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

NCT ID: NCT05525767

Last Updated: 2025-12-11

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 75 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-31
• Study Completion Date: 2028-12-31

Brief Summary

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

Detailed Description

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

Conditions

Solid Tumor

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Assigned Interventions

Bevacizumab 10mg/Kg d1, 1/21d

Group Type: EXPERIMENTAL

Bevacizumab

Intervention Type: 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.

Interventions

Bevacizumab

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hebei Medical University Fourth Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Site Status: RECRUITING

Countries

China

Central Contacts

Cuizhi Geng

Role: CONTACT

gengcuizhi@hotmail.com

13503216325

Facility Contacts

Cuizhi Geng, M.D.

Role: primary

gengcuizhi@hotmail.com

0311-6669 6310

Other Identifiers

2021198-1

Identifier Type: -

Identifier Source: org_study_id