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

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

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
ChiCTR
Registry ID
ChiCTR2200058196
Enrollment
Unknown
Registered
2022-04-01
Start date
2022-03-31
Completion date
Unknown
Last updated
2023-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

breast cancer

Interventions

observation group:Nil

Sponsors

The fourth hospital of Hebei Medical University
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 85 Years

Inclusion criteria

Inclusion criteria: To be enrolled in this study, patients must meet the following inclusion criteria: 1. Be at least 18 years old; 2. Signed informed consent and voluntarily joined the study with good compliance; 3. Histopathological diagnosis of HER2-negative invasive breast cancer (including triple negative breast cancer; Or ER/PR positive and HER2 negative); -- HER2 negative was defined as 0/1+ on standard immunohistochemical (IHC) test; In ISH, 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 positive staining tumor cells in all tumor cells =1%( 4. The researchers judged that TNM stage II-IIIC (T2-T4) was consistent with the American Joint Committee on Cancer (AJCC) version 8. Plus any N, or any T plus n1-3, M0); 5. The patient agrees to receive breast cancer resection when the surgical criteria are met after neoadjuvant therapy; 6. The main organs function well and meet the following standards: A) Hemoglobin (HGB)=90g/L; B) Absolute value of neutrophils (NEUT)=1.5×109/L; C) Platelet count (PLT)= 100×109/L; D) White blood cell =3.0×109/L; E) Total bilirubin < 1.5uln (normal line) F) Creatinine < 1.5×ULN G) AST/ALT < 1.5×ULN; 7. Cardiac ultrasound: left ventricular ejection fraction (LVEF=55%); 8. The inestigators determined that the patient was suitable for bevacizumab - containing therapy.

Exclusion criteria

Exclusion criteria: 1. Stage IV (metastatic) breast cancer; 2. Have received treatment for the disease, including chemotherapy, endocrine therapy, radiation therapy, immunotherapy, etc.; 3. Patients who are participating in other intervention studies; 4. Confirmed pregnancy and lactation; 5. Subjects who, according to the investigator's judgment, have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or who are considered unsuitable for inclusion for other reasons.

Design outcomes

Primary

MeasureTime frame
Pathologic Complete Response;

Secondary

MeasureTime frame
Advese Event;Objective Response Rate;Breast Conservation Rates;

Countries

China

Contacts

Public ContactGENG CUIZHI
maggie92320@hotmail.com13503216325

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026