Human Epithelial Receptor (HER)-2 Positive Breast CancerPhase 3NCT01764022
A Safety and Efficacy Study of BCD-022 With Paclitaxel Compared to Herceptin With Paclitaxel in HER2+ Metastatic Breast Cancer Patients
A Phase 3 study testing Trastuzumab and Paclitaxel in people with Human Epithelial Receptor (HER)-2 Positive Breast Cancer, run by Biocad at 36 sites in 4 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Human Epithelial Receptor (HER)-2 Positive Breast Cancer
- What is being tested?
- Trastuzumab and Paclitaxel
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 36 sitesin 4 countries
- Study dates
- Oct 2012to Dec 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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) ;
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- 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.
Who cannot join
- 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;
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- 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
Trial locations and contacts
36 sites in 4 countries.
36 sites in 4 countries
Russia20 sites
Arkhangelsk District Clinical Oncology Dispensary
Arkhangelsk, 163045
Non-governmental Healthcare Institution "Railway Clinical hospital on the Chelyabinsk Station of JSC Russian Railways"
Chelyabinsk, 355047
State-financed Health Institution "Chelyabinsk Region Clinical Oncology Dispansary"
Chelyabinsk, 454087
State-financed Health Institution "Republican Clinical Oncology Hospital"
Izhevsk, 426009
Institution of Russian Academy of Medical Sciences "Russian Cancer Research Center named after N.N. Blokhin"
Moscow, 115478
Federal State Institution "Moscow Institute of Cancer Research named after P.A. Hertsen" Ministry of Health of Russian Federation
Moscow, 125284
Regional State Health Institution "Orlov Oncology Dispansary"
Oryol, 302020
State Health Institution "Region Oncology Dispansary"
Penza, 440071
Perm Region Oncology Dispensary
Perm, 614066
Federal Government Budgetary Institution "Rostov Institute of Cancer Research" of Ministry of Health of Russian Federation
Rostov-on-Don, 314019
Military Medical Academy named after S.M. Kirov
Saint Petersburg, 194044
Saint Petersburg City Clinical Oncology Center
Saint Petersburg, 197022
N.N.Petrov Oncology Research Center
Saint Petersburg, 197758
Russian scientific center of radiology and surgery technologies
Saint Petersburg
State-financed Health Institution "Samara Region Clinical Oncology Dispansary"
Samara, 443031
Oncology Dispensary 2
Sochi, 354057
State-financed Health Institution "Stavropol Region Clinical Oncology Dispansary"
Stavropol, 355047
State Health Institution of Moscow "Moscow City Oncology Hospital #62 of Moscow Board of Health"
Stepanovskoye, Moscow Oblast, 143423
Republican Clinical Oncology Dispensary of Ministry of Health republic Bashkortostan
Ufa, 450054
Volgograd District Oncology Dispensary №1
Volgograd, 400138
Ukraine9 sites
Donetsk City Oncology Dispensary
Donetsk
Donetsk Regional Antitumor Center
Donetsk
Kharkiv Regional Clinical Oncology Center
Kharkiv
Kryvyi Rih Oncology Dispensary
Kryvyi Rih
Lviv Regional State Cancer Diagnostics and Treatment Center
Lviv
City Hospital №2
Makiivka
Poltava Regional Clinical Oncology Dispensary
Poltava
Zakarpatskyi Regional Clinical Oncology Center
Uzhhorod
Vinnytsia Regional Clinical Oncology Dispensary
Vinnytsia
Belarus4 sites
Brest Region Clinical Oncology Dispensary
Brest
Grodno Regional Hospital
Grodno
Gomel Region Clinical Oncology Dispensary
Homyel
Vitebsk State Medical University of Order of Peoples' Friendship
Vitebsk
India3 sites
HCG Bangalore Institute of Oncology
Bangalore, 560027
M.S.Ramaiah Memorial Hospital
Bangalore, 560054
Narayana Hrudayalaya Hospitals
Bangalore, 560099
About this study
Official title: Multicenter Randomized Double-blind Phase III Clinical Trial Comparing Safety and Efficacy of BCD-022 (CJSC BIOCAD, Russia) Used With Paclitaxel to Herceptin® Used With Paclitaxel in the First-line Treatment of HER2+ Metastatic Breast Cancer Patients
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.
Read the 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.
- Being tested
- Trastuzumab, Paclitaxel
- Keywords
- breast cancer, trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
Also called BCD-022, Herceptin
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).
