HER-2-positive Advanced Breast CancerPhase 3NCT04164615
Clinical Study of Recombinant Anti-HER2 Humanized Monoclonal Antibody (GB221) for Injection
A Phase 3 study testing GB221 in people with HER-2-positive Advanced Breast Cancer, run by Genor Biopharma Co., Ltd. at 1 site in China.
Trial summary
The primary objective of this trial is to compare the progression-free survival (PFS) in two groups of combined therapy of GB221/ capecitabine tablets versus combined therapy of placebo/capecitabine tablets; the secondary objective is to evaluate the objective response rate (ORR),time to progression (TTP) from… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- HER-2-positive Advanced Breast Cancer
- What is being tested?
- GB221
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 336 participants
- Where
- 1 siteChina
- Study dates
- 24 Nov 2016to Nov 2020
- Phase
- Phase 3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- l According to Response Evaluation Criteria in Solid Tumors, the target lesions must be accurately measured in at least one dimension; l No previous radiotherapy, intervention for target lesions;
- HER-2 positive [definition: including IHC (+++) or ISH positive; if IHC (++), HER-2 gene amplification detection should be further performed through fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH),silver-enhanced in situ hybridization (SISH) and other methods. The test reports of the clinical study site associated with the subject should be provided];
- The relapsed or metastatic patients who failed respond to the previous taxanes and/or anthracyclines, previous first-line chemotherapy for the metastatic lesion is acceptable;
- The expected survival is 3 months or longer;
Show all 31Show fewer
- The function of major organs such as heart, liver and kidney are basically normal;
- ECOG score ≤2;
- Understand and voluntarily sign the written informed consent form;
- 2 Exclusion Criteria
- 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:
- 1 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);
- 1 Evidence showing severe or uncontrolled systemic diseases (e.g. unstable or non-compensated respiratory, cardiac, hepatic or renal disease);
- 1 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);
- 1 Subjects who have any of the following cardiac conditions:
- Unstable angina pectoris;
- Medical history of congestive heart failure;
- Previous medical history of myocardial infarction, coronary artery bypass grafting or coronary stent implantation;
- Clinically significant pericardial diseases and valvular heart diseases;
- Cardiac arrhythmias requiring therapeutic intervention;
- Any other cardiac diseases which may cause safety risks for subjects if they are enrolled in this study; 1 Uncontrolled hypertension (defined as screening systolic blood pressure ≥ 180mmHg and/or diastolic blood pressure ≥110mmHg); 10. Immunodeficiency medical history, including positive HIV detection; 11. Positive hepatitis B surface antigen (HBsAg) and hepatitis B virus DNA of peripheral blood is not within the normal range; Positive hepatitis C virus antibody (HCV); 12. Subjects with drug abuse history or alcohol addiction history; 13. Participated in clinical study with drug intervention within one month before screening; 14. Subjects who are unsuitable for participation in this study at the discretion of the investigators.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
People's Liberation Army General Hospital The Fifth Medical Center
Beijing, Beijing Municipality, 100071
Ze Fei Jiang, Ph.D, 010-66947171, jiangzefei@medmail.com
Ze Fei Jiang, Ph.D
About this study
Official title: A Randomized, Double-blind, Multi-center Phase Ⅲ Clinical Study to Evaluate the Recombinant Anti-HER2 Humanized Monoclonal Antibody or Placebo in Combination With Capecitabine for the Treatment of HER-2-positive Advanced Breast Cancer
The primary objective of this trial is to compare the progression-free survival (PFS) in two groups of combined therapy of GB221/ capecitabine tablets versus combined therapy of placebo/capecitabine tablets; the secondary objective is to evaluate the objective response rate (ORR),time to progression (TTP) from treatment period to week 12; overall survival (OS), safety, immunogenicity (anti-drug antibody), PFS of subjects during continued treatment period.
- Conditions
- HER-2-positive Advanced Breast Cancer
- Being tested
- GB221, Placebo control
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GB221Drug
Also called Capecitabine
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.
