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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
225
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).
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).
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
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)
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
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.
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Brest Region Clinical Oncology Dispensary
Brest, Belarus
Grodno Regional Hospital
Grodno, Belarus
Gomel Region Clinical Oncology Dispensary
Homyel, Belarus
Vitebsk State Medical University of Order of Peoples' Friendship
Vitebsk, Belarus
HCG Bangalore Institute of Oncology
Bangalore, India
M.S.Ramaiah Memorial Hospital
Bangalore, India
Narayana Hrudayalaya Hospitals
Bangalore, India
State Health Institution of Moscow "Moscow City Oncology Hospital #62 of Moscow Board of Health"
Stepanovskoye, Moscow Oblast, Russia
Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, Russia
Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"
Chelyabinsk, Russia
...and 26 more locations
Time frame: Day 127
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
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
Treatment Postponed Due to AE/SAE
Secondary outcome measure for safety evaluation
Time frame: Day 127
Treatment Discontinuation Due to AE/SAE
Secondary outcome measure for safety evaluation
Time frame: Day 127
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
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
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
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
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
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