A Phase 3 interventional study of HS022 and Trastuzumab in HER2-positive Breast Cancer, sponsored by Zhejiang Hisun Pharmaceutical Co. Ltd.. Completed at 1 site in China. Open to female participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-10-30.
Sponsored by Zhejiang Hisun Pharmaceutical Co. Ltd. · Phase 3, Interventional, and Treatment
Among 1,927 studies in Breast Neoplasms with a site in China — 865 open to participants now, 1,063 under way, 210 of them phase 3. Breast Neoplasms · China.
Among the 1,927 studies in Breast Neoplasms with a site in China, this one is the 188th largest by enrollment of the 1,518 interventional ones, is one of 72 that started in 2018, is one of 331 in phase 3, and was the 1,070th registered.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 570 is above the median of 72 across 10,896 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →865 of the 1,927 studies in Breast Neoplasms with a site in China are open now, in 12 countries. Each count lists the studies.
Of the 2,400 Breast Neoplasms studies recruiting now, 1,572 (66%) set no upper age limit and 591 (25%) stop at 75 or younger; 103 take children under 18; 214 take healthy volunteers.
This study: 18 Years to 75 Years · female · no healthy volunteers.
The full table on the hub →1,927 studies; the count open now beside each. This study's row is marked.
First in 1997; this study’s year is marked. 72 started in 2018.
Median enrollment 120 across the 1,518 interventional studies, 240 across the 407 observational. Of the 444 that completed or were terminated, 77 (17%) have results posted.
488 of 1,927 have an industry lead sponsor. The 10 most frequent:
Zhejiang Hisun Pharmaceutical Co. Ltd. is the lead sponsor of 18 studies on the registry; 2 are open to participants now.
Zhejiang Hisun Pharmaceutical Co. Ltd. has 1 study filed under Breast Neoplasms — fewer than ten, so there is no comparison to draw.
256 of the studies in Breast Neoplasms with a site in China that are under way reach primary completion within a year, 43 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05646862Phase 3Hoffmann-La RocheA Study Evaluating the Efficacy and Safety of Inavolisib Plus Fulvestrant Compared With Alpelisib Plus Fulvestrant in Participants With HR-Positive, HER2-Negative, PIK3CA Mutated, Locally Advanced or Metastatic Breast Cancer Post CDK4/6i and Endocrine Combination Therapy | 2026-11-13 |
| NCT06954961Phase 3InventisBio Co., LtdA Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer | 2026-11-30 |
| NCT06968585Phase 3Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd.A Study of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy | 2026-11-30 |
| NCT05780567Phase 3Chia Tai Tianqing Pharmaceutical Group Co., Ltd.Clinical Study on Adjuvant Therapy of TQB3616 Combined With Endocrine Therapy Compared With Placebo Combined With Endocrine Therapy in Patients With Breast Cancer | 2026-12 |
| NCT04639986Phase 3Gilead SciencesAsian Study of Sacituzumab Govitecan (IMMU-132) in HR+/HER2- Metastatic Breast Cancer (MBC) | 2026-12 |
Among the 1,927 studies in Breast Neoplasms with a site in China, from their registry updates:
This is a multi-center, randomized, double-blind, parallel-group study to evaluate the efficacy and safety and Immunogenicity of Vinorelbine Bitartrate Injection in Combination With HS022 and Trastuzumab®.There were 2 parts. Part 1 needs 8 treatment cycles ( at least 24 weeks); Part2 needs 9 treatment cycles (at least 27 weeks).
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Female ≥18 and ≤75 years of age on day of signing the form (ICF).
5.No prior systemic anticancer agent such as chemotherapy, biological or targeted agent for disease. For patients with recurrent disease, prior neo-/ therapy containing trastuzumab must have been stopped at least 12 months before the diagnosis of recurrent (local or metastatic) disease.
6.Those with at least one measurable target lesion ( 1.1 standard): at least one diameter line of the target lesion can be accurately measured, and the lesions, skin lesions, brain lesions, and bone metastases of any type after radiotherapy or other local regional treatment can only be evaluated as non-target lesions; 7. \< 2； 8. (LVEF) ≥ 50% within 4 weeks before randomization; 9.Adequate hematology, liver function and kidney function, as shown in the following laboratory test values；
.a) Absolute value of neutrophil ≥ 1.5 × 109/L； b) ≥ 100 × 109/L, and ≥ 90g/L; c) Total serum ≤ 1.5 times the value (except for Gilbert syndrome); d) and AST ≤ 2.5 times the upper limit of normal value (subjects with liver metastasis ≤ 5 times the upper limit of normal value); e) Blood creatinine ≤ 1.5 times the upper limit of normal value. 10.The expected survival period ≥ 3 months. 11. Patients have voluntarily agreed to participate and given written informed consent.
Exclusion Criteria:
.Prior surgery within 4 weeks preceeding enrollment or expected to be performed during the trial, prior chemotherapy wihtin 4 weeks preceeding enrollment, prior radiotherapy or endocrinotherapy within 4 weeks before enrollment.
2.Prior treatment with vinorelbine 3.Current peripheral neuropathy above 2 grades 4.Known or other CNS metastasis that is either symptomatic or untreated. Central nervous system that have been treated by complete resection and/or radiotherapy demonstrating stability or improvement are not an exclusion criterion provided they are stable as shown by computed tomography (CT) or magnetic resonance imaging (MRI) scan for at least 4 weeks before Screening without evidence of cerebral edema and no requirements for or anticonvulsants.
