Human Epithelial Receptor (HER)-2 Positive Breast Cancer
Conditions
Keywords
breast cancer, trastuzumab
Brief summary
BCD-022-02 is a double-blind randomized clinical trial comparing efficacy of BCD-022 (INN: trastuzumab) and paclitaxel to Herceptin and paclitaxel in HER2-positive metastatic breast cancer with pharmacokinetics substudy. The purpose of the study is to demonstrate the non-inferiority of efficacy and safety of BCD-022 compared to Herceptin. Also study includes pharmacokinetics assessment.
Detailed description
The study is based on the hypothesis of equivalence of BCD-022 (trastuzumab by JSC BIOCAD, Russia) in combination with paclitaxel used as the therapy of inoperable or metastatic HER2(+) breast cancer in comparison with Herceptin® (F. Hoffmann-La Roche Ltd., Switzerland) in combination with paclitaxel. The objectives of the study is to evaluate efficacy, safety and pharmacokinetics of BCD-022 compared with reference trastuzumab by 1. overall response rate and other efficacy parameters; 2. incidence and severity of adverse events; 3. serum concentration after the first and multiple trastuzumab administration; 4. incidence and concentration of anti-trastuzumab antibodies.
Interventions
DRUGTrastuzumab
Patients will receive 6 courses of trastuzumab in combination with paclitaxel. Trastuzumab will be administered at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations) as 90 min intravenous infusion every 3 weeks (on Day 1 of each cycle).
DRUGPaclitaxel
Paclitaxel will be administered at a dose of 175 mg/m2 every 3 weeks (on Day 1 of each course) as 3 hour intravenous infusion (6 courses totally).
Sponsors
Biocad
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Written informed consent and ability to follow the Protocol procedures; * Age from 18 years to 75 years inclusive; * Female gender; * Histologically confirmed breast cancer (BC); * Metastatic BC (stage IV according to TNM classification version 6); * Grade 3+ HER2 overexpression confirmed by immunohistochemical (IHC) staining or grade 2+ HER2 overexpression accompanied by HER2 gene amplification confirmed by fluorescent hybridization in situ (FISH) ; * Documented results of oestrogen and progesterone receptors expression analysis; * Eastern Cooperative Oncology Group (ECOG) status 0, 1 or 2, not increasing within 2 weeks prior to randomization; * Life expectancy - 20 weeks or more from the moment of randomization; * Presence of at least 1 tumour with a size not less than 1 cm (revealed with computed tomography (CT) slice thickness not more than 5 mm). Patients having bone metastasis as the only measurable tumour are not eligible for the trial; * Patients of childbearing potential must implement reliable contraceptive measures during the study treatment, starting 4 weeks prior to inclusion into the trial and until 6 months after the last administration of the study drug.
Exclusion criteria
* Previous anticancer therapy for metastatic BC, including cytotoxic chemotherapy, or previous anticancer therapy with signal transduction inhibitors (e.g. lapatinib), biological drugs (e.g. trastuzumab, bevacizumab), experimental (not approved for BC therapy) anticancer drugs. Any previous hormonal therapy is allowed; * Disease progression within 6 months after adjuvant and/or neoadjuvant anti BC therapy; * Surgery, radiation therapy, use of any experimental medications within 4 weeks (28 days) prior to randomization; * Hypersensitivity to paclitaxel and all medications containing polyoxyethylated castor oil, hypersensitivity to dexamethasone, diphenhydramine, ranitidine/cimetidine, recombinant murine proteins, contrast agents or excipients of study medications; * BC metastases in central nervous system, progressing or clinically manifested (e.g. cerebral oedema, spinal cord injury), with exception of non-progressing metastases not requiring treatment with glucocorticosteroids and/or anticonvulsants within 4 weeks prior to randomization; * Cardiovascular system pathology (congestive heart failure (CHF) stage III-IV according to New York Heart Association (NYHA) classification, unstable angina pectoris, myocardial infarction) within 12 months prior to randomization; * Uncontrolled hypertension comprising all cases of arterial hypertension when no decrease in blood pressure could be achieved despite treatment with a combination of 3 antihypertensive drugs including one diuretic and non-medicamental correction methods (low salt diet, physical exercise); * Left ventricular ejection fraction \<50% according to electrocardiography; * Neutrophils ≤1500/mm3; * Platelets ≤100 000/mm3; * Hemoglobin ≤90 g/L; * Creatinine level ≥ 1.5 × upper limit of normal (ULN); * Bilirubin level ≥ 1.5 × ULN; * Asparagine transferase (AST) and alanine transferase (ALT) levels ≥ 2.5 × ULN (5 × ULN for patients with liver metastases); * Alkaline phosphatase level ≥ 5 × ULN; * Pregnancy or lactation; * Any other concomitant cancer including contralateral breast cancer revealed within 5 years prior to screening, except curatively treated intraductal carcinoma in situ, curatively treated cervical carcinoma in situ or curatively treated basal cell or squamous cell carcinoma; * Conditions limiting patient's adherence to protocol requirements (dementia, neurologic or psychiatric disorders, drug addiction, alcoholism and others); * Stage II-IV neuropathy according to Common Terminology Criteria for Adverse Events (CTCAE) v.4.0; * Concomitant participation in other clinical trials, previous participation in other clinical trials within 30 days before entering into the trial, previous participation in the same trial; * Acute or active chronic infections; * Hepatitis C virus, hepatitis B virus, HIV or syphilis infections; * Obstacles in intravenous administration of study drugs
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall Response Rate | Day 127 | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed. |
| Area Under the Curve After the First Test Drug Administration | up to Day 22, after the first trastuzumab administration (time points for blood samples: 0 h 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h) | Primary outcome measure for pharmacokinetics (PK) substudy. AUC(0-504) of trastuzumab in HER2(+) mBC patients after first administration of BCD-022 with paclitaxel or Herceptin® with paclitaxel. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stabilization Rate | Day 127 | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed. |
| Progression Rate | Day 127 | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed. |
| Treatment Postponed Due to AE/SAE | Day 127 | Secondary outcome measure for safety evaluation |
| Treatment Discontinuation Due to AE/SAE | Day 127 | Secondary outcome measure for safety evaluation |
| Occurrence of Neutralizing Anti-trastuzumab Antibodies | Day 1 (before the drug administration), Day 14, 64, 127 and 154 | Secondary outcome measure for immunogenicity assessment. Patient was suggested as NAB-positive if neutralizing anti-trastuzumab antibodies were detected at any of the specified timepoints. Total number of NAB-positive patients in each are presented. |
| Complete Response Rate | Day 127 | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed. |
| Tmax After the First Test Drug Administration | Up to Day 22 | Secondary outcome measure for PK substudy. Time to reach peak serum concentration of trastuzumab after the first administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel |
| T1/2 After the First Test Drug Administration | Up to Day 22 | Secondary outcome measure for PK substudy. Half-life period of trastuzumab after the first administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel. |
| Cmax After the Sixth Test Drug Administration | Up to Day 127 | Secondary outcome measure for PK substudy. Peak serum concentration of trastuzumab after the sixth administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel. |
| Tmax After the Sixth Test Drug Administration | Up to Day 127 | Secondary outcome measure for PK substudy. Time to reach peak serum concentration of trastuzumab after the sixth administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel |
| Cmax After the First Test Drug Administration | Up to Day 22 | Secondary outcome measure for PK substudy. Peak serum concentration of trastuzumab after single administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel |
| Partial Response Rate | Day 127 | Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed. |
Countries
Belarus, India, Russia, Ukraine
Participant flow
Pre-assignment details
In BCD-022 group 2 patients were exluded from any analysis due to: * Death prior to the first drug administration * Informed consent withdrawal prior to the first drug administration
Participants by arm
| Arm | Count |
|---|---|
