Educational Intervention for Breast Cancer

Overseen By Nadia Chowdhury

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must be taking: HER2-targeted ADCs

Disqualifiers: Noncompliance, Non-ambulatory, Cognitive impairment, others

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

Compensation: Varies

Number of Visits: 3

30 Participants Needed

Trial Summary

Do I need to stop my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It focuses on educational interventions and does not mention medication changes.

What data supports the effectiveness of the educational intervention for breast cancer treatment?

The CARIATIDE study showed that educational materials can improve treatment compliance in women with early-stage breast cancer, suggesting that education can play a role in enhancing the effectiveness of breast cancer treatments. ^{1 2 3 4 5}

Is the Educational Intervention for Breast Cancer safe for humans?

HER2-targeted antibody-drug conjugates, which are similar to the Educational Intervention, have been generally well tolerated in humans, but they can cause side effects like nausea, vomiting, and more serious issues like lung problems and infections. It's important to monitor these side effects closely during treatment. ^{6 7 8 9 10}

How is the HER2 targeted antibody drug conjugate different from other breast cancer treatments?

HER2 targeted antibody drug conjugates (ADCs) are unique because they combine a monoclonal antibody, which specifically targets cancer cells, with a powerful chemotherapy drug, allowing for direct delivery of the drug to the cancer cells. This targeted approach can be effective even in cases with low HER2 expression, offering new treatment possibilities for patients who previously had limited options. ^{6 11 12 13 14}

What is the purpose of this trial?

A study uniquely focused on system-based practice change, measuring the impact of educational interventions on both patients and clinicians for the recognition and management of treatment-related adverse effects for HER2+/HER2 low breast cancer patients on or about to start on HER2 targeted antibody drug conjugates (fam-trastuzumab deruxtecan-nxki or ado-trastuzumab emtansine) and shared decision-making methodologies to improve adverse event (AE) management and patient-clinician communications.

Research Team

Nancy Chan, MD

Principal Investigator

NYU Langone Health

Eligibility Criteria

This trial is for breast cancer patients who are currently on or about to begin treatment with HER2 targeted drugs (fam-trastuzumab deruxtecan-nxki or ado-trastuzumab emtansine). It aims to improve the management of treatment-related side effects and patient-clinician communication.

Inclusion Criteria

I am a healthcare professional working with HER2-positive or low breast cancer patients.

Patients (PATIENT participant group) must be able to sign informed consent and be willing to participate in and comply with protocol requirements including visits, entry of survey information, access training, interviews, and focus group (all virtual)

Patients (PATIENT participant group) must be able to read, speak, and understand English

Exclusion Criteria

Pregnant patients are excluded from participation

I cannot walk or have serious mental health or cognitive issues.

Patients (PATIENT participant group) without internet and computer access are excluded

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Educational Intervention

Participants receive educational interventions including Shared Decision Making training, simulation case role play, and HER2-targeted ADC adverse effects management training

6 months

Multiple sessions (in-person and virtual)

Follow-up

Participants are monitored for safety and effectiveness after educational interventions

6 months

Follow-up assessments at Month 3 and Month 6

Treatment Details

Interventions

• Educational Intervention
• HER2 targeted antibody drug conjugates

Trial Overview The study tests an educational intervention designed to help both patients and clinicians better recognize and manage adverse effects from specific breast cancer treatments. The focus is on improving system-based practices and shared decision-making.

Participant Groups

Group I: Clinicians in the Oncology Breast Department Experimental Treatment 1 Intervention

Participants will receive the following educational interventions: 1. Shared Decision Making (SDM) training video 2. Simulation case role play (patient-clinician interactions) training video 3. HER2-targeted ADC adverse effects and their management training video

Group II: Adult Patients with HER2+/HER2 Low Breast Cancer Experimental Treatment 1 Intervention

Participants will receive the following educational interventions: 1. Shared Decision Making (SDM) training video 2. Simulation case role play (patient-clinician interactions) training video 3. HER2-targeted ADC adverse effects and their management training video

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Daiichi Sankyo

Industry Sponsor

Trials

443

Recruited

493,000+

Hiroyuki Okuzawa

Daiichi Sankyo

Chief Executive Officer

Degree in Social Sciences from Hitotsubashi University

Yuki Abe

Daiichi Sankyo

Chief Medical Officer since 2023

MD

Kaplan North America

Collaborator

Findings from Research

In a study involving 2757 postmenopausal women with hormone receptor-positive early-stage breast cancer, educational materials did not improve treatment compliance with aromatase inhibitors over a 2-year period, with compliance rates remaining similar between groups (82% for both).

