Trials Sponsors Conditions Drugs Pricing

Conditions

HER-2-positive Advanced Breast Cancer

Outcome Measures

Primary Outcomes (1)

Progression-free survival, PFS
To evaluate the efficacy of GB221 as defined by progression-free survival in patients with breast cancer.
through study completion, an average of 2 year

Secondary Outcomes (4)

Objective Response Rate, ORR
through study completion, an average of 2 year
Antidrug antibody, ADA
through study completion, an average of 2 year
Overall survival, OS
through study completion, an average of 2 year
PFS in the extended treatment phase
through study completion, an average of 2 year

Study Arms (2)

GB221+ Capecitabine tablets

EXPERIMENTAL

test drug+capecitabine

Drug: GB221

Placebo control + capecitabine tablets

PLACEBO COMPARATOR

placebo+capecitabine

Drug: Placebo control

Interventions

GB221Drug

GB221:Lyophilized powder for injection; strength 110mg/bottle; the first administration of 8 mg/kg, intravenous drip for over 90 minutes; subsequently, the administration shall be given once every 3 weeks (one cycle), the dose is 6 mg/kg, intravenous drip for 30\~90 minutes; The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study. Capecitabine:Tablets; 500mg/tablet, 12 tablets/box; Total daily dose 2000 mg/m2, orally twice daily, one dose each in the morning and evening, administration for 2 weeks followed by a 1-week rest period, as a 3-week cycle. The administration shall be continued until disease progression or presence of intolerable toxic reactions or subject's active withdrawal from clinical study.

Also known as: Capecitabine

GB221+ Capecitabine tablets

Placebo control

Eligibility Criteria

Age18 Years - 70 Years

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

Aged 18 to 70 years;
Pathologically confirmed as advanced breast cancer and there is at least one measurable target lesion (based on RECIST V1.1):

Sponsors & Collaborators

Genor Biopharma Co., Ltd.
Industrylead

Study Sites (1)

People's Liberation Army General Hospital The Fifth Medical Center

Beijing, Beijing Municipality, 100071, China

RECRUITING

Ze Fei Jiang, Ph.DCONTACT010-66947171 jiangzefei@medmail.com

Ze Fei Jiang, Ph.DPRINCIPAL INVESTIGATOR

MeSH Terms

Interventions

Capecitabine

Intervention Hierarchy (Ancestors)

DeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsFluorouracilUracilPyrimidinonesDeoxyribonucleosidesNucleosidesNucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Shawn Yu, Master

CONTACT

18600332657 shawn.yu@genorbio.com

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: TREATMENT
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 15, 2019

Study Start

November 24, 2016

Actual (reported)

Primary Completion

July 2020

Estimated (date passed)

You may not qualify if:

Pregnant or breastfeeding females; or women of childbearing potential who have positive serum/urine pregnancy tests; females of childbearing potential and their partners are unwilling to adopt effective contraceptive methods during the clinical study period and within 6 months after the end of the study;
Received radiotherapy or chemotherapy within 4 weeks before randomization;
Received anti-tumor endocrine therapy within 2 weeks before randomization;
Previously received the standard anti-HER-2 treatment;
Previously received capecitabine treatment;
Subjects who previously received no taxanes; or subjects who respond to taxanes (no disease progression or intolerable toxic reactions);
The major organ function of subjects is abnormal. The laboratory test results are presented below:
Hematology test:
l Absolute neutrophil count (ANC) \< 1.5×109/L; l Platelet count (PLT) \<100×109/L; l Hemoglobin (Hb) \< 90 g/L (no blood transfusion within 14 days);
Hepatic and renal function tests:
l Bilirubin (TBIL)\>1.5×ULN (upper limit of normal); l Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)\>2.5×ULN; if there is any hepatic metastasis, ALT and AST \>5×ULN; l Serum creatinine (Cr) \>1.5×ULN; 8. Left ventricular ejection fraction ( LVEF)\<50%; 9. The organ system status of subjects:
Subjects with known or suspected brain metastasis: subjects with evidence indicating signs or symptoms of brain metastasis are not allowed to participate in this study unless such brain metastasis is excluded by CT or MRI. However, subjects whose brain metastasis lesions have been controlled can be enrolled (no progression within at least 4 weeks after radiotherapy and/or no neurological symptom or sign after surgical resection, treatment with dexamethasone or mannitol is not necessary);
Evidence showing severe or uncontrolled systemic diseases (e.g. unstable or non-compensated respiratory, cardiac, hepatic or renal disease);
Uncontrolled active infection (≥CTCAE grade 2); l Any other malignant tumor within 5 years, excluding patients with completely cured cervical in situ carcinoma or basal cell or squamous epithelial cell skin cancer);
Subjects who have any of the following cardiac conditions:
+6 more criteria

Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

GB221+ Capecitabine tablets

Placebo control + capecitabine tablets

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (2)

GB221+ Capecitabine tablets

Placebo control + capecitabine tablets

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations