2/CEP17 ratio was less than 2.0 or HER2 gene copy number was less than 4. * ER positive and/or PR positive were defined as the proportion of positively stained tumor cells in all tumor cells ≥1%; 4\. According to the American Joint Committee on Cancer (AJCC) 8th edition TNM stage II-IIIC (T2-T4 plus any N, or any T plus N1-3, M0); 5\. The main organs function well and meet the following standards: A) Hemoglobin (HGB)≥90g/L; B) Neutrophil absolute value (NEUT)≥1.5×109/L; C) Platelet count (PLT)≥ 100×109/L; D) leukocyte ≥3.0×109/L; E) Total bilirubin \<1.5 ULN (upper limit of normal) F) Creatinine \< 1.5×ULN G) AST/ALT \< 1.5×ULN; 6\. Cardiac ultrasound: left ventricular ejection fraction (LVEF≥55%); 7\. The investigators determined that the patients were suitable for treatment with bevacizumab. Exclusion Criteria: 1. Stage IV (metastatic) breast cancer; 2. Received treatment for the disease, including chemotherapy, endocrine therapy, radiotherapy, immunotherapy, etc.; 3. Patients who are participating in other intervention studies; 4. Women with confirmed pregnancy or lactation; 5. According to the judgment of the investigator, the subjects have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or the subjects think that there are other reasons that are not suitable for inclusion.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05525767 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Solid Tumor. 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 NCT05525767 trial and what does that mean for participants?
Phase 4 studies are conducted after a treatment has been approved. They monitor long-term safety and real-world effectiveness in a broader patient population.
Is NCT05525767 currently recruiting?
Yes, NCT05525767 is actively recruiting participants. Contact the research team at gengcuizhi@hotmail.com for enrollment information.
Where is the NCT05525767 trial being conducted?
This trial is being conducted at Shijiazhuang, China.
Who is sponsoring the NCT05525767 clinical trial?
NCT05525767 is sponsored by Hebei Medical University Fourth Hospital. The trial plans to enroll 75 participants.