Chemotherapy with Bevacizumab for HER2-negative Breast Cancer

Prospective, Multicenter, Single-arm Clinical Study of Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for Early or Locally Advanced HER2-negative Breast Cancer

This study is testing if adding a drug called bevacizumab to chemotherapy can help people with early or locally advanced HER2-negative breast cancer do better before surgery.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 75 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Hebei Medical University Fourth Hospital (Academic / other)
• Drugs / interventions: bevacizumab, chemotherapy, immunotherapy
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT05525767 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of combining chemotherapy with bevacizumab as neoadjuvant therapy for patients with early or locally advanced HER2-negative breast cancer. It is a prospective, multicenter, single-arm study that aims to evaluate the treatment's safety and efficacy. Participants will receive bevacizumab alongside standard chemotherapy regimens, with the goal of improving outcomes before surgical intervention. The study focuses on patients with specific histopathological criteria for HER2-negative invasive breast cancer.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with histopathologically confirmed HER2-negative invasive breast cancer at stages II to IIIC.

Not a fit: Patients with HER2-positive breast cancer or those with metastatic disease may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve the response rates and outcomes for patients with HER2-negative breast cancer.

How similar studies have performed: Other studies have shown promising results with similar combinations of chemotherapy and targeted therapies in breast cancer treatment.

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.

Where this trial is running

Shijiazhuang, Hebei

• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)

Study contacts

• Study coordinator: Cuizhi Geng

Conditions Solid Tumor