Phase III Clinical Trial Comparing the Safety, Efficacy, and Immunogenicity of HS022 and Trastuzumab® in Combination With Vinorelbine Bitartrate Injection in the Treatment of HER2-positive Breast Cancer

Zhejiang Hisun Pharmaceutical Co. Ltd.1 site in 1 country570 target enrollmentMay 16, 2018

ConditionsHER2-positive Breast Cancer

InterventionsHS022 Vinorelbine Bitartrate Trastuzumab

DrugsHS022 Trastuzumab Vinorelbine Bitartrate

Overview

Phase: Phase 3
Intervention: HS022
Conditions: HER2-positive Breast Cancer
Sponsor: Zhejiang Hisun Pharmaceutical Co. Ltd.
Enrollment: 570
Locations: 1
Primary Endpoint: ORR
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

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).

Registry

clinicaltrials.gov

Start Date

May 16, 2018

End Date

January 28, 2022

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

Zhejiang Hisun Pharmaceutical Co. Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Female ≥18 and ≤75 years of age on day of signing the informed consent form (ICF).
•Histologically or cytologically confirmed adenocarcinoma of the breast.
•Recurrent disease not amenable to curative surgery or radiation therapy.
•HER2-positivity, based on IHC score 3+ or ISH positivity. For those IHC score 2+ patients, fluorescence in situ hybridization (FISH), chromogenic in situ hybridization (CISH) or silver enhanced in situ hybridization (SISH) should be tested to prove HER2 gene amplification.
•5.No prior systemic anticancer agent such as chemotherapy, biological or targeted agent for metastatic disease. For patients with recurrent disease, prior neo-/adjuvant 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 (RECIST 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.ECOG \< 2； 8.Left ventricular ejection fraction (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) Platelet ≥ 100 × 109/L, and hemoglobin ≥ 90g/L; c) Total serum bilirubin ≤ 1.5 times the upper limit of normal value (except for Gilbert syndrome); d) ALT 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.
•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 brain metastasis or other CNS metastasis that is either symptomatic or untreated. Central nervous system metastases 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 corticosteroids 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;
•Patients with any other malignant tumor in the past five years, excluding fully cured cervical carcinoma in situ, basal cell or squamous cell skin cancer;
•Have a clear history of neurological or mental disorders, including epilepsy or dementia;
•Those who are allergic to any ingredient or excipient of the test drug, including those who are allergic to benzyl alcohol;
•Those who have received whole blood or component blood transfusion within 2 weeks before randomization;
•Those who currently suffer from diseases affecting intravenous injection and venous blood collection;
•At present, there are serious and uncontrollable systemic diseases (such as dyspnea, bronchospasm, acute attack of asthma or other diseases requiring continuous oxygen inhalation treatment), which, according to the judgment of the researcher, will significantly affect the participation/completion of the test and efficacy evaluation of the subjects;
•Have any of the following heart diseases:

Arms & Interventions

HS022+ Vinorelbine Bitartrate

Intervention: HS022

HS022+ Vinorelbine Bitartrate

Intervention: Vinorelbine Bitartrate

Trastuzumab®+ Vinorelbine Bitartrate Injection

Intervention: Trastuzumab

Trastuzumab®+ Vinorelbine Bitartrate Injection

Intervention: Vinorelbine Bitartrate

Outcomes

Primary Outcomes

ORR

Time Frame: WEEK 25

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).

Secondary Outcomes

DCR(WEEK 25)
Vital signs(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.)
OS(WEEK 52)
Ctrough(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(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.)
PFS(WEEK 52)
physical examination,(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(on the 22nd day after the last administration)
left ventricular ejection fraction (LVEF),(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)(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.)