| BCD-022 (CJSC BIOCAD) BCD-022 is a product code for trastuzumab biosimilar manufactured by CJSC BIOCAD, Russia. In this arm patients will receive 6 courses of treatment with BCD-022 in combination with paclitaxel. Patients will receive BCD-022 at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations). | 115 |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) In this arm patients will receive 6 courses of treatment with Herceptin in combination with paclitaxel. Patients will receive Herceptin at a loading dose of 8 mg/kg (once), followed by maintenance dose of 6 mg/kg every 3 weeks (5 administrations), + paclitaxel 175 mg/m2 every 3 weeks as 3 hour intravenous infusion (6 administrations). | 110 |
| Total | 225 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 3 | 5 |
| Overall Study | Lack of Efficacy | 0 | 1 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Physician Decision | 0 | 2 |
| Overall Study | Protocol Violation | 1 | 0 |
| Overall Study | Withdrawal by Subject | 2 | 6 |
Baseline characteristics
| Characteristic | Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Total | BCD-022 (CJSC BIOCAD) |
|---|---|---|---|
| Age, Continuous | 50.573 years STANDARD_DEVIATION 9.877 | 50.63 years STANDARD_DEVIATION 10.415 | 50.687 years STANDARD_DEVIATION 10.948 |
| HER2 Expression HER2 ++ | 13 Participants | 27 Participants | 14 Participants |
| HER2 Expression HER2 +++ | 97 Participants | 197 Participants | 100 Participants |
| HER2 Expression Unknown | 0 Participants | 1 Participants | 1 Participants |
| Histologic type of cancer Ductal | 33 Participants | 69 Participants | 36 Participants |
| Histologic type of cancer Lobular | 18 Participants | 41 Participants | 23 Participants |
| Histologic type of cancer Medullar | 4 Participants | 7 Participants | 3 Participants |
| Histologic type of cancer Micropapillary | 0 Participants | 1 Participants | 1 Participants |
| Histologic type of cancer Mucinouse | 5 Participants | 8 Participants | 3 Participants |
| Histologic type of cancer Tubular | 37 Participants | 72 Participants | 35 Participants |
| Histologic type of cancer Unknown histilogic type | 13 Participants | 27 Participants | 14 Participants |
| Sex: Female, Male Female | 110 Participants | 225 Participants | 115 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 3 / 113 | 5 / 110 |
| other Total, other adverse events | 106 / 113 | 104 / 110 |
| serious Total, serious adverse events | 8 / 113 | 13 / 110 |
Outcome results
Primary
Area Under the Curve After the First Test Drug Administration
Primary outcome measure for pharmacokinetics (PK) substudy. AUC(0-504) of trastuzumab in HER2(+) mBC patients after first administration of BCD-022 with paclitaxel or Herceptin® with paclitaxel.
Time frame: up to Day 22, after the first trastuzumab administration (time points for blood samples: 0 h 1.5 h, 3 h, 4.5 h, 6 h, 24 h, 96 h, 168 h, 336 h and 504 h)
Population: Patients who received one dose of study drug and after 504 hours after the injection had missed \<= 1 blood sample collection to analyse pharmacokinetics.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | Area Under the Curve After the First Test Drug Administration | 28969372.5 (ng/ml)*hour |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Area Under the Curve After the First Test Drug Administration | 28796527.9 (ng/ml)*hour |
Primary
Overall Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed.
Time frame: Day 127
Population: The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | Overall Response Rate | 56 Participants |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Overall Response Rate | 48 Participants |
Secondary
Cmax After the First Test Drug Administration
Secondary outcome measure for PK substudy. Peak serum concentration of trastuzumab after single administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel
Time frame: Up to Day 22
Population: Patients who received one dose of study drug and after 504 hours after the injection had missed \<= 1 blood sample collection to analyse pharmacokinetics.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | Cmax After the First Test Drug Administration | 218720.0 ng/ml |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Cmax After the First Test Drug Administration | 216710.0 ng/ml |
Secondary
Cmax After the Sixth Test Drug Administration
Secondary outcome measure for PK substudy. Peak serum concentration of trastuzumab after the sixth administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel.
