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Breast CancerPhase 3PREFERNCT05802225

Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer

A Phase 3 study testing BCD-178 and Perjeta in people with Breast Cancer, run by Biocad at 3 sites in Russia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

The goal of this study is to compare the efficacy and safety of BCD-178 and Perjeta as neoadjuvant therapy for HER2-positive breast cancer. Subjects with histologically confirmed diagnosis of HER2-positive invasive breast cancer (stage II-III, tumor size > 2 cm), with no estrogen (ER) and progesterone (PR) receptors… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
BCD-178 and Perjeta
Could I receive a placebo?
No, everyone receives an active treatment
How many people
398 participants
Where
3 sitesRussia
Study dates
30 Jan 2023to 20 Feb 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

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

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

3 sites in 1 country.

Russia3 sites

  • The Loginov Moscow Clinical Scientific Center MHD

    Moscow, 111123

  • Budgetary healthcare institution of the Omsk region "Clinical oncological dispensary"

    Omsk

  • JSC "Modern Medical Technologies"

    Saint Petersburg, Sankt-Peterburg, 190013

Other trials in Russia

About this study

Official title: A Double-Blind, Randomized Clinical Study of the Efficacy and Safety of BCD-178 and Perjeta® as Neoadjuvant Therapy of HER2-Positive Breast Cancer

The goal of this study is to compare the efficacy and safety of BCD-178 and Perjeta as neoadjuvant therapy for HER2-positive breast cancer.

Subjects with histologically confirmed diagnosis of HER2-positive invasive breast cancer (stage II-III, tumor size > 2 cm), with no estrogen (ER) and progesterone (PR) receptors will be randomized to one of two treatment groups (BCD-178 group or Perjeta group) in a 1:1 ratio.

Conditions
Breast Cancer
Being tested
BCD-178, Perjeta
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BCD-178Drug

    Also called pertuzumab

    at an initial dose of 840 mg (1 cycle), then 420 mg

  • PerjetaDrug

    Also called pertuzumab

    at an initial dose of 840 mg (1 cycle), then 420 mg

Study groups in NCT05802225
Study groupRoleWhat they receive
BCD-178 groupExperimentalNeoadjuvant therapy stage (6 cycles, 18 weeks): BCD-178, Trastuzumab, Docetaxel, Carboplatin; Surgical treatment; Adjuvant therapy stage (up to 12 months of HER2-targeted therapy in total): BCD-178, Trastuzumab
Receives: Drug: BCD-178
Perjeta GroupActive comparatorNeoadjuvant therapy stage (6 cycles, 18 weeks): Perjeta, Trastuzumab, Docetaxel, Carboplatin; Surgical treatment; Adjuvant therapy stage (up to 12 months of HER2-targeted therapy in total): BCD-178, Trastuzumab
Receives: Drug: Perjeta

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To compare the efficacy of BCD-178 and Perjeta as neoadjuvant therapy by studying the total pathological complete response (tpCR) rate

    Proportion of subjects achieving tpCR

    Measured: immediately after the surgery

Secondary outcomes (6)

  1. breast pathological complete response (bpCR) rate

    Proportion of subjects achieving bpCR;

    Measured: immediately after the surgery

  2. overall response rate (ORR)

    the ORR according to RECIST 1.1 criteria

    Measured: at Week 18

  3. breast-conserving surgery rate

    Proportion of subjects with breast-conserving surgery

    Measured: immediately after surgery

  4. safety assessment

    Proportion of subjects with adverse reactions; Proportion of subjects with CTCAE 5.0 grade 3 or higher adverse reactions; • Proportion of subjects with serious adverse reactions; • Proportion of subjects who prematurely discontinued neoadjuvant therapy due to adverse reactions

    Measured: up to 65 weeks

  5. immunogenicity assessment

    Proportion of subjects with binding and neutralizing antibodies

    Measured: pre-dose to week 52, 5 timepoints

  6. Pharmacokinetics assessment

    Cmin - minimum observed product concentration ; Ceoi - concentration at the end of each infusion

    Measured: pre-dose to week 18, 12 timepoints

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2023
  2. Study start30 Jan 2023
  3. Primary completion6 Jun 2025
  4. Study completion20 Feb 2026 (estimated)

Resources

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
398 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05802225
Sponsor's protocol ID
BCD-178-2
Acronym
PREFER
Status last verified
Jul 2025
First submitted
13 Feb 2023
Last updated
20 Jul 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing BCD-178 and Perjeta in people with Breast Cancer, run by Biocad at 3 sites in Russia.

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 8 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 20 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Russia. 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?

This study is still under way. Results are not available in the source record yet.

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?

To compare the efficacy of BCD-178 and Perjeta as neoadjuvant therapy by studying the total pathological complete response (tpCR) rate (time frame: immediately after the surgery). 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 NCT05802225.

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 20 Jul 2025.

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