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AzTrials

Early Breast CancerPhase 3EGC102NCT06884254

Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer.

A Phase 3 study testing EG1206A and Perjeta in people with Early Breast Cancer, run by EirGenix, Inc. at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

The purpose of this research study is to compare the efficacy and safety of EG1206A with Perjeta in combination with trastuzumab and chemotherapy as neoadjuvant treatment for 18 weeks, followed by surgery and subsequent EG1206A or Perjeta in combination with trastuzumab, as adjuvant treatment for 36 weeks. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Early Breast Cancer
What is being tested?
EG1206A and Perjeta
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
1 siteUnited States
Study dates
May 2025to Dec 2027
Phase
Phase 3
Are there results?
None posted in the registry

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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are eligible to be included in the study only if all of the following criteria apply:
  • Provide signed and dated written informed consent before any study related procedures are performed. The informed consent will cover both parts of the study (neoadjuvant part and adjuvant part).
  • Female and male patients ≥ 18 and ≤ 70 years of age.
  • Histologically-confirmed invasive carcinoma of the breast.
  • Early stage (T2-3, N0-1, M0), locally advanced stage (T2-3, N2-3, M0 or T4a-c, any N, M0), or inflammatory (T4d, any N, M0) breast cancer planned for surgical resection (mastectomy or lumpectomy of the breast, and resection of sentinel or axillary lymph nodes).
  • Unilateral, measurable tumor of the breast > 2 cm in diameter (by ultrasound and/or mammography).
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  • HER2-positive tumor status (according to American Society of Clinical Oncology/College of American Pathologists [ASCO/CAP] guidelines [2018, 2023]), as confirmed by central laboratory.
  • Estrogen receptor and progesterone receptor-negative tumor (according to ASCO/CAP guidelines [2020]), as confirmed by central laboratory.
  • Eastern Cooperative Oncology Group (ECOG) score of 0 or 1.
  • Baseline left ventricular ejection fraction (LVEF) ≥ 55%, measured by echocardiography or MUGA (multigated acquisition scan).
  • Adequate bone marrow function, defined as neutrophil count of ≥ 1,500/µL, hemoglobin ≥ 9 g/dL, and platelet count of ≥ 100,000/µL.
  • Adequate hepatic and renal function, defined as total bilirubin ≤ 1.5 × upper limit of normal (ULN) (or ≤ 3 × ULN and direct bilirubin within normal limits in patients with well documented Gilbert's syndrome), alanine aminotransferase (ALT) ≤ 3 × ULN, aspartate aminotransferase (AST) ≤ 3 × ULN, creatinine clearance ≥ 30 mL/min (according to Cockcroft and Gault equation).
  • International normalized ratio ≤ 1.5 × ULN (2 to 3 × ULN if on anticoagulants with vitamin K antagonists) or prothrombin time ≤ 1.5 × ULN; activated partial thromboplastin time ≤ 1.5 × ULN.
  • For women of childbearing potential (WOCBP): WOCBP must have a negative serum pregnancy test at Screening and must use adequate birth control. Adequate birth control is defined as agreement to consistently practice an effective and accepted method of contraception throughout the duration of the study and for 7 months after the End of Treatment (EOT) Visit. These methods include hormonal contraceptives, intrauterine device, or double barrier contraception (i.e., condom + diaphragm) or a male partner with documented vasectomy. Non-childbearing potential is defined as post-menopausal for at least 1 year or surgical sterilization or hysterectomy at least 3 months before study start. Women will be considered post-menopausal if they have been amenorrheic for 12 months without an alternative medical cause.
  • For men: Men must agree to use reliable contraceptive measures throughout the duration of the study and for 7 months after the EOT Visit. These methods include documented vasectomy, double-barrier contraception (i.e., condom and diaphragm), or true sexual abstinence (when this is in line with the preferred and usual lifestyle of the patient).
  • Inclusion Criteria (after surgery for the adjuvant part of the study)
  • Patients with complete pathological remission.
  • Patients with residual disease that cannot receive further treatment with trastuzumab emtansine (in case of contraindication to trastuzumab emtansine, recommendations from local guidelines, or at the discretion of the Investigator).