Placebo controlDrug
Also called capecitabine
Placebo control: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.
| Study group | Role | What they receive |
|---|---|---|
| GB221+ Capecitabine tablets | Experimental | test drug+capecitabine Receives: Drug: GB221 |
| Placebo control + capecitabine tablets | Placebo comparator | placebo+capecitabine Receives: Drug: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free survival, PFS
To evaluate the efficacy of GB221 as defined by progression-free survival in patients with breast cancer.
Measured: through study completion, an average of 2 year
Secondary outcomes (4)
Objective Response Rate, ORR
To evaluate the efficacy of GB221 as defined by overall response rate, in patients with breast cancer.
Measured: through study completion, an average of 2 year
Antidrug antibody, ADA
Antidrug antibody, ADA
Measured: through study completion, an average of 2 year
Overall survival, OS
To evaluate the duration from the first administration to death because of any reason in patients with breast cancer.
Measured: through study completion, an average of 2 year
PFS in the extended treatment phase
PFS in the extended treatment phase
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start24 Nov 2016
- Primary completionJul 2020 (estimated)
- Study completionNov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER-2-positive Advanced 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 336 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genor Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164615
- Sponsor's protocol ID
- GENOR GB221-003；V1.1
- Status last verified
- Nov 2019
- First submitted
- 13 Nov 2019
- Last updated
- 15 Nov 2019
- 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 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Multi-center Phase Ⅲ Clinical Study to Evaluate the Recombinant Anti-HER2 Humanized Monoclonal Antibody or Placebo in Combination With Capecitabine for the Treatment of HER-2-positive Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT04164615
- Acronym / sponsor ID
- GENOR GB221-003；V1.1
- Conditions
- HER-2-positive Advanced Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 336 participants (estimated)
- Lead sponsor
- Genor Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Nov 2016 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Nov 2020 (estimated)
- First posted
- 15 Nov 2019 (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.
The primary objective of this trial is to compare the progression-free survival (PFS) in two groups of combined therapy of GB221/ capecitabine tablets versus combined therapy of placebo/capecitabine tablets; the secondary objective is to evaluate the objective response rate (ORR),time to progression (TTP) from treatment period to week 12; overall survival (OS), safety, immunogenicity (anti-drug antibody), PFS of subjects during continued treatment period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GB221+ Capecitabine tablets | Experimental | Drug: GB221test drug+capecitabine |
| Placebo control + capecitabine tablets | Placebo comparator | Drug: Placebo controlplacebo+capecitabine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (31 listed)
- 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):
- l According to Response Evaluation Criteria in Solid Tumors, the target lesions must be accurately measured in at least one dimension; l No previous radiotherapy, intervention for target lesions;
- HER-2 positive [definition: including IHC (+++) or ISH positive; if IHC (++), HER-2 gene amplification detection should be further performed through fluorescence in situ hybridization (FISH) or chromogenic in situ hybridization (CISH),silver-enhanced in situ hybridization (SISH) and other methods. The test reports of the clinical study site associated with the subject should be provided];
- The relapsed or metastatic patients who failed respond to the previous taxanes and/or anthracyclines, previous first-line chemotherapy for the metastatic lesion is acceptable;
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| GB221Also: CapecitabineGB221: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. | Drug | GB221+ Capecitabine tablets |
| Placebo controlAlso: capecitabinePlacebo control: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. | Drug | Placebo control + capecitabine tablets |
Primary outcome
Progression-free survival, PFS
Time frame: through study completion, an average of 2 year
To evaluate the efficacy of GB221 as defined by progression-free survival in patients with breast cancer.
4 secondary outcomes
Objective Response Rate, ORR
Time frame: through study completion, an average of 2 year
Antidrug antibody, ADA
Time frame: through study completion, an average of 2 year
Overall survival, OS
Time frame: through study completion, an average of 2 year
PFS in the extended treatment phase
Time frame: through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2019.
- 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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing GB221 in people with HER-2-positive Advanced Breast Cancer, run by Genor Biopharma Co., Ltd. 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 31 inclusion and 0 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: status not confirmed, as of the sponsor's last update on 15 Nov 2019. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shawn Yu, Master (18600332657, shawn.yu@genorbio.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: through study completion, an average of 2 year). 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 15 Nov 2019.