Triple-negative Breast CancerPhase 2NCT05192798
Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic TNBC
A Phase 2 study testing Albumin-Bound Paclitaxel, Apatinib Mesylate and Bevacizumab in people with Triple-negative Breast Cancer, run by The First Affiliated Hospital of Bengbu Medical University at 1 site in China.
Trial summary
This is a prospective, randomized, open-label clinical study. 128 patients with relapsed or metastatic triple-negative breast cancer (TNBC) who had not been systematically treated are going to be enrolled and randomly assigned to 3 groups. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Triple-negative Breast Cancer
- What is being tested?
- Albumin-Bound Paclitaxel, Apatinib Mesylate and Bevacizumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 128 participants
- Where
- 1 siteChina
- Study dates
- 14 Jan 2022to 1 Dec 2027
- Phase
- Phase 2
- 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 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years and ≤80 years;
- Patients with recurrent or metastatic triple negative breast cancer confirmed by histopathology and imaging;
- Presence of at least one measurable lesion according to RECIST 1.1;
- Expected survival ≥3 months;
- Eastern Cooperative Oncology Group performance status (ECOG PS) : 0-2;
- Patients who have not previously received antitumor systemic therapy for the stage of relapse or metastasis;
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- For subjects who have previously undergone adjuvant/neoadjuvant therapy, the time from the end of the last chemotherapy (including taxanes) to randomization should be ≥12 months; The time from the end of radical radiotherapy to randomization should be ≥6 months.
- Major organs show good function, and the relevant examination indexes within 7 days prior to randomization meet the following requirements:
- Absolute neutrophil count ≥ 1.5 x 10^9 / L;
- Platelet count ≥ 100 x 10^9 / L;
- Hemoglobin ≥ 90 g/L;
- Alanine aminotransferase (ALT) and aspartate transaminase (AST) ≤2.5 × upper limit of normal (ULN); ALT and AST≤5 × ULN if liver metastasis is present;
- Creatinine clearance rate(Ccr) ≥60 mL/min according to the Cockcroft-Gault formula;
- Prothrombin time (PT) and activated partial thromboplastin time (APTT) ≤1.5 × ULN, and international normalized ratio (INR)≤1.5 × ULN.
- Subjects voluntarily agree to participate in the study and sign informed consent, with good compliance and being accessible for treatment and follow-up.
Who cannot join
- Patients who are pregnant or breast-feeding;
- Patients with multiple factors affecting oral medication (such as swallow inability, chronic diarrhea and intestinal obstruction);
- Known hypersensitivity reaction to any of the components of the treatment;
- Peripheral neuropathy ≥ grade 2, whatever the cause;
- Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate <50 at rest) or heart rate-corrected QT interval via Fridericia (QTcF) ≥470 msec.
- Patients with urinary protein ≥++ indicated by routine urine examination, and the 24-hour urine protein level was confirmed to be > 1.0g;
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- Patients with imaging showing that the tumor has invaded important blood vessels or the investigator judges that the tumor is highly likely to invade important blood vessels and cause fatal massive bleeding during the follow-up study;
- Patients who have experienced arteriovenous or venous thrombosis events within 6 months prior to randomization, such as cerebrovascular accident (including temporary ischemic attack), deep vein thrombosis and pulmonary embolism;
- Any bleeding or bleeding event ≥grade 3 within 4 weeks prior to the first dose of therapy; Or the presence of unhealed wounds, fractures, gastrointestinal diseases such as gastric and duodenal active ulcers, ulcerative colitis, or active bleeding of unresected tumors, or other conditions that may cause gastrointestinal bleeding or perforation as determined by the investigator;
- Uncontrolled effusion management (pleural effusion, pericardial effusion, or ascites) which requires frequent drainage procedures;
- Previous malignancy within 5 years, with exception of a history of a previous basal cell carcinoma of the skin or pre-invasive carcinoma of the cervix;
- Participants in clinical trials of other antitumor drugs within 4 weeks prior to randomization;
- Other circumstances in which participation in the study would be inappropriate as determined by the investigator.
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
Department of Medical Oncology, First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233004
Jing Jing, M.D., +86-552-3086178, 15805692769@163.com
Yan Yang, M.D., Ph.D.
