Trastuzumab + Pertuzumab + Docetaxel + Carboplatin for Breast Cancer

Not yet recruiting at 6 trial locations

Overseen By Mridula A George

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Rutgers, The State University of New Jersey

Disqualifiers: Metastatic disease, Bilateral breast cancer, Cardiac 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)

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

Compensation: Varies

Number of Visits: Unknown

Duration: 18-24 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a combination of drugs for effectiveness in people with HER2-positive breast cancer. Researchers aim to determine if these drugs shrink tumors and improve long-term cancer-free survival. They also seek to assess whether special tests can predict treatment effectiveness. Suitable participants have HER2-positive breast cancer with tumors larger than 2 cm or cancer in lymph nodes. As a Phase 2 trial, this research focuses on evaluating the treatment's effectiveness in an initial, smaller group.

Do I have to stop taking my current medications for this trial?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.

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

Research has shown that the combination of trastuzumab, pertuzumab, docetaxel, and carboplatin is generally well-tolerated by patients. A major study found that adding pertuzumab to this mix improved the chances of patients being disease-free and achieving a complete response in those with HER2-positive breast cancer. These results are promising for those considering this treatment.

Regarding safety, the treatment is usually manageable but can cause some side effects. Common side effects include fatigue, nausea, and hair loss. Serious side effects, such as heart problems, are rare but possible. This combination has been used for breast cancer for some time and has a history of safety and effectiveness.

For those considering joining a trial with this treatment, discussing any concerns with the trial team is important. They can provide more detailed information on what to expect. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments for breast cancer?

Researchers are excited about this treatment combination for breast cancer because it targets the disease in a multi-faceted way. Unlike standard treatments that often rely solely on chemotherapy, this approach combines trastuzumab and pertuzumab, which specifically target the HER2 protein, a common driver of aggressive breast cancer. This dual targeting can potentially enhance the effectiveness of the treatment, offering a tailored approach that might lead to better outcomes for patients. Additionally, the treatment also incorporates carboplatin and docetaxel, which are well-established chemotherapy agents, aiming to maximize cancer cell eradication. This comprehensive strategy could provide a more powerful attack against cancer cells, particularly for those who test positive for the HARPS marker, offering hope for improved treatment responses.

What evidence suggests that this trial's treatments could be effective for HER2 positive breast cancer?

This trial will evaluate the effectiveness of combining trastuzumab and pertuzumab for treating HER2-positive breast cancer. Studies have shown that this combination is effective for this condition. Research indicates that it can significantly reduce the risk of cancer progression or death. In one long-term study, adding pertuzumab to trastuzumab and chemotherapy lowered the risk of death by 17%. This demonstrates a strong benefit for individuals with this type of breast cancer. These findings support the treatment's effectiveness in improving survival rates. ^{3 4 6 7 8}

Are You a Good Fit for This Trial?

The EUREKA Study is for individuals with early-stage HER2-positive breast cancer. Participants will be tested using the HARPS biomarker assay to determine eligibility. Key criteria include a confirmed diagnosis of HER2-positive breast cancer and suitability for neoadjuvant therapy.

Inclusion Criteria

I am willing and able to follow the study's schedule and treatments.

Patients must have ctDNA collection prior to treatment on trial

Patient must be able to do breast MRI as determined by the study

Exclusion Criteria

My cancer has spread to other parts of my body.

I have cancer in both breasts.

I've had treatments like chemotherapy for breast cancer but may start one cycle of HP before the study.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Patients with HARPS-positive HER2-positive breast cancer will be treated with dual HER2-targeted therapy (trastuzumab and pertuzumab) for 3 cycles. If there is treatment response, patients will continue with 6 cycles of trastuzumab and pertuzumab. If no response, additional chemotherapy will be added.

18-24 weeks

Surgery

Patients will proceed with breast surgery after completion of neoadjuvant therapy.

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment, including monitoring for ctDNA clearance and quality of life measures.

up to 36 months

What Are the Treatments Tested in This Trial?

Interventions

• Carboplatin
• Docetaxel
• Pertuzumab
• Trastuzumab

Trial Overview

This study tests how well patients respond to an adaptive combination of Trastuzumab, Docetaxel, Pertuzumab, and Carboplatin before surgery. It aims to optimize treatment based on individual tumor biology as indicated by the HARPS test and track long-term survival without disease recurrence.

How Is the Trial Designed?

Group I: HARPS POSITIVE COHORT Experimental Treatment 4 Interventions

Arm A HARPS POSITIVE COHORT PART A: Patients with HARPS positive HER2 positive breast cancer will be treated with trastuzumab and pertuzumab for three cycles. PART B: Patients who have adequate treatment response after 3 cycles, continue trastuzumab and pertuzumab every 3 weeks for a minimum of 8 cycles in the neoadjuvant setting ARM B: HARPS-NEGATIVE COHORT Patients with HARPS negative tumors must have baseline detectable ctDNA. If patients do not have detectable ctDNA, they will be taken off study. These patients will be replaced.

Who Is Running the Clinical Trial?

Rutgers, The State University of New Jersey

Lead Sponsor

Trials

471

Recruited

81,700+

Citations

1.

nejm.org

nejm.org/doi/full/10.1056/NEJMoa2508668

Trastuzumab Deruxtecan plus Pertuzumab for HER2 ...

Trastuzumab deruxtecan plus pertuzumab led to a significantly lower risk of progression or death than THP when used as first-line treatment for ...

2.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41160818/

Trastuzumab Deruxtecan plus Pertuzumab for HER2- ...

Conclusions: Trastuzumab deruxtecan plus pertuzumab led to a significantly lower risk of progression or death than THP when used as first-line ...

3.

roche.com

roche.com/media/releases/med-cor-2025-05-13

Ten-year APHINITY data show Roche's Perjeta-based ...

After ten years, the risk of death was reduced by 17% for people treated with Perjeta® (pertuzumab), Herceptin® (trastuzumab) and chemotherapy (the Perjeta- ...

4.

onclive.com

onclive.com/view/adjuvant-pertuzumab-plus-trastuzumab-and-chemotherapy-leads-to-os-benefit-in-early-stage-her2-breast-cancer

Adjuvant Pertuzumab Plus Trastuzumab and ... - OncLive

The APHINITY trial showed a 17% reduction in death risk with pertuzumab in early-stage HER2-positive breast cancer. The 10-year overall survival ...

5.

perjeta-hcp.com

perjeta-hcp.com/metastatic/efficacy.html

PERJETA® (pertuzumab) for HER2+ Metastatic Outcomes

Learn about the outcomes in HER2+ metastatic breast cancer with PERJETA-based therapy. See Full Safety including Boxed Warnings for more information.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10687954/

Efficacy and Safety of Dual Anti-HER2 Blockade and ... - PMC

Introduction: This study aimed to compare the efficacy and safety of docetaxel + trastuzumab + pertuzumab and docetaxel + carboplatin + ...

7.

ascopubs.org

ascopubs.org/doi/10.1200/GO-25-00273

Pertuzumab/Docetaxel/Carboplatin/Trastuzumab Regimen ...

The addition of pertuzumab to trastuzumab and chemotherapy has improved disease-free survival (DFS) and pathologic complete response (pCR) rates ...

8.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5584549/

Pertuzumab, Trastuzumab, and Docetaxel in HER2 ... - PMC

One retrospective study has shown better outcomes with trastuzumab in patients with metastatic breast cancer who had received no previous adjuvant or ...