PaclitaxelDrug
Also called Taxacad
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).
| Study group | Role | What they receive |
|---|---|---|
| BCD-022 | Experimental | 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). Receives: Drug: Trastuzumab; Drug: Paclitaxel |
| Herceptin® | Active comparator | In this arm patients will receive 6 courses of treatment with Herceptin® (F. Hoffmann-La Roche Ltd., Switzerland) 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). Receives: Drug: Trastuzumab; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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)
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Day 127
Treatment Postponed Due to AE/SAE
Secondary outcome measure for safety evaluation
Measured: Day 127
Treatment Discontinuation Due to AE/SAE
Secondary outcome measure for safety evaluation
Measured: 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.
Measured: 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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Up to Day 127
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2015
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Human Epithelial Receptor (HER)-2 Positive 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Biocad
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Roman Ivanov, MD, PhD, Study chair, Vice-president, R&D
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01764022
- Sponsor's protocol ID
- BCD-022-02
- Status last verified
- Nov 2018
- First submitted
- 7 Jan 2013
- Last updated
- 29 Nov 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Alexeev SM, Khorinko AV, Mukhametshina GZ, Shelepen KG, Burdaeva ON, Kulik SA, Satheesh CT, Srivastava K, Vikranth M, Kryukov F, Paltusova AN, Shustova MS, Ivanov RA. Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-022 with reference trastuzumab. BMC Cancer. 2020 Aug 20;20(1):783. doi: 10.1186/s12885-020-07247-9.
PubMed 32819305
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Double-blind Phase III Clinical Trial Comparing Safety and Efficacy of BCD-022 (CJSC BIOCAD, Russia) Used With Paclitaxel to Herceptin® Used With Paclitaxel in the First-line Treatment of HER2+ Metastatic Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01764022
- Acronym / sponsor ID
- BCD-022-02
- Keywords
- breast cancer, trastuzumab
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- BiocadIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Mar 2015 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 9 Jan 2013 (estimated)
- Results
- Posted 24 Oct 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BCD-022 | Experimental | Drug: Trastuzumab, Drug: PaclitaxelBCD-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). |
| Herceptin® | Active comparator | Drug: Trastuzumab, Drug: PaclitaxelIn this arm patients will receive 6 courses of treatment with Herceptin® (F. Hoffmann-La Roche Ltd., Switzerland) 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). |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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);
Key exclusion criteria (23 listed)
- 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;
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 |
|---|---|---|
| TrastuzumabAlso: BCD-022, HerceptinPatients 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). | Drug | BCD-022, Herceptin® |
| PaclitaxelAlso: TaxacadPaclitaxel 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). | Drug | BCD-022, Herceptin® |
Primary outcome
Overall Response Rate
Time frame: 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
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)
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.
12 secondary outcomes
Complete Response Rate
Time frame: Day 127
Partial Response Rate
Time frame: Day 127
Stabilization Rate
Time frame: Day 127
Progression Rate
Time frame: Day 127
Treatment Postponed Due to AE/SAE
Time frame: Day 127
Treatment Discontinuation Due to AE/SAE
Time frame: Day 127
Occurrence of Neutralizing Anti-trastuzumab Antibodies
Time frame: Day 1 (before the drug administration), Day 14, 64, 127 and 154
Cmax After the First Test Drug Administration
Time frame: Up to Day 22
Tmax After the First Test Drug Administration
Time frame: Up to Day 22
T1/2 After the First Test Drug Administration
Time frame: Up to Day 22
Cmax After the Sixth Test Drug Administration
Time frame: Up to Day 127
Tmax After the Sixth Test Drug Administration
Time frame: Up to Day 127
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32819305Alexeev SM, Khorinko AV, Mukhametshina GZ, Shelepen KG, Burdaeva ON, Kulik SA, Satheesh CT, Srivastava K, Vikranth M, Kryukov F, Paltusova AN, Shustova MS, Ivanov RA. Randomized double-blind clinical trial comparing safety and efficacy of the biosimilar BCD-022 with reference trastuzumab. BMC Cancer. 2020 Aug 20;20(1):783. doi: 10.1186/s12885-020-07247-9.
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.
Roman Ivanov, MD, PhD study chair
Vice-president, R&D
36 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Trastuzumab and Paclitaxel in people with Human Epithelial Receptor (HER)-2 Positive Breast Cancer, run by Biocad at 36 sites in 4 countries.
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 11 inclusion and 23 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: finished, as of the sponsor's last update on 29 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in Russia, Ukraine, Belarus, India. 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. 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?
Yes. Results are posted in the registry (first posted 24 Oct 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Response Rate (time frame: Day 127). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01764022, which also lists 1 linked publication.
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 29 Nov 2018.