About this study
Official title: A Prospective, Randomized, Open Label Clinical Study Evaluating Efficacy and Safety of Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic Triple Negative Breast Cancer
This is a prospective, randomized, open-label clinical study. 128 patients with relapsed or metastatic triple-negative breast cancer (TNBC) who had not been systematically treated are going to be enrolled and randomly assigned to 3 groups. Group A: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks). Group B: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks)+ apatinib mesylate tablet (500 mg, orally, once daily, every 3 weeks). Group C: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks) + bevacizumab (7.5mg/kg, intravenous infusion, once every 3 weeks). The dosages of therapeutic drugs are allowed to be adjusted appropriately according to the toxic reaction of the patients. Patients in three groups continued to take medication until disease progression/death/toxicity was intolerable/the patient or investigator decided to discontinue the medication.
The primary endpoint is progression-free survival (PFS). Secondary endpoints are objective response rate (ORR), clinical benefit rate (CBR, complete response (CR)+ partial response (PR) + stable disease (SD, > 6 months)), overall survival (OS), adverse events (AE), and potential predictive biomarker parameters related to treatment response (VEGF-A expression level) in peripheral blood.
Read the detailed description
Triple-negative breast cancer (TNBC) is a special type of breast cancer (BC), which cannot benefit from endocrine therapy and anti-human epidermal growth factor receptor-2 (HER-2) therapy due to lack of corresponding targets. Thus, it confers a hot spot and difficulty in clinical and basic research of BC. At present, the clinical treatment of TNBC is mainly relayed on chemotherapy based on anthracycline and taxane drugs with an unsatisfactory therapeutic effects and outcomes of the patients. Although data have suggested that antiangiogenic agents may have some benefit to TNBC patients, there seems to be a lack of clinical trials evaluating efficacy and safety of albumin paclitaxel combined with antiangiogenic agents in first-line treatment of relapsed or metastatic TNBC.
This is a prospective, randomized, open-label clinical study. 128 patients with relapsed or metastatic triple-negative breast cancer (TNBC) who had not been systematically treated are going to be enrolled and randomly assigned to 3 groups. Group A: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks). Group B: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks)+ apatinib mesylate tablet (500 mg, orally, once daily, every 3 weeks). Group C: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks) + bevacizumab (7.5mg/kg, intravenous infusion, once every 3 weeks). The dosages of therapeutic drugs are allowed to be reduced, among which the lowest allowable dosage of apatinib and bevacizumab can be reduced to 250mg and 5mg/kg, respectively. The dosage of albumin-bound paclitaxel can be adjusted appropriately according to the toxic reaction of the patients. The lowest allowable dosage of albumin-bound paclitaxel can be reduced to 180mg/m2, specifically. Patients in three groups continued to take medication until disease progression/death/toxicity was intolerable/the patient or investigator decided to discontinue the medication.
The primary endpoint is progression-free survival (PFS). Secondary endpoints are objective response rate (ORR), CBR (CR+PR+SD (> 6 months)), overall survival (OS), adverse events (AE), and potential predictive biomarker parameters related to treatment response (VEGF-A expression level) in peripheral blood.
For statistical description, Kaplan-Meier method is used to plot the progression-free survival curve and estimate the median progression-free survival and its 95% confidence interval. The secondary analysis is to plot the overall survival curve using Kaplan-Meier method and estimate its 95% confidence interval. Log-rank test is used to analyze the overall survival of the main stratified factors. Objective response rate, disease control rate and 95% confidence interval are also calculated.
The safety analyses will be mainly descriptive statistical analyses, listing the incidence, severity, association, risk, and outcome of adverse events that will occur in this study.
- Conditions
- Triple-negative Breast Cancer
- Being tested
- Albumin-Bound Paclitaxel, Apatinib Mesylate, Bevacizumab
- Keywords
- Triple-negative breast cancer, Albumin-bound paclitaxel, Bevacizumab, Apatinib, First-line therapy
- Medical subject headings
- Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Albumin-Bound PaclitaxelDrug
Albumin-bound paclitaxel is one of the standard first-line regimens for relapsed or metastatic triple-negative breast cancer.
Apatinib MesylateDrug
Apatinib mesylate is an orally administered small-molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor (TKI).
BevacizumabDrug
Bevacizumab is a humanized anti-VEGF monoclonal antibody once approved by FDA for treatment of metastatic breast cancer in combination with chemotherapy.
| Study group | Role | What they receive |
|---|---|---|
| Group of albumin-bound paclitaxel | Active comparator | Albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks). Receives: Drug: Albumin-Bound Paclitaxel |
| Group of albumin-bound paclitaxel combined with apatinib | Experimental | Albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks)+ apatinib mesylate tablet (500 mg, orally, once daily, every 3 weeks). Receives: Drug: Albumin-Bound Paclitaxel; Drug: Apatinib Mesylate |
| Group of albumin-bound paclitaxel combined with bevacizumab | Experimental | Albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks) + bevacizumab (7.5mg/kg, intravenous infusion, once every 3 weeks). Receives: Drug: Albumin-Bound Paclitaxel; Drug: Bevacizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS)
PFS is defined as the time from randomization until objective tumor progression or death.
