Cardiometabolic Screening for Breast Cancer Survivors

Overseen By Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Metastatic breast cancer

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

Compensation: Varies

Number of Visits: 6

450 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to help breast cancer survivors by screening for conditions such as prediabetes, diabetes, and heart disease risk. The goal is to detect these issues early and guide participants to resources for management. The trial targets individuals who have had early-stage breast cancer and completed treatment at least three months ago at Johns Hopkins facilities. Participants must be able to read and speak English and must not have metastatic breast cancer. As an unphased trial, this study offers a proactive approach to managing health after cancer treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that this screening program is safe for breast cancer survivors?

Research has shown that breast cancer survivors face a higher risk of developing heart problems due to certain cancer treatments affecting the heart. While specific safety data for heart and metabolism checks in these survivors is lacking, the process is generally safe. Cardiometabolic screening includes tests for high blood sugar and cholesterol, which are routine and well-tolerated by most people.

The screening aims to detect heart problems early. It is not a new treatment but a method to monitor health. As a common practice, the risks are typically very low. The focus is on maintaining health rather than introducing new interventions. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on cardiometabolic screening for breast cancer survivors, a unique approach that could significantly enhance long-term health outcomes. Unlike typical post-cancer care, which often prioritizes cancer recurrence monitoring, this trial emphasizes the early detection of heart and metabolic issues that survivors may face. This proactive screening method aims to identify potential risks much earlier, possibly preventing future cardiovascular problems and improving overall survivor care. By shifting the focus to comprehensive health monitoring, this trial could pave the way for more holistic and preventative care strategies for cancer survivors.

What evidence suggests that this screening program is effective for breast cancer survivors?

Research shows that breast cancer survivors are more likely to develop heart problems, such as heart disease. Studies indicate that these survivors often share common risk factors for both breast cancer and heart issues, including diabetes and high cholesterol. This trial involves cardiometabolic screening for early-stage breast cancer survivors to assess these risks. Screening is crucial because it helps detect problems early, allowing for better management and prevention. For example, one study found that breast cancer survivors had higher rates of diabetes and high blood pressure compared to women without breast cancer. By identifying these risks, survivors can take steps to protect their heart health and improve their overall well-being. ^{1 2 4 6 7}

Who Is on the Research Team?

Jennifer Sheng, M.D.

Principal Investigator

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Are You a Good Fit for This Trial?

This clinical trial is for early-stage breast cancer survivors who have finished their local or systemic therapy at least 3 months ago. Participants must be receiving care through specific Johns Hopkins Medical Institute locations and be able to read and speak English. Those with metastatic breast cancer cannot join.

Inclusion Criteria

I am receiving breast cancer treatment at Johns Hopkins or its associated clinics.

I finished my cancer treatment over 3 months ago.

I have been diagnosed with early stage breast cancer.

Exclusion Criteria

My breast cancer has spread to other parts of my body.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Cardiometabolic Screening Program

Implementation of a screening program for prediabetes, diabetes, dyslipidemia, and cardiovascular disease risk factors in breast cancer survivors

3 years

Regular visits as per program schedule

Follow-up

Participants are monitored for changes in HbA1c, LDL, weight, and patient-reported outcomes at 6 and 12 months

12 months

Assessments at 6 and 12 months

Referral and Management

Participants with identified risk factors are referred to community and institutional resources for management

Ongoing throughout the study

What Are the Treatments Tested in This Trial?

Interventions

• Assess 10 year risk of cardiovascular event
• Baseline
• Follow-Up
• Interpret BMI
• Interpret HbA1c
• Interpret lipid panel and assess other risk factors
• Prescreening
• Recommendations
• Screening and Enrollment

Trial Overview

The study aims to implement a screening program for conditions like prediabetes, diabetes, dyslipidemia, hyperlipidemia, and increased cardiovascular disease risk in breast cancer survivors. It includes various assessments such as HbA1c levels, lipid panels, BMI evaluations, and cardiovascular risk predictions.

How Is the Trial Designed?

Group I: Early stage breast cancer survivors Experimental Treatment 9 Interventions

Patients with history of early stage breast cancer and at least 3 months from completion of local and systemic therapy at Johns Hopkins

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials

578

Recruited

33,600+

Private Philanthropic Funds

Collaborator

Published Research Related to This Trial

A new screening tool has been developed and validated to predict the risk of mortality in older cancer survivors, based on significant cardiometabolic factors such as age, sex, exercise adherence, and smoking habits, using data from 294 participants in the development cohort and 127 in the validation cohort.

The tool demonstrated acceptable discrimination and calibration, indicating it can effectively classify risk levels, but further research is needed to assess its practical application and cost-effectiveness in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and validation of a screening instrument to identify cardiometabolic predictors of mortality in older individuals with cancer: Secondary analysis of the Australian Longitudinal Study of Ageing (ALSA). Lim, E., Miller, M., Kaambwa, B., et al.[2019]

Tamoxifen, while effective in treating estrogen receptor-positive early breast cancer, may increase body fat and diabetes risk but can lower LDL cholesterol and has a neutral or beneficial effect on cardiovascular events.

Aromatase inhibitors do not show consistent adverse effects on cardiometabolic risk factors or cardiovascular events, but more research is needed to fully understand their impact compared to tamoxifen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiometabolic Effects of Endocrine Treatment of Estrogen Receptor-Positive Early Breast Cancer. Cheung, YM., Ramchand, SK., Yeo, B., et al.[2020]

Breast cancer survivors have a higher risk of developing hypertension and diabetes compared to women without breast cancer, with significant differences observed after 2 years and persisting for up to 10 years.

