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

NCT05525767 | Recruiting Phase 4

• 1 other identifier: 2021198-1
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solid Tumor

Outcome Measures

Primary Outcomes (1)

• PCR

  pathologic complete response

  24 months

Secondary Outcomes (3)

• ORR

  24 months

• AE Advese Event Advese Event breast conservation rates

  24 months

• BCR breast conservation rates

  24 months

Study Arms (1)

Assigned Interventions

EXPERIMENTAL

Bevacizumab 10mg/Kg d1, 1/21d

Drug: Bevacizumab

Interventions

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.

Assigned Interventions

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥18 years old;
• Signed the informed consent and volunteered to join the study with good compliance;
• , 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%);

You may not qualify if:

• 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;

Sponsors & Collaborators

• Hebei Medical University Fourth Hospital: lead

Study Sites (1)

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050011, China

RECRUITING

MeSH Terms

Interventions

Bevacizumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Cuizhi Geng

CONTACT

13503216325; gengcuizhi@hotmail.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 28, 2022
• First Posted: September 2, 2022
• Study Start: March 31, 2022
• Primary Completion (Estimated): October 31, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: December 11, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)