The main reason for treatment discontinuation (9% of patients) was side effects related to aromatase inhibitors, highlighting that patient experiences and side effects significantly influence compliance and persistence in treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does patient education work in breast cancer? Final results from the global CARIATIDE study. Markopoulos, C., Neven, P., Tanner, M., et al.[2018]

Antibody-drug conjugates (ADCs) are a promising cancer treatment that combines targeted monoclonal antibodies with cytotoxic agents to deliver drugs directly to cancer cells, minimizing harm to healthy cells.

Despite their targeted approach, ADCs can still cause adverse events due to early payload release or target expression in normal cells, highlighting the need for careful monitoring and dose adjustments to optimize their safety and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Strategies for Mitigating Antibody-Drug Conjugate Related Adverse Events for Precision Therapy. Gouda, MA., Subbiah, V.[2022]

Antibody-drug conjugates (ADCs) are a promising treatment for breast cancer, effectively delivering cytotoxic drugs directly to tumors while minimizing systemic toxicity, making them generally well tolerated.

Despite their benefits, ADCs can cause predictable side effects such as neutropenia and nausea, which require careful monitoring and management to prevent treatment interruptions or dose reductions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Toxicity profile of antibody-drug conjugates in breast cancer: practical considerations. D'Arienzo, A., Verrazzo, A., Pagliuca, M., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Adherence to human epidermal growth factor receptor-2 testing and adjuvant trastuzumab treatment guidelines in Ontario. [2020]

2. England pubmed.ncbi.nlm.nih.gov

Does patient education work in breast cancer? Final results from the global CARIATIDE study. [2018]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluation of a Pharmacist Led Oral Chemotherapy Clinic: A Pilot Program in the Gastrointestinal Oncology Clinic at an Academic Medical Center. [2020]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Adherence and discontinuation of adjuvant hormonal therapy in breast cancer patients: a population-based study. [2013]

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

Treatment of metastatic breast cancer: a large observational study on adherence to French prescribing guidelines and financial cost of the anti-HER2 antibody trastuzumab. [2015]

6. England pubmed.ncbi.nlm.nih.gov

Implementing antibody-drug conjugates (ADCs) in HER2-positive breast cancer: state of the art and future directions. [2022]

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

Strategies for Mitigating Antibody-Drug Conjugate Related Adverse Events for Precision Therapy. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Toxicity profile of antibody-drug conjugates in breast cancer: practical considerations. [2023]

9. England pubmed.ncbi.nlm.nih.gov

Treatment-related adverse events associated with HER2-Targeted antibody-drug conjugates in clinical trials: a systematic review and meta-analysis. [2023]

10. England pubmed.ncbi.nlm.nih.gov

Incidence and risk of fatal adverse events in cancer patients treated with HER2-targeted antibody-drug conjugates: a systematic review and meta-analysis of randomized controlled trials. [2023]

11. Netherlands pubmed.ncbi.nlm.nih.gov

Antibody-drug conjugates in breast cancer: Marching from HER2-overexpression into HER2-low. [2023]

12. England pubmed.ncbi.nlm.nih.gov

Interstitial lung disease associated with anti-HER2 anti-body drug conjugates: results from clinical trials and the WHO's pharmacovigilance database. [2022]

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

Novel development strategies and challenges for anti-Her2 antibody-drug conjugates. [2022]

14. Italy pubmed.ncbi.nlm.nih.gov

Conjugating MMAE to a novel anti-HER2 antibody for selective targeted delivery. [2021]