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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine how educational tools can assist both patients and doctors in managing side effects of specific breast cancer treatments. It focuses on patients with HER2-positive or HER2-low breast cancer who are using or will use HER2-targeted antibody drug conjugates, a type of targeted therapy that attaches to cancer cells. The trial seeks to improve how patients and doctors discuss and handle treatment side effects. Patients with HER2-positive or HER2-low breast cancer who can access online materials and participate virtually may be suitable for this trial. As an unphased trial, it offers patients the opportunity to contribute to valuable research that could enhance communication and management of treatment side effects.

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 prior data suggests that this educational intervention is safe?

Research has shown that certain drugs, such as fam-trastuzumab deruxtecan-nxki and ado-trastuzumab emtansine, have undergone safety testing in breast cancer patients. While these treatments can cause side effects, they are generally considered safe. Common side effects include nausea, tiredness, and low blood cell counts, which can often be managed with proper care.

In one study, many patients responded well to these drugs, indicating their effectiveness and safety. These treatments are already approved for other uses, which helps confirm their safety. Researchers continue to monitor side effects to ensure patient safety and to find better ways to manage and explain them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these educational interventions because they focus on improving communication and understanding between patients and clinicians dealing with HER2-positive or HER2-low breast cancer. Unlike traditional treatments that often emphasize medication and physical therapy, these interventions aim to enhance decision-making through Shared Decision Making (SDM) training and role play, ultimately empowering patients in their care. Additionally, by educating both patients and clinicians about the specific adverse effects and management of HER2-targeted antibody-drug conjugates (ADCs), the trial seeks to optimize treatment outcomes and patient experience. This focus on education and collaboration represents a shift towards more patient-centered care in oncology.

What evidence suggests that this educational intervention is effective for improving adverse event management in HER2+/HER2 low breast cancer patients?

Studies have shown that HER2-targeted treatments can greatly improve outcomes for patients with HER2-positive breast cancer. In one study, the treatment helped more than half of the patients by noticeably reducing their cancer, achieving a 60.9% response rate. Another study found that 27% of patients experienced a reduction in cancer, with 11 out of 41 patients showing partial improvement. These treatments have also shown promise in treating cancer that has spread to the brain in HER2-positive cases. Overall, research suggests these drugs effectively manage HER2-positive breast cancer. Participants in this trial will receive educational interventions related to these treatments, including training videos on shared decision-making, patient-clinician interactions, and managing adverse effects of HER2-targeted antibody drug conjugates. ^{3 4 5 6 7}

Who Is on the Research Team?

Nancy Chan, MD

Principal Investigator

NYU Langone Health

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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]

Citations

1. oncology-central.com oncology-central.com/could-adcs-become-the-new-standard-of-her2-breast-cancer-care/

Could ADCs become the new standard of care for HER2+ ... Results from two phase III trials indicate that antibody-drug conjugates may significantly improve outcomes in patients with HER2-positive ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11700426/

Recent advances of antibody-drug conjugates in treating ... Among 41 patients, DS-1062a achieved an objective remission rate of 27%, including 11 confirmed partial remissions, and an DCR of 85%. These ...

3. nature.com nature.com/articles/s41467-024-48798-w

HER2-targeting antibody drug conjugate FS-1502 in ... In a phase 2 study of T-DXd, the response rate (CR plus PR) was 60.9% in patients with previously treated HER2-positive breast cancer. In a ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2405844024176219

Impact of HER2-targeting antibody drug conjugates in ... At present, some published cohort results show that T-DXd is effective in the treatment of HER2 positive breast cancer brain metastasis, and all ...

5. ehoonline.biomedcentral.com ehoonline.biomedcentral.com/articles/10.1186/s40164-025-00632-9

Antibody-drug conjugates in breast cancer Many ADCs for treatment of breast cancer are currently being tested in late-phase clinical trials, with several encouraging results achieved recently.

6. sciencedirect.com sciencedirect.com/science/article/pii/S0305737224001944

Efficacy and safety of antibody-drug conjugates in ... Antibody-drug conjugates (ADCs) trastuzumab-deruxtecan (T-DXd) and sacituzumab-govitecan (SG) provided significant progression-free survival (PFS) and overall ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9874347/

Treatment-related adverse events associated with HER2 ... This meta-analysis aimed to estimate the mean incidences of treatment-related adverse events of HER2-targeted ADCs and to investigate the differences between ...