A Safety and Efficacy Study of BCD-022 With Paclitaxel Compared to Herceptin With Paclitaxel in HER2+ Metastatic Breast Cancer Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01764022
• Date of registration: 07/01/2013
• Prospective Registration: No
• Primary sponsor: Biocad
• Public title: A Safety and Efficacy Study of BCD-022 With Paclitaxel Compared to Herceptin With Paclitaxel in HER2+ Metastatic Breast Cancer Patients
• Scientific 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
• Date of first enrolment: October 2012
• Target sample size: 225
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01764022
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Belarus, India, Russian Federation, Ukraine

Contacts

• Name: Roman Ivanov, MD, PhD
• Affiliation: Vice-president, R&D

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Female

Health Condition(s) or Problem(s) studied

Human Epithelial Receptor (HER)-2 Positive Breast Cancer

Intervention(s)

Drug: Paclitaxel

Drug: Trastuzumab

Primary Outcome(s)

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)]

Overall Response Rate [Time Frame: Day 127]

Secondary Outcome(s)

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]

Progression Rate [Time Frame: Day 127]

Stabilization Rate [Time Frame: Day 127]

Tmax After the Sixth Test Drug Administration [Time Frame: Up to Day 127]

Treatment Discontinuation Due to AE/SAE [Time Frame: Day 127]

Complete Response Rate [Time Frame: Day 127]

Tmax After the First Test Drug Administration [Time Frame: Up to Day 22]

Treatment Postponed Due to AE/SAE [Time Frame: Day 127]

Cmax After the Sixth Test Drug Administration [Time Frame: Up to Day 127]

Partial Response Rate [Time Frame: Day 127]

T1/2 After the First Test Drug Administration [Time Frame: Up to Day 22]

Secondary ID(s)

BCD-022-02

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 24/10/2016
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01764022