What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those targeting the HER2 receptor like Trastuzumab, are associated with several side effects. Trastuzumab can cause cardiotoxicity, including heart failure, and requires regular cardiac monitoring. Other side effects include infusion-related reactions, such as fever and chills, and gastrointestinal symptoms like nausea and diarrhea. Endocrine therapies, such as tamoxifen and aromatase inhibitors, are also widely used. Tamoxifen can cause hot flashes, increased risk of thromboembolic events, and endometrial cancer, while aromatase inhibitors are associated with bone density loss, fractures, and cardiovascular risks.

What prior FDA approvals exist?

Trastuzumab, a monoclonal antibody targeting the HER2 receptor, has been a cornerstone in the treatment of HER2-positive breast cancer. The FDA has approved several HER2-targeted therapies, including trastuzumab emtansine (T-DM1) and fam-trastuzumab deruxtecan, which are antibody-drug conjugates used in various settings of breast cancer treatment. These therapies have shown significant efficacy in reducing recurrence and improving survival rates. Additionally, pertuzumab, another HER2-targeted monoclonal antibody, is often used in combination with trastuzumab and chemotherapy to enhance treatment outcomes. These approvals highlight the critical role of HER2-targeted therapies in managing HER2-positive breast cancer.

What other types of research exist?

Promising novel alternatives to Trastuzumab for HER2-positive breast cancer patients include Trastuzumab Deruxtecan (T-DXd) and Trastuzumab Emtansine (T-DM1). Trastuzumab Deruxtecan has shown significant antitumor activity and safety in patients with previously treated HER2-positive breast cancer, including those with brain metastases. Trastuzumab Emtansine has also demonstrated efficacy in patients with HER2-positive metastatic breast cancer, particularly in those with central nervous system metastases.

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Shorter HER2-targeted Therapy for Breast Cancer

Phase 4

Recruiting

Led By Sharon McGee, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

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

Must have

Treated with neoadjuvant chemotherapy and HER2 targeted therapy preoperatively with a pathological complete response (pCR) defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled regional lymph nodes following completion of neoadjuvant systemic therapy at surgery. Must have received less than 6 months of HER2 targeted therapy

Early-stage (I-III, i.e. non-metastatic) as per AJCC 8th edition, ER/PR positive or negative, HER2-positive as per 2018 American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 (HER2) testing in breast cancer guidelines

Must not have

Residual invasive disease following neoadjuvant therapy, or metastatic disease

Contraindication to further HER2-targeted therapy following completion of neoadjuvant treatment

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 years from study enrolment

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

No Placebo-Only Group

Summary

This trial tests if a shorter treatment period is effective for early-stage, HER2-positive breast cancer patients who have responded well to initial treatment. The aim is to reduce side effects and costs while maintaining treatment effectiveness. For many years, a longer treatment period has been the standard for these patients.

Who is the study for?

This trial is for people with early-stage HER2-positive breast cancer who've had a complete response to initial chemo and HER2 therapy. They should not have any remaining invasive cancer after pre-surgery treatment, be able to consent in English or French, and haven't yet received 6 months of HER2 therapy.

What is being tested?

The study tests if 6 months of HER2-targeted therapy (Trastuzumab) is effective for patients who responded well to initial treatments. It's a single-arm, multicentre trial focused on those with non-metastatic breast cancer seeking less intensive post-surgery treatment.

What are the potential side effects?

Trastuzumab can cause heart problems like heart failure and may require regular hospital visits for administration. The goal is to see if reduced treatment duration lowers these risks while maintaining effectiveness.

Eligibility Criteria

Inclusion Criteria

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

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I had successful breast cancer treatment with no cancer found after surgery and took HER2 therapy for less than 6 months.

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My breast cancer is in stages I-III and may be ER/PR positive or negative, but is HER2 positive.

Exclusion Criteria

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

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My cancer is still present after initial treatment or has spread.

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I cannot receive more HER2-targeted therapy after my initial treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 years from study enrolment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 years from study enrolment

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

Treatment Details

Study Objectives

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

Primary study objectives

Enrolment of at least 50 participants across all sites within 9 months of the fourth site accruing its first participant

Medical oncologist active participation

Multiple site activation

Secondary study objectives

Cardiac events

Disease free survival

Health-related quality of life

+3 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

Headache

Aspartate aminotransferase increased

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

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: De-escalated HER2 targeted treatmentExperimental Treatment1 Intervention

Patients with early-stage HER2-positive breast cancer who demonstrate a pathological complete response at time of surgery.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Trastuzumab

2014

Completed Phase 4

~5190

0 / 4Eligibility 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

Trastuzumab is a monoclonal antibody that targets the HER2 receptor, a protein overexpressed in some breast cancer cells, leading to uncontrolled growth. By binding to the HER2 receptor, Trastuzumab inhibits cell proliferation and promotes immune-mediated destruction of the cancer cells. This targeted approach is crucial for patients with HER2-positive breast cancer as it significantly reduces the risk of recurrence and improves survival rates. Targeted therapies like Trastuzumab are essential because they offer more effective treatment with potentially fewer side effects compared to traditional chemotherapy, thereby improving the quality of life for breast cancer patients.