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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the effectiveness of a new treatment, EG1206A (an experimental treatment), compared to Perjeta when combined with other standard breast cancer treatments. Researchers seek to determine which combination is more effective and safe for individuals with early-stage or locally advanced HER2-positive breast cancer. Participants will receive treatment before surgery and continue with additional therapy afterward. This trial may suit those with HER2-positive breast cancer that hasn't spread and who have not previously received Perjeta. As a Phase 3 trial, this study represents the final step before potential FDA approval, offering participants the opportunity to contribute to a treatment that could soon become widely available.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that EG1206A, a treatment being tested for breast cancer, has met its initial safety goals. In early studies, patients tolerated it well, and no unexpected side effects emerged. Research indicates that EG1206A works similarly to Perjeta, a treatment already approved by the FDA for HER2-positive breast cancer. This approval suggests that treatments like EG1206A can be safe for people. However, since EG1206A is still under investigation, more information is needed to confirm its long-term safety.

Perjeta, in contrast, is already approved and has been used safely with other treatments for HER2-positive breast cancer. While side effects can occur, they are generally known and manageable, making Perjeta a reliable option for patients in the trial. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for breast cancer?

Researchers are excited about EG1206A for breast cancer because it potentially offers a new approach to HER2-targeted therapy. Unlike current standard treatments like Perjeta, EG1206A combines with trastuzumab and chemotherapy to enhance the treatment's effectiveness against cancer cells. This combination could lead to improved outcomes by more effectively targeting the HER2 protein, which is overexpressed in some breast cancers. The hope is that EG1206A might offer better results, especially for patients who have limited response to existing therapies.

What evidence suggests that this trial's treatments could be effective for breast cancer?

This trial will compare EG1206A with Perjeta for treating HER2-positive breast cancer. Studies have shown that Perjeta, when combined with trastuzumab and chemotherapy, benefits patients with this type of cancer. EG1206A, which participants in this trial may receive, is similar to Perjeta and attaches to HER2 receptors in a unique way, potentially enhancing its effectiveness. Early research suggests that EG1206A can block cancer growth in two ways, which could be beneficial for this type of cancer. This research indicates that EG1206A might perform as well as Perjeta. Although direct data on EG1206A is still being collected, its promising mechanism offers potential for treating HER2-positive breast cancer. ^{1 2 6 7 8}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

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EG1206A has a unique binding mechanism for HER2 receptors which can produce a dual blockade effect. In combination with the first-generation ...