Cardiopulmonary Exercise Testing for Breast Cancer

AY
JL
Overseen ByJennifer Liu, MD
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Memorial Sloan Kettering Cancer Center
Must be taking: HER2-targeted therapy
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate the heart and lung function of women during a special exercise test after experiencing mild heart problems from treatment for HER2-positive breast cancer. Researchers seek to determine if this test can predict future heart and lung health while treatment continues. Women diagnosed with HER2-positive breast cancer who have experienced mild heart issues, such as a slight drop in heart function, after starting specific cancer treatments may be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant findings.

Will I have to stop taking my current medications?

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

What prior data suggests that cardiopulmonary exercise testing is safe for women with mild cardiotoxicity?

Research has shown that the cardiopulmonary exercise test (CPET) is generally safe for women treated for breast cancer. Studies have found that a supervised exercise program, such as CPET, can improve heart and lung fitness in women with HER2-positive breast cancer without causing harm. These programs were safe and even enhanced participants' exercise capacity.

For women with mild heart issues from cancer treatment, CPET can monitor heart and lung function. This test measures how the body uses oxygen during exercise, providing doctors with a clearer picture of heart and lung health.

There are no specific reports of harmful effects from CPET in people with breast cancer. Overall, evidence suggests that CPET is well-tolerated and can be a useful tool for understanding heart health after cancer treatment.12345

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how cardiopulmonary exercise testing and echocardiography can be used to monitor heart health in women with HER2-positive breast cancer who have developed mild heart issues from their cancer treatment. Unlike standard heart monitoring methods, this approach could provide a more dynamic view of heart function during physical activity, helping to identify early signs of heart strain before they become serious. By focusing on exercise testing, this trial has the potential to lead to better personalized care plans that proactively address heart health while continuing cancer treatment.

What evidence suggests that cardiopulmonary exercise testing is effective for predicting heart and lung function in HER2-positive breast cancer patients with mild cardiotoxicity?

Studies have shown that cardiopulmonary exercise testing (CPET) effectively assesses heart and lung function in breast cancer patients. In this trial, participants with HER2-positive breast cancer who developed mild cardiotoxicity during HER2-targeted therapy will undergo CPET. Research indicates that exercise can enhance fitness and improve the quality of life for women treated for breast cancer. This is crucial because treatments like trastuzumab, used for HER2-positive breast cancer, can sometimes cause mild heart problems. By measuring oxygen use during exercise, CPET predicts heart and lung performance. This can be particularly beneficial for patients with mild heart issues, as it may guide treatment decisions and improve health outcomes.12346

Who Is on the Research Team?

AY

Anthony Yu, MD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

Inclusion Criteria

Female
Diagnosed with a HER2-positive solid tumor (stage I-IV)
Left ventricular dysfunction prior to the start of HER2-targeted therapy, defined by a LVEF < 53% (or lower limit of normal), or diagnosed with mild cardiotoxicity associated with HER2-targeted therapy, defined by an absolute decrease in LVEF ≥ 10% from pre-treatment to < 53%
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo cardiopulmonary exercise testing (CPET) to evaluate baseline VO2peak

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after baseline assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Cardiopulmonary Exercise Test
  • Echocardiogram
  • Echocardiography

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Participants with HER2-positive breast cancerExperimental Treatment3 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials
1,998
Recruited
602,000+

Citations

Study of Cardiopulmonary Exercise Testing in Women Who ...

Participants with HER2-positive breast cancer who have developed mild cardiotoxicity during HER2-targeted therapy, defined by a decline in LVEF > 10% to < 53% ...

Self-Reported Physical Activity, QoL, Cardiac Function, and ...

Women treated for breast cancer are at risk for worsening health-related quality of life (QoL), cardiac function, and cardiorespiratory fitness.

Cardiorespiratory Fitness in Breast Cancer Patients

Recent evidence suggests that exercise training is an effective intervention to improve CRF as well as quality of life, physical functioning/ ...

Long-term Cardiopulmonary Consequences of Treatment ...

Importance Trastuzumab improves outcomes in patients with ERBB2-positive (formerly HER2) breast cancer but is associated with treatment-induced ...

Validity of Estimated Cardiorespiratory Fitness in Patients ...

The aim of this study was to evaluate the validity of estimated Vo2peak in women with primary breast cancer and to develop oncology-specific estimated Vo2peak ...

Cardiotoxicity is mitigated after a supervised exercise ...

To conclude, a 12-week supervised exercise regimen was safe and improved the cardiopulmonary fitness in HER2-positive breast cancer patients ...