What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving chemotherapy and HER2 inhibition such as the combination of Paclitaxel, Trastuzumab, and Pertuzumab, have several known side effects. Paclitaxel is associated with neuropathy, myalgias, weakness, and a higher risk of febrile neutropenia. Trastuzumab can cause chills, fever, nausea, vomiting, weakness, headache, and more seriously, cardiac dysfunction. Pertuzumab, when combined with Trastuzumab, can enhance these effects and may also lead to diarrhea, rash, and fatigue. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

The FDA has approved several treatments for HER2-positive breast cancer that involve combinations of chemotherapy and HER2 inhibitors. Notably, the combination of Paclitaxel (Taxol), Trastuzumab (Herceptin), and Pertuzumab (Perjeta) is a well-studied regimen. Trastuzumab and Pertuzumab are monoclonal antibodies that target the HER2 receptor, and their combination with chemotherapy agents like Paclitaxel has been shown to improve outcomes in patients with HER2-positive breast cancer. Other related FDA-approved treatments include Trastuzumab emtansine (T-DM1) and combinations involving Lapatinib, another HER2 inhibitor, often used with Capecitabine for patients who have progressed on Trastuzumab-based therapies.

What other types of research exist?

Promising novel alternatives for HER2-positive breast cancer treatment include dual HER2-targeted therapies such as Trastuzumab combined with Lapatinib or Pertuzumab, as well as newer agents like Trastuzumab Deruxtecan. These alternatives have shown efficacy in clinical trials and may offer additional options for patients considering treatment in 2024.

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Microtubule Inhibitor

Paclitaxel + Trastuzumab + Pertuzumab for Breast Cancer

Phase 1

Waitlist Available

Led By Adrienne G Waks, MD

Research Sponsored by Dana-Farber Cancer Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

ECOG PS 0 or 1

Patients must have Stage II or III histologically confirmed invasive carcinoma of the breast with a minimum tumor size of 1.5 cm

Must not have

Any prior treatment for the current breast cancer

Significant symptoms (Grade ≥ 2) from peripheral neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2.5 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of three drugs to treat breast cancer. It aims to see if patients' responses can help decide their future treatment. The drugs work by stopping cancer growth and boosting the immune system to fight the cancer.

Who is the study for?

This trial is for adults with Stage II or III HER2-positive invasive breast cancer, who can provide consent and tissue samples. They must have a tumor size of at least 1.5 cm, no serious heart conditions, an ECOG performance status of 0 or 1 (fully active or restricted in physically strenuous activity but ambulatory), and acceptable blood test results. Pregnant/nursing individuals, those with unresolved infections or significant cardiovascular disease are excluded.

What is being tested?

The DAPHNe study tests if patients/doctors will choose post-surgery treatment based on pre-surgery response to a drug combo: Paclitaxel (Taxol), Trastuzumab (Herceptin), Pertuzumab (Perjeta). It also examines the collected blood/tissue from participants receiving these drugs for treating HER2-positive breast cancer.

What are the potential side effects?

Possible side effects include allergic reactions to the drugs, potential damage to nerves causing numbness/tingling/pain (peripheral neuropathy), lowered white blood cell count increasing infection risk, heart problems due to Herceptin/Pertuzumab affecting cardiac function.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am fully active or restricted in physically strenuous activity but can do light work.

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My breast cancer is Stage II or III and my tumor is at least 1.5 cm big.

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My tumor is HER-2 positive according to tests.

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I can safely receive radiation therapy for my breast cancer.

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I have had DCIS in the same breast before.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have received treatment for my current breast cancer.

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I experience significant discomfort or pain from nerve damage.

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I am currently fighting an infection that hasn't healed.

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I have high blood pressure or heart problems that are not well-managed.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2.5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2.5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2.5 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Adjuvant chemotherapy Received

Secondary study objectives

Event-Free Survival (EFS)

One Year of Trastuzumab and Pertuzumab

Overall survival (OS)

+6 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729

59%

Leukopenia

56%

Neutropenia

34%

Hypoaesthesia

31%

Agranulocytosis

22%

Alopecia

22%

Asthenia

19%

Pyrexia

16%

Nail disorder

16%

Oedema peripheral

16%

Diarrhoea

16%

Hypophagia

13%

Alanine aminotransferase increased

13%

Neurotoxicity

13%

Cough

13%

Vomting

Musculoskeletal pain

Aspartate aminotransferase increased

Headache

Chest discomfort

Rash

Pigmentation disorder

Nausea

Bone marrow failure

Anaemia

Transaminases increased

Insomnia

Constipation

Mouth ulceration

Nasopharyngitis

Paronychia

Flushing

Face oedema

Thrombocytopenia

Infection

Upper respiratory tract infection

Completed suicide

Cataract

100%

80%

60%

40%

20%

Study treatment Arm

Trastuzumab

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Paclitaxel+Trastuzumab+PertuzumabExperimental Treatment3 Interventions

Paclitaxel is administered intravenously on days 1, 8, and 15 of each 21-day cycle Trastuzumab is administered intravenously on day 1 of each 21-day cycle Pertuzumab is administered intravenously on Day 1 of each 21-day cycle

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Paclitaxel

2011

Completed Phase 4

~5810

Trastuzumab

2014

Completed Phase 4

~5190

Pertuzumab

2014

Completed Phase 3

~7500

0 / 9Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The combination of Paclitaxel, Trastuzumab, and Pertuzumab is a common treatment for HER2-positive breast cancer. Paclitaxel, a chemotherapy agent, disrupts cell division, causing cancer cell death. Trastuzumab and Pertuzumab are monoclonal antibodies that target the HER2 receptor, which is overexpressed in some breast cancers. By blocking HER2 signaling pathways, these drugs inhibit tumor growth and survival. This targeted approach is crucial for breast cancer patients as it enhances treatment efficacy and can lead to improved clinical outcomes.

Receptor tyrosine kinase inhibitors for the treatment of osteosarcoma and Ewing sarcoma.Compound-therapy based on cancer-immunity cycle: promising prospects for antitumor regimens.Comparative Efficacy and Tolerability of Neoadjuvant Immunotherapy Regimens for Patients with HER2-Positive Breast Cancer: A Network Meta-Analysis.