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Recruiting

NCT Number: NCT05525767

Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for HER2-negative Breast Cancer

This is an prospective, multicenter, single-arm clinical study.

Recruiting

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

Location status: Recruiting

Location contact

Cuizhi Geng, M.D.

CONTACT

[email protected]

0311-6669 6310

About this study

Prospective, multicenter, single-arm clinical study of chemotherapy combined with bevacizumab neoadjuvant therapy for early or locally advanced HER2-negative breast cancer

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years old;
  • 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%;
  • 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);
  • 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;

  • Cardiac ultrasound: left ventricular ejection fraction (LVEF≥55%);
  • The investigators determined that the patients were suitable for treatment with bevacizumab.

Exclusion criteria

  • Stage IV (metastatic) breast cancer;
  • Received treatment for the disease, including chemotherapy, endocrine therapy, radiotherapy, immunotherapy, etc.;
  • Patients who are participating in other intervention studies;
  • Women with confirmed pregnancy or lactation;
  • 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.

Treatment and study plan

Bevacizumab

Drug

All subjects enrolled will receive bevacizumab .Subjects continued to take medication until disease progression, unacceptable toxicity, withdrawal of informed consent, or discontinuation of medication at the discretion of the investigator.

Primary outcomes

  1. PCR

    Time frame: 24 months

    pathologic complete response

Secondary outcomes

  1. ORR

    Time frame: 24 months

    objective response rate

  2. AE Advese Event Advese Event breast conservation rates

    Time frame: 24 months

    Advese Event

  3. BCR breast conservation rates

    Time frame: 24 months

    breast conservation rates

Study contacts

Contact information is provided by the study sponsor or research team.

Cuizhi Geng

CONTACT

[email protected]

13503216325

Sponsors and collaborators

Lead sponsor

Hebei Medical University Fourth Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
Sep 2, 2022
Registry last updated
Dec 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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