EG1206A vs Perjeta for Breast Cancer

(EGC102 Trial)

Overseen By Jens Henneberg

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: EirGenix, Inc.

Must not be taking: Perjeta, Antivirals, Antiretrovirals, others

Disqualifiers: Metastatic cancer, Pregnancy, Heart disease, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

380 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are on any investigational treatments, you must stop them at least 30 days before entering the study.

What data supports the effectiveness of the drug Perjeta for breast cancer?

Perjeta, a drug used for HER2-positive breast cancer, has been shown to improve patient outcomes when combined with chemotherapy and trastuzumab, especially in early-stage and metastatic cases. It is approved for use in these settings, indicating its effectiveness in treating this type of breast cancer. ^{1 2 3 4 5}

Is Perjeta safe for human use?

Perjeta (pertuzumab) has been studied for safety in various trials, including one with healthy volunteers, showing similar safety profiles to a biosimilar drug, SHR-1309. Common side effects include hair loss, nausea, diarrhea, anemia (low red blood cell count), and weakness, but overall, it is considered safe for use in humans. ^{1 2 6 7 8}

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.

My breast cancer has been confirmed by a biopsy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Neoadjuvant Treatment

Participants receive 6 cycles of EG1206A or Perjeta in combination with trastuzumab and chemotherapy (docetaxel and carboplatin) for 18 weeks

18 weeks

Surgery

Participants undergo surgery to assess pathologic complete response (pCR)

3-6 weeks after completion of neoadjuvant chemotherapy

Adjuvant Treatment

Participants receive 12 cycles of EG1206A or Perjeta in combination with trastuzumab to complete 1 year of HER2-targeted therapy

36 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• EG1206A
• Perjeta

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+

Findings from Research

In a study of 266 patients with HER2-positive metastatic breast cancer, the majority received a treatment regimen of trastuzumab, pertuzumab, and a taxane, which aligns with the standard first-line therapy.

The median progression-free survival (PFS) for patients was 16.9 months, and the safety profile, including common side effects like fatigue and diarrhea, was consistent with findings from the pivotal CLEOPATRA trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

HER2-Positive Metastatic Breast Cancer Patients Receiving Pertuzumab in a Community Oncology Practice Setting: Treatment Patterns and Outcomes. Robert, NJ., Goertz, HP., Chopra, P., et al.[2020]

Pertuzumab, a new monoclonal antibody targeting HER2, has shown improved patient outcomes in clinical trials for early-stage and metastatic HER2-positive breast cancer, especially when used in combination with chemotherapy and trastuzumab.

The review highlights that while trastuzumab has improved survival for HER2-positive breast cancer, there is still a need for better treatment options, which pertuzumab aims to address, particularly for patients who continue to relapse.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pertuzumab in human epidermal growth-factor receptor 2-positive breast cancer: clinical and economic considerations. Lamond, NW., Younis, T.[2021]

The EMA has approved the use of adjuvant pertuzumab for treating HER2-positive early-stage breast cancer based on the results of the APHINITY trial, highlighting its efficacy as an add-on therapy.

Physicians need to contextualize the APHINITY study data with other treatment strategies and identify high-risk patients, particularly those with hormone receptor-negative breast cancer, to optimize treatment decisions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Contextualizing pertuzumab approval in the treatment of HER2-positive breast cancer patients. Cortés, J., Ciruelos, E., Pérez-García, J., et al.[2020]

The FDA approved Phesgo, a subcutaneous injection combining pertuzumab, trastuzumab, and hyaluronidase-zzxf, for treating HER2-positive early-stage and metastatic breast cancer, based on the FeDeriCa trial which showed that the subcutaneous formulation is pharmacokinetically comparable to the intravenous versions.

The study demonstrated that the subcutaneous treatment had similar efficacy to intravenous treatments, with common side effects including alopecia, nausea, and diarrhea, supporting its use across all approved indications for breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer. Gao, JJ., Osgood, CL., Gong, Y., et al.[2022]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

HER2-Positive Metastatic Breast Cancer Patients Receiving Pertuzumab in a Community Oncology Practice Setting: Treatment Patterns and Outcomes. [2020]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Pertuzumab in human epidermal growth-factor receptor 2-positive breast cancer: clinical and economic considerations. [2021]

3. England pubmed.ncbi.nlm.nih.gov

A randomized, double-blind, single-dose, single-center, parallel phase I clinical study comparing the pharmacokinetics, immunogenicity, safety, and tolerance of pertuzumab injection and Perjeta® in healthy Chinese male subjects. [2022]

4. England pubmed.ncbi.nlm.nih.gov

Impact of Dose Delays and Alternative Dosing Regimens on Pertuzumab Pharmacokinetics. [2023]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Contextualizing pertuzumab approval in the treatment of HER2-positive breast cancer patients. [2020]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Pharmacokinetics, Immunogenicity and Safety Study for SHR-1309 Injection and Perjeta® in Healthy Chinese Male Volunteers. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

FDA Approval Summary: Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf Injection for Subcutaneous Use in Patients with HER2-positive Breast Cancer. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Efficacy and safety of treatment with or without pertuzumab for HER2-positive breast cancer: A meta-analysis. [2023]