Measured: 2 Years.
Secondary outcomes (5)
Clinical Benefit Rate (CBR)
CBR is defined as the proportion of patients who have a complete, partial response or stable disease for more than 6 months to therapy.
Measured: 2 Years.
objective response rate (ORR)
ORR is defined as the proportion of patients who have a partial or complete response to therapy.
Measured: 2 Years.
Overall Survival (OS)
OS is defined as the time from randomization to the time of death from any cause.
Measured: 2 Years.
Adverse Event (AE)
An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment.
Measured: 2 Years.
Serum VEGF-A
Potential predictive biomarker parameter in peripheral blood related to tumor response.
Measured: 2 Years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start14 Jan 2022
- Primary completion10 Sep 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Triple-negative Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 128 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yan Yang, MD, Ph.D, The First Affiliated Hospital of Bengbu Medical University
- Investigators
- Yan Yang, M.D.,Ph.D, Principal investigator, The First Affiliated Hospital of Bengbu Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05192798
- Sponsor's protocol ID
- BYEC20211201
- Status last verified
- Sep 2026
- First submitted
- 11 Dec 2021
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- 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 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Open Label Clinical Study Evaluating Efficacy and Safety of Albumin-Bound Paclitaxel Combined With Antiangiogenic Agents in First-line Treatment of Relapsed or Metastatic Triple Negative Breast Cancer
- ClinicalTrials.gov ID
- NCT05192798
- Acronym / sponsor ID
- BYEC20211201
- Conditions
- Triple-negative Breast Cancer
- Keywords
- Triple-negative breast cancer, Albumin-bound paclitaxel, Bevacizumab, Apatinib, First-line therapy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 128 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Bengbu Medical UniversityUniversity, hospital or other
- Study start
- 14 Jan 2022 (actual)
- Primary completion
- 10 Sep 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 14 Jan 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 a prospective, randomized, open-label clinical study. 128 patients with relapsed or metastatic triple-negative breast cancer (TNBC) who had not been systematically treated are going to be enrolled and randomly assigned to 3 groups. Group A: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks). Group B: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks)+ apatinib mesylate tablet (500 mg, orally, once daily, every 3 weeks). Group C: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks) + bevacizumab (7.5mg/kg, intravenous infusion, once every 3 weeks). The dosages of therapeutic drugs are allowed to be adjusted appropriately according to the toxic reaction of the patients. Patients in three groups continued to take medication until disease progression/death/toxicity was intolerable/the patient or investigator decided to discontinue the medication.
The primary endpoint is progression-free survival (PFS). Secondary endpoints are objective response rate (ORR), clinical benefit rate (CBR, complete response (CR)+ partial response (PR) + stable disease (SD, > 6 months)), overall survival (OS), adverse events (AE), and potential predictive biomarker parameters related to treatment response (VEGF-A expression level) in peripheral blood.
Detailed description
Triple-negative breast cancer (TNBC) is a special type of breast cancer (BC), which cannot benefit from endocrine therapy and anti-human epidermal growth factor receptor-2 (HER-2) therapy due to lack of corresponding targets. Thus, it confers a hot spot and difficulty in clinical and basic research of BC. At present, the clinical treatment of TNBC is mainly relayed on chemotherapy based on anthracycline and taxane drugs with an unsatisfactory therapeutic effects and outcomes of the patients. Although data have suggested that antiangiogenic agents may have some benefit to TNBC patients, there seems to be a lack of clinical trials evaluating efficacy and safety of albumin paclitaxel combined with antiangiogenic agents in first-line treatment of relapsed or metastatic TNBC.
This is a prospective, randomized, open-label clinical study. 128 patients with relapsed or metastatic triple-negative breast cancer (TNBC) who had not been systematically treated are going to be enrolled and randomly assigned to 3 groups. Group A: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks). Group B: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks)+ apatinib mesylate tablet (500 mg, orally, once daily, every 3 weeks). Group C: albumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks) + bevacizumab (7.5mg/kg, intravenous infusion, once every 3 weeks). The dosages of therapeutic drugs are allowed to be reduced, among which the lowest allowable dosage of apatinib and bevacizumab can be reduced to 250mg and 5mg/kg, respectively. The dosage of albumin-bound paclitaxel can be adjusted appropriately according to the toxic reaction of the patients. The lowest allowable dosage of albumin-bound paclitaxel can be reduced to 180mg/m2, specifically. Patients in three groups continued to take medication until disease progression/death/toxicity was intolerable/the patient or investigator decided to discontinue the medication.
The primary endpoint is progression-free survival (PFS). Secondary endpoints are objective response rate (ORR), CBR (CR+PR+SD (> 6 months)), overall survival (OS), adverse events (AE), and potential predictive biomarker parameters related to treatment response (VEGF-A expression level) in peripheral blood.
For statistical description, Kaplan-Meier method is used to plot the progression-free survival curve and estimate the median progression-free survival and its 95% confidence interval. The secondary analysis is to plot the overall survival curve using Kaplan-Meier method and estimate its 95% confidence interval. Log-rank test is used to analyze the overall survival of the main stratified factors. Objective response rate, disease control rate and 95% confidence interval are also calculated.
The safety analyses will be mainly descriptive statistical analyses, listing the incidence, severity, association, risk, and outcome of adverse events that will occur in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group of albumin-bound paclitaxel | Active comparator | Drug: Albumin-Bound PaclitaxelAlbumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks). |
| Group of albumin-bound paclitaxel combined with apatinib | Experimental | Drug: Albumin-Bound Paclitaxel, Drug: Apatinib MesylateAlbumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks)+ apatinib mesylate tablet (500 mg, orally, once daily, every 3 weeks). |
| Group of albumin-bound paclitaxel combined with bevacizumab | Experimental | Drug: Albumin-Bound Paclitaxel, Drug: BevacizumabAlbumin-bound paclitaxel (260mg/m2, intravenous infusion, once every 3 weeks) + bevacizumab (7.5mg/kg, intravenous infusion, once every 3 weeks). |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Female patients aged ≥18 years and ≤80 years;
- Patients with recurrent or metastatic triple negative breast cancer confirmed by histopathology and imaging;
- Presence of at least one measurable lesion according to RECIST 1.1;
- Expected survival ≥3 months;
- Eastern Cooperative Oncology Group performance status (ECOG PS) : 0-2;
Key exclusion criteria (13 listed)
- Patients who are pregnant or breast-feeding;
- Patients with multiple factors affecting oral medication (such as swallow inability, chronic diarrhea and intestinal obstruction);
- Known hypersensitivity reaction to any of the components of the treatment;
- Peripheral neuropathy ≥ grade 2, whatever the cause;
- Serious other diseases as infections (hepatitis B, C and HIV), recent myocardial infarction, clinical signs of cardiac failure or clinically significant arrhythmias or on screening, any of the following cardiac parameters: bradycardia (heart rate <50 at rest) or heart rate-corrected QT interval via Fridericia (QTcF) ≥470 msec.
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 |
|---|---|---|
| Albumin-Bound PaclitaxelAlbumin-bound paclitaxel is one of the standard first-line regimens for relapsed or metastatic triple-negative breast cancer. | Drug | Group of albumin-bound paclitaxel, Group of albumin-bound paclitaxel combined with apatinib, Group of albumin-bound paclitaxel combined with bevacizumab |
| Apatinib MesylateApatinib mesylate is an orally administered small-molecule vascular endothelial growth factor receptor-2 (VEGFR-2) tyrosine kinase inhibitor (TKI). | Drug | Group of albumin-bound paclitaxel combined with apatinib |
| BevacizumabBevacizumab is a humanized anti-VEGF monoclonal antibody once approved by FDA for treatment of metastatic breast cancer in combination with chemotherapy. | Drug | Group of albumin-bound paclitaxel combined with bevacizumab |
Primary outcome
Progression-free Survival (PFS)
Time frame: 2 Years.
PFS is defined as the time from randomization until objective tumor progression or death.
5 secondary outcomes
Clinical Benefit Rate (CBR)
Time frame: 2 Years.
objective response rate (ORR)
Time frame: 2 Years.
Overall Survival (OS)
Time frame: 2 Years.
Adverse Event (AE)
Time frame: 2 Years.
Serum VEGF-A
Time frame: 2 Years.
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 4 Sep 2026.
- Individual participant dataSharing planned: No
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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.
Yan Yang, M.D.,Ph.D principal investigator
The First Affiliated Hospital of Bengbu Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Albumin-Bound Paclitaxel, Apatinib Mesylate and Bevacizumab in people with Triple-negative Breast Cancer, run by The First Affiliated Hospital of Bengbu Medical University 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 15 inclusion and 13 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 4 Sep 2026. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Jing Liu, M.D. (+86-0552-3086178, 15805692769@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression-free Survival (PFS) (time frame: 2 Years.). 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 4 Sep 2026.