5.Participation in another clinical study within 4 weeks before enrollment (3 months for studies involving monoclonal therapy), excluding those who failed in screening;
Myocardial infarction occurred within 6 months before signing the ;
The researcher believes that it is not suitable for enrollment or may not be able to complete the test for other reasons.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HER2
HER2 is a protein, made from the ERBB2 gene, that drives the growth of some cancers. A study may look for a level of the protein, extra copies of the gene, or a particular change in it.
In breast cancer, protein tests are read as HER2-positive, HER2-low or HER2-negative; other cancers use their own rules. Check which test result the study requires.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Metastases
Cancer that has spread from where it began to other parts of the body. “Metastatic” cancer is cancer that has spread this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Adjuvant and neoadjuvant
Neoadjuvant treatment is given before the main treatment (usually surgery), often to shrink a tumour. Adjuvant treatment is given after it, to lower the chance of the cancer coming back.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
RECIST
The standard rules for measuring tumours on CT or MRI scans, to tell whether a cancer is shrinking, stable or growing during treatment.
“Measurable disease per RECIST 1.1” usually means at least one tumour 10 mm or more at its longest on a CT scan, or a lymph node 15 mm or more across its short axis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Brain metastases
Cancer deposits in the brain from a cancer that started elsewhere in the body (CNS metastases include the spinal cord).
Studies differ: some leave out any brain metastases, some accept ones treated and stable for some weeks. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Drug: HS022 · Drug: Vinorelbine Bitartrate
Drug: Trastuzumab · Drug: Vinorelbine Bitartrate
8 treatment cycles, 3 weeks/cycle, 24 weeks. The first dose is 8 mg/kg , and then 6 mg/kg .3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first. The second stage 9 treatment cycles, 3 weeks/cycle, 27 weeks. 6mg/kg
8 treatment cycles, 3 weeks/cycle, 24 weeks. The first dose is 8 mg/kg , and then 6 mg/kg .3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first. The second stage 9 treatment cycles, 3 weeks/cycle, 27 weeks. 6mg/kg
Vinorelbine: 25mg/m2 (intravenous infusion, day 1 and 8 of each cycle). 3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first. Second section:9 treatment cycles, 3 weeks/cycle, 27 weeks. Vinorelbine: 25mg/m2 (intravenous infusion, day 1 and 8 of each cycle). The investigator may decide whether to continue treatment with vinorelbine at his discretion. 3 weeks/cycle, continue until the disease progresses, intolerable toxic reaction occurs, or the subject voluntarily withdraws from the clinical trial, whichever occurs first.
ORR
The best overall response rate (ORR24: performed at the 25th week): According to the Solid Tumor Efficacy Evaluation Standard (RECIST) 1.1, the proportion of CR and PR subjects from the first evaluation (baseline) to the 25th week of treatment (after the completion of 8 treatment cycles) (note: including unconfirmed response).
Time frame: WEEK 25
DCR
Disease control rate (DCR: in the 25th week): DCR=CR+PR+SD。
Time frame: WEEK 25
PFS
Progression-free survival (PFS: the 52nd week): according to RECIST1.1, the time from the date of randomization to the date of disease progression or all-cause death (whichever occurs first). If the subjects did not have the above events, the PFS would be closed to the date of the last full tumor evaluation.
Time frame: WEEK 52
OS
Total survival rate (OS rate: performed at the 52nd week): defined as the percentage of subjects who survived at 51 weeks after randomization.
Time frame: WEEK 52
Vital signs
temprature
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
Vital signs
pulse rate
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
Vital signs
respiration（in times/minute）
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
Vital signs
blood pressure (systolic/diastolic，in mmHg)
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
physical examination,
Perform a physical examination at each visit
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
ADAs
The incidence of anti-drug antibodies (ADAs) before treatment, after 2 cycles of treatment, after 4 cycles, after 6 cycles, after 8 cycles, after 12 cycles, on the 22nd day after the last administration of 17 cycles/on the 22nd day after the last administration (test/non test drug) of early withdrawal
Time frame: on the 22nd day after the last administration
Ctrough
Collect serum samples for PK testing according to the protocol/laboratory manual, and transport them to the biological sample analysis laboratory for unified testing and analysis
Time frame: In two hours before the administration of the trial drug on the first day of the 1st, 3rd, 5th and 7th cycles, the 22nd day of the 8th cycle)/the 22nd day after the last administration. Each cycle was 21 days.
ECOG physical condition
ECOG physical condition
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
left ventricular ejection fraction (LVEF),
left ventricular ejection fraction (LVEF),
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
adverse events (AE)
adverse events (AE)
Time frame: first day and the 8th day at each visit prior to administration（1st cycle , the 2nd cycle, the 3rd cycle, the 4th cycle the 5th cycle, the 6th cycle,the 7th cycle,the 8th cycle,or the 22nd day after the last administration of the early withdrawal.
Plan to share: Undecided
No publications or documents are linked to this record.
Ran from May 2018 to primary completion in Jan 2022, 44 months.
Of 272 industry-sponsored phase 3 interventional studies under Breast Neoplasms, half reached primary completion within 40 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 63. This study's 44 months is close to that.
Counting every sponsor, half of 600 studies reached it within 59 months; a quarter within 36 and three quarters within 96.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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Zhejiang Hisun Pharmaceutical Co. Ltd.