Time frame: Up to Day 127
Population: Patients who received six dose of study drug and had missed \<= 1 blood sample collection to analyse pharmacokinetics.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | Cmax After the Sixth Test Drug Administration | 168735.0 ng/ml |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Cmax After the Sixth Test Drug Administration | 169220.0 ng/ml |
Secondary
Complete Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed.
Time frame: Day 127
Population: The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | Complete Response Rate | 4 Participants |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Complete Response Rate | 2 Participants |
Secondary
Occurrence of Neutralizing Anti-trastuzumab Antibodies
Secondary outcome measure for immunogenicity assessment. Patient was suggested as NAB-positive if neutralizing anti-trastuzumab antibodies were detected at any of the specified timepoints. Total number of NAB-positive patients in each are presented.
Time frame: Day 1 (before the drug administration), Day 14, 64, 127 and 154
Population: Patients who received at least one injection of study drug
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | Occurrence of Neutralizing Anti-trastuzumab Antibodies | 3 participants |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Occurrence of Neutralizing Anti-trastuzumab Antibodies | 4 participants |
Secondary
Partial Response Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed.
Time frame: Day 127
Population: The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | Partial Response Rate | 52 Participants |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Partial Response Rate | 46 Participants |
Secondary
Progression Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed.
Time frame: Day 127
Population: The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | Progression Rate | 25 Participants |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Progression Rate | 28 Participants |
Secondary
Stabilization Rate
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. The response was assessed at the screening, after 3 therapy cycles and after 6 therapy cycles. If CT after 3 or 6 therapy cycles revealed the complete or partial response, a confirmatory CT scan was performed 4 weeks later. The best response during the study was assessed.
Time frame: Day 127
Population: The population for efficacy analysis included patients who received at least one injection of study drug and had evaluable results of treatment.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | Stabilization Rate | 28 Participants |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Stabilization Rate | 21 Participants |
Secondary
T1/2 After the First Test Drug Administration
Secondary outcome measure for PK substudy. Half-life period of trastuzumab after the first administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel.
Time frame: Up to Day 22
Population: Patients who received one dose of study drug and after 504 hours after the injection had missed \<= 1 blood sample collection to analyse pharmacokinetics.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | T1/2 After the First Test Drug Administration | 162.1 hours |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | T1/2 After the First Test Drug Administration | 160.6 hours |
Secondary
Tmax After the First Test Drug Administration
Secondary outcome measure for PK substudy. Time to reach peak serum concentration of trastuzumab after the first administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel
Time frame: Up to Day 22
Population: Patients who received one dose of study drug and after 504 hours after the injection had missed \<= 1 blood sample collection to analyse pharmacokinetics.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | Tmax After the First Test Drug Administration | 160.6 hours |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Tmax After the First Test Drug Administration | 162.1 hours |
Secondary
Tmax After the Sixth Test Drug Administration
Secondary outcome measure for PK substudy. Time to reach peak serum concentration of trastuzumab after the sixth administration of BCD-022 + paclitaxel or Herceptin® + paclitaxel
Time frame: Up to Day 127
Population: Patients who received six dose of study drug and had missed \<= 1 blood sample collection to analyse pharmacokinetics.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | Tmax After the Sixth Test Drug Administration | 185.8 hour |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Tmax After the Sixth Test Drug Administration | 192.9 hour |
Secondary
Treatment Discontinuation Due to AE/SAE
Secondary outcome measure for safety evaluation
Time frame: Day 127
Population: Patients who received at least one injection of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | Treatment Discontinuation Due to AE/SAE | 0 participants |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Treatment Discontinuation Due to AE/SAE | 1 participants |
Secondary
Treatment Postponed Due to AE/SAE
Secondary outcome measure for safety evaluation
Time frame: Day 127
Population: Patients who received at least one injection of study drug.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| BCD-022 (CJSC BIOCAD) | Treatment Postponed Due to AE/SAE | 4 participants |
| Herceptin ® (F. Hoffmann-La Roche Ltd., Switzerland) | Treatment Postponed Due to AE/SAE | 5 participants |