Specific treatments, such as chemotherapy, left-sided radiation, and endocrine therapy, further increase the risk of diabetes and hypertension in breast cancer survivors, particularly among those with a normal body mass index (BMI).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk of Cardiometabolic Risk Factors in Women With and Without a History of Breast Cancer: The Pathways Heart Study. Kwan, ML., Cheng, RK., Iribarren, C., et al.[2023]

Women diagnosed with hormone receptor-positive Stage I-III breast cancer showed a significant increase in body mass index (BMI) of ≥5% from diagnosis to follow-up, particularly among those who were overweight at diagnosis, indicating a need for early anti-obesity interventions.

The study found that women with a higher baseline BMI were more likely to experience annual increases in BMI, highlighting the importance of monitoring weight changes in breast cancer survivors to improve overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Weight Gain after Hormone Receptor-Positive Breast Cancer. Goyal, A., Milner, GE., Cimino-Mathews, A., et al.[2022]

A telephone-delivered weight loss intervention for women with a BMI of 25-40 kg/m2 after breast cancer treatment resulted in a significant average weight loss of 3.1 kg compared to usual care, demonstrating its efficacy.

The intervention was found to be feasible and acceptable, with high participant satisfaction, and only one reported adverse event, indicating it is a safe option for this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Living Well after Breast Cancer™ Pilot Trial: a weight loss intervention for women following treatment for breast cancer. Reeves, M., Winkler, E., Mccarthy, N., et al.[2022]

In a study involving 1,228 breast cancer cases over 516,452 person-years of follow-up, no significant overall association was found between individual or combined cardiometabolic factors (like obesity, diabetes, hypertension, and high cholesterol) and breast cancer incidence in U.S. black women.

However, among postmenopausal women, there was a notable association, with increased incidence rates of breast cancer linked to having multiple cardiometabolic factors, suggesting that these factors may play a role in breast cancer risk specifically in this group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiometabolic factors and breast cancer risk in U.S. black women. Bosco, JL., Palmer, JR., Boggs, DA., et al.[2022]

Older breast cancer survivors (n = 1361) do not have a significantly higher risk of cardiovascular disease (CVD) compared to matched women without breast cancer, indicating that breast cancer status alone is not a strong predictor of CVD risk.

The study highlights that preexisting conditions like smoking, diabetes, and hypertension are much stronger predictors of CVD risk, suggesting that managing these comorbidities is crucial for improving long-term health outcomes in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comorbidities and cardiovascular disease risk in older breast cancer survivors. Haque, R., Prout, M., Geiger, AM., et al.[2022]

In a study of 8,641 women with early-stage breast cancer, having multiple cardiometabolic risk factors was linked to a higher risk of death from cardiovascular disease and other causes, but not from breast cancer itself.

Specifically, increased waist circumference was associated with a 28% higher risk of cardiovascular mortality and a 32% higher risk of other-cause mortality, while showing only a slight and non-significant increase in breast cancer mortality risk.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiometabolic risk factors and survival after breast cancer in the Women's Health Initiative. Simon, MS., Beebe-Dimmer, JL., Hastert, TA., et al.[2021]

Breast cancer survivors are increasingly at risk of dying from cardiovascular disease, which is now the leading cause of non-cancer related mortality in this group, highlighting the importance of managing cardiometabolic risk factors like excess body fat.

The review emphasizes the need for weight management strategies in breast cancer survivors, as weight gain after diagnosis can negatively impact both cancer recurrence and overall health outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The relation between excess adiposity and breast cancer in women: Clinical implications and management. Hurtado, MD., Tama, E., D'Andre, S., et al.[2023]

A 12-week diet and exercise intervention for 42 overweight/obese breast cancer survivors led to significant improvements in metabolic risk biomarkers and insulin resistance indicators, suggesting that lifestyle changes can positively impact health post-cancer.

The study found moderate correlations between improvements in metabolic biomarkers and reductions in body mass index and increases in cardiorespiratory fitness, highlighting the importance of weight management and physical activity in breast cancer survivorship.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in metabolic risk, insulin resistance, leptin and adiponectin following a lifestyle intervention in overweight and obese breast cancer survivors. Travier, N., Buckland, G., Vendrell, JJ., et al.[2019]

A study of 84,969 women diagnosed with breast cancer revealed a significantly increased risk of developing several chronic conditions, including leukemia, endometrial cancer, and cardiomyopathy, compared to a large control group of 1,057,674 women without breast cancer.

The elevated risks for these chronic conditions persisted for over 5 years after breast cancer diagnosis, highlighting the need for ongoing monitoring and management of long-term health issues in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Temporal patterns of chronic disease incidence after breast cancer: a nationwide population-based cohort study. Kang, D., Kang, M., Hong, YS., et al.[2022]

In a study of 158 postmenopausal breast cancer survivors, 48.1% were diagnosed with metabolic syndrome (MetS), highlighting a significant risk for this population.

The most common factor for MetS was abdominal obesity, with 54.4% of participants affected, and those with MetS experienced significant weight gain since their cancer diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Metabolic syndrome in postmenopausal breast cancer survivors]. Nahas, EA., de Almeida, Bda R., Buttros, Dde A., et al.[2019]

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