Comparing BCD-178 and Perjeta for treating HER2-positive breast cancer
A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer
PHASE3 · Biocad · NCT05802225
This study is testing whether a new treatment called BCD-178 works better than Perjeta for shrinking tumors in patients with HER2-positive breast cancer before surgery.
Quick facts
| Phase | PHASE3 |
|---|---|
| Study type | Interventional |
| Enrollment | 374 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | Female |
| Sponsor | Biocad (industry) |
| Drugs / interventions | trastuzumab |
| Locations | 3 sites (Moscow and 2 other locations) |
| Trial ID | NCT05802225 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the efficacy and safety of two treatments, BCD-178 and Perjeta, as neoadjuvant therapy for patients with HER2-positive invasive breast cancer. Participants with confirmed diagnoses will be randomly assigned to receive either BCD-178 or Perjeta in a 1:1 ratio. The study focuses on patients with stage II-III breast cancer who do not express estrogen or progesterone receptors. The goal is to determine which treatment is more effective in shrinking tumors before surgery.
Who should consider this trial
Good fit: Ideal candidates include women with stage II-III HER2-positive invasive breast cancer who are ER and PR negative.
Not a fit: Patients with stage IV breast cancer or those who have previously received systemic therapy for breast cancer may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a more effective neoadjuvant treatment option for patients with HER2-positive breast cancer.
How similar studies have performed: Other studies have shown promising results with similar HER2-targeted therapies, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Signed informed consent ; * Histologically confirmed diagnosis of invasive breast cancer; * Disease stage cT2-cT4, cN0-cN3, cM0; * Positive HER2 expression, negative estrogen and progesterone receptor expression; * ECOG score 0-1; * Adequate organ function; * Baseline LVEF ≥ 55%, as measured with the standard procedure; * Consent of women of childbearing potential to use highly effective methods of contraception, starting from the signing of the informed consent form, throughout the study and for 6 months after receiving the last dose of the product. Exclusion Criteria: * Stage IV (metastatic) breast cancer; * A history of any systemic therapy for breast cancer; * Concomitant diseases and/or conditions that significantly increase the risk of adverse events during the study; * Pregnancy or breastfeeding, as well as pregnancy planning throughout the study and for 6 months after receiving the last dose of the product; * Hypersensitivity or allergy to any of the components of BCD-178, Perjeta, trastuzumab, carboplatin, and docetaxel.
Where this trial is running
Moscow and 2 other locations
- The Loginov Moscow Clinical Scientific Center MHD — Moscow, Russian Federation (RECRUITING)
- Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary" — Omsk, Russian Federation (RECRUITING)
- JSC "Modern Medical Technologies" — Saint Petersburg, Russian Federation (RECRUITING)
Study contacts
- Study coordinator: Vladimir Chistiakov
- Email: chistiakov@biocad.ru
- Phone: +7 (812) 380 49 34
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Breast Cancer