Who cannot join

  • Stage IV (metastatic) breast cancer, bilateral breast cancer.
  • Pregnancy or lactation or considering becoming pregnant.
  • Previous treatment (chemotherapy, biologic therapy, radiation, or surgery) for invasive malignant disease or other concomitant malignancy, other than basal cell carcinoma of the skin. Previous treatment for carcinoma in situ of the cervix is allowed.
  • Previous treatment with Perjeta.
  • Active hepatitis B or hepatitis C infection, or infection with the human immunodeficiency virus (HIV) as shown by a positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV.
  • History of or existing congestive heart failure (CHF) New York Heart Association class II or higher; angina pectoris or arrhythmia requiring medication; poorly controlled hypertension; history of myocardial infarction or cardiac failure; clinically significant cardiac valvular disease; hemodynamic effective pericardial effusion; other cardiomyopathies.
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  • Any investigational treatment less than 30 days prior to study entry, or within a time interval less than at least 5 half-lives of the investigational medicinal product (IMP: EG1206A or Perjeta), whichever is longer.
  • Hypersensitivity to the IMP (EG1206A or Perjeta), trastuzumab or trastuzumab biosimilar, carboplatin (or other platin compounds), and docetaxel, or to any of their excipients.
  • Vaccination with live attenuated vaccines during the study.
  • History of, or known current problems with, drug or alcohol abuse.
  • Other serious illness, previous surgery (other than for invasive malignant disease), medical disorder or condition that, in the opinion of the Investigator, would make the patient unsuitable for participation in the study.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Methodist Health System Clinical Research Institute

    Dallas, Texas, 75023

Other trials in United States

About this study

Official title: A Phase 3, Randomized, Multicenter, Parallel-arm, Double-blind Study to Compare Efficacy and Safety of EG1206A (EirGenix' Pertuzumab) and Perjeta® (Pertuzumab) Sourced From EU as Neoadjuvant Treatment in Combination With Trastuzumab and Chemotherapy in Patients With HER2-positive Hormone Receptor-negative Early Breast Cancer

The purpose of this research study is to compare the efficacy and safety of EG1206A with Perjeta in combination with trastuzumab and chemotherapy as neoadjuvant treatment for 18 weeks, followed by surgery and subsequent EG1206A or Perjeta in combination with trastuzumab, as adjuvant treatment for 36 weeks.

Being tested
EG1206A, 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.

  • EG1206ADrug

    EG1206A 420mg is ongoing to be administered after 840mg loading dose.

  • PerjetaDrug

    Perjeta 420mg is ongoing to be administered after 840mg loading dose.

Study groups in NCT06884254
Study groupRoleWhat they receive
EG1206AExperimentalDuring the neoadjuvant treatment period, patients will receive 6 cycles with EG1206A, trastuzumab, and chemotherapy (docetaxel and carboplatin), followed by surgery. If criteria to remain on study are still fulfilled, patients will continue treatment in the adjuvant setting, starting 2 to 6 weeks after surgery. Patients will receive 12 cycles with EG1206A and trastuzumab (as originally randomized in the neoadjuvant part) to complete 1 year of HER2-targeted therapy.
Receives: Drug: EG1206A
PerjetaActive comparatorDuring the neoadjuvant treatment period, patients will receive 6 cycles with Perjeta, trastuzumab, and chemotherapy (docetaxel and carboplatin), followed by surgery. If criteria to remain on study are still fulfilled, patients will continue treatment in the adjuvant setting, starting 2 to 6 weeks after surgery. Patients will receive 12 cycles with Perjeta and trastuzumab (as originally randomized in the neoadjuvant part) to complete 1 year of HER2-targeted therapy.
Receives: Drug: Perjeta

What is being measured

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

  1. Determination of pathologic complete response (pCR) at time of surgery

    • pCR at time of surgery, where pCR is defined as the absence of residual invasive cancer of the complete resected breast specimen (regardless of ductal carcinoma in situ [DCIS]) and all sampled sentinel and/or axillary lymph nodes (ypT0/is ypN0), as assessed by central laboratory.

    Measured: At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy)

Timeline

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

  1. First posted19 Mar 2025
  2. Study startMay 2025 (estimated)
  3. Primary completionNov 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Why it stopped: Following SA from both the US FDA and the EMA, EirGenix, Inc. has decided to streamline the clinical-development program for EG1206A (biosimilar to Perjeta). EirGenix has concluded that the continuation of the study in no longer necessary.

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
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06884254
Sponsor's protocol ID
EGC102
Other IDs
2024-518619-21-00
Acronym
EGC102
Status last verified
Oct 2025
First submitted
18 Mar 2025
Last updated
14 Oct 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing EG1206A and Perjeta in people with Early Breast Cancer, run by EirGenix, Inc. at 1 site in United States.

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 18 inclusion and 11 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: withdrawn, as of the sponsor's last update on 14 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Determination of pathologic complete response (pCR) at time of surgery (time frame: At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy)). 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 NCT06884254.

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 14 Oct 2025.

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