Clinical trial Recruiting at 1 site Phase 4 Interventional Ages 18 and up

Chemotherapy with Bevacizumab for HER2-negative Breast Cancer

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

Run by Hebei Medical University Fourth Hospital · NCT05525767 · Data updated 2026-11-12

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.

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Quick facts

PhasePhase 4
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment75 (estimated)
SponsorHebei Medical University Fourth Hospital
Academic / other
Drugs / interventionsbevacizumab, chemotherapy, immunotherapy
Locations1 site (Shijiazhuang, Hebei)
StatusRecruiting
StartedMarch 31, 2022
Main results expectedOctober 31, 2026
Study endsDecember 31, 2028
Registry record updatedDecember 11, 2025
Trial IDNCT05525767 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

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

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

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

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.