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

Solid Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05525767
• Other study ID #: 2021198-1
• Status: Recruiting
• Phase: Phase 4
• Start date: March 31, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: February 2022
• Source: Hebei Medical University Fourth Hospital
• Contact: Cuizhi Geng
• Phone: 13503216325
• Email: gengcuizhi[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2025
• Est. primary completion date: October 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Solid Tumor

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
China	The Fourth Hospital of Hebei Medical University	Shijiazhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
Hebei Medical University Fourth Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PCR	pathologic complete response	24 months
Secondary	ORR	objective response rate	24 months
Secondary	AE Advese Event Advese Event breast conservation rates	Advese Event	24 months
Secondary	BCR breast conservation rates	breast conservation rates	24 months