90 Participants Needed

Hormone Therapy for Cardiovascular Health in Breast Cancer Patients

(CROWN Trial)

Recruiting at 2 trial locations
SC
SH
Overseen BySarah Hatcher, MPH
Age: 18 - 65
Sex: Female
Trial Phase: Academic
Sponsor: Duke University
Must be taking: Aromatase inhibitors, SERD
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it allows certain treatments like CDK-inhibitors, PARP inhibitors, and SERDs, so you might be able to continue some medications. It's best to discuss your specific medications with the trial team.

What data supports the effectiveness of the treatment Near-Complete Estrogen Deprivation Therapy for cardiovascular health in breast cancer patients?

The CROWN study is investigating the cardiovascular effects of Near-Complete Estrogen Deprivation Therapy in premenopausal women with breast cancer, focusing on early signs of heart issues to find ways to prevent them. While the study is ongoing, it aims to help balance cancer treatment benefits with potential heart health risks.12345

Is hormone therapy for breast cancer safe for cardiovascular health?

Hormone therapies like aromatase inhibitors and ovarian function suppression, used in breast cancer treatment, may pose a risk of cardiovascular issues, such as heart disease, especially in premenopausal women. Studies are ongoing to better understand these risks and to find ways to manage them effectively.12456

How is Near-Complete Estrogen Deprivation Therapy different from other treatments for breast cancer?

Near-Complete Estrogen Deprivation Therapy is unique because it combines ovarian function suppression with aromatase inhibition, leading to a significant reduction in estrogen levels. This dual approach is newer and may pose a higher risk of cardiovascular issues compared to other hormone therapies, which is why its cardiovascular effects are being closely studied.12457

What is the purpose of this trial?

The purpose of this research study is to understand what effect near complete estrogen deprivation (NCED) therapy has on the heart in breast cancer patients. Investigators want to understand if NCED changes how the heart works.

Research Team

Wake Forest Baptist Health ...

Alexandra Thomas, MD

Principal Investigator

Duke University

Eligibility Criteria

This trial is for women ≤55 years old, premenopausal at breast cancer diagnosis, with Stage I-III HER2 negative or positive breast cancer. They must be starting NCED therapy soon and have an ECOG performance status of 0-2. Patients on certain other non-chemotherapy treatments are eligible. Exclusions include men, those with renal insufficiency, severe heart conditions, metal implants incompatible with MRI, pregnancy, asthma/COPD requiring medication, or allergies to study substances.

Inclusion Criteria

I am starting or have started breast cancer treatment with hormone therapy after menopause induction.
Ability to understand and the willingness to sign an IRB-approved informed consent document
I am being treated with SERD instead of an aromatase inhibitor.
See 8 more

Exclusion Criteria

You are allergic to gadolinium or other contrast agents.
I do not have any severe illnesses or social situations that would stop me from following the study's requirements.
I am experiencing heart symptoms that need urgent investigation.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive near complete estrogen deprivation therapy and undergo cardiac imaging stress tests

24 months
