EG1206A vs Perjeta for Breast Cancer

(EGC102 Trial)

Overseen By Jens Henneberg

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: EirGenix, Inc.

Stay on Your Current Meds

No Placebo Group

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for men and women aged 18-70 with early or locally advanced stage HER2-positive, hormone receptor-negative breast cancer. Participants must have a measurable tumor over 2 cm, be in good physical condition (ECOG score of 0 or 1), and have normal heart function (LVEF ≥ 55%). They need to consent to both the neoadjuvant (before surgery) and adjuvant (after surgery) parts of the study.

Inclusion Criteria

I meet the requirements to be considered for the study before being assigned to a group.

I have signed and understand the consent form for all parts of the study.

I am between 18 and 70 years old.

Treatment Details

Interventions

• EG1206A (Monoclonal Antibodies)
• Perjeta (Monoclonal Antibodies)

Trial Overview The study tests EG1206A's effectiveness compared to Perjeta, alongside trastuzumab and chemotherapy. It involves an initial treatment phase before surgery for 18 weeks, followed by continued therapy after surgery for another 36 weeks to assess long-term safety and efficacy.

Participant Groups

Group I: EG1206A Experimental Treatment 1 Intervention

During 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.

Group II: Perjeta Active Control 1 Intervention

During 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.

Who Is Running the Clinical Trial?

EirGenix, Inc.

Lead Sponsor

Trials

4

Recruited

1,400+