Solid TumorPhase 4NCT05525767
Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for HER2-negative Breast Cancer
A Phase 4 study testing Bevacizumab in people with Solid Tumor, run by Hebei Medical University Fourth Hospital at 1 site in China.
Trial summary
This is an prospective, multicenter, single-arm clinical study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Bevacizumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 31 Mar 2022to 31 Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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%;
- 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);
Show all 16Show fewer
- 5. The main organs function well and meet the following standards:
- Hemoglobin (HGB)≥90g/L;
- Neutrophil absolute value (NEUT)≥1.5×109/L;
- Platelet count (PLT)≥ 100×109/L;
- leukocyte ≥3.0×109/L;
- Total bilirubin <1.5 ULN (upper limit of normal)
- Creatinine < 1.5×ULN
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Cuizhi Geng, M.D., 0311-6669 6310, gengcuizhi@hotmail.com
About this study
Official title: Prospective, Multicenter, Single-arm Clinical Study of Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for Early or Locally Advanced HER2-negative Breast Cancer
This is an prospective, multicenter, single-arm clinical study.
Read the 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
- Being tested
- Bevacizumab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BevacizumabDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Assigned Interventions | Experimental | Bevacizumab 10mg/Kg d1, 1/21d Receives: Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCR
pathologic complete response
Measured: 24 months
Secondary outcomes (3)
ORR
objective response rate
Measured: 24 months
AE Advese Event Advese Event breast conservation rates
Advese Event
Measured: 24 months
BCR breast conservation rates
breast conservation rates
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2022
- Study start31 Mar 2022
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Hebei Medical University Fourth HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hebei Medical University Fourth Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525767
- Sponsor's protocol ID
- 2021198-1
- Status last verified
- Aug 2025
- First submitted
- 28 Aug 2022
- Last updated
- 11 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multicenter, Single-arm Clinical Study of Chemotherapy Combined With Bevacizumab Neoadjuvant Therapy for Early or Locally Advanced HER2-negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05525767
- Acronym / sponsor ID
- 2021198-1
- Conditions
- Solid Tumor
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Hebei Medical University Fourth HospitalUniversity, hospital or other
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 2 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Assigned Interventions | Experimental | Drug: BevacizumabBevacizumab 10mg/Kg d1, 1/21d |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- 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%;
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BevacizumabAll 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. | Drug | Assigned Interventions |
Primary outcome
PCR
Time frame: 24 months
pathologic complete response
3 secondary outcomes
ORR
Time frame: 24 months
AE Advese Event Advese Event breast conservation rates
Time frame: 24 months
BCR breast conservation rates
Time frame: 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Solid Tumor
RecruitingPhase 1/2
Study of INBRX-106 and INBRX-106 in Combination With Pembrolizumab (Keytruda®) in Subjects With Locally Advanced or Metastatic Solid Tumors (Hexavalent OX40 Agonist)
Solid Tumor, Non-Small Cell Lung Cancer
Active, not recruitingPhase 1
A Study to Assess Safety, Tolerability, and Pharmacokinetics of ABSK043 in Patients With Advanced Solid Tumor
Neoplasms
Active, not recruitingPhase 3
A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial
Solid Tumors
RecruitingPhase 1
IL-12 Genetically Engineered Myeloid Cells in Participants With Relapsed, Refractory Solid Tumors
Relapsed Solid Tumor Malignancies, Refractory Solid Tumor Malignancies
RecruitingObservational study
Immune Checkpoint Inhibitor Toxicity Risk Prediction in Solid Tumors
Malignant Solid Neoplasm
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bevacizumab in people with Solid Tumor, run by Hebei Medical University Fourth Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 16 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cuizhi Geng (13503216325, gengcuizhi@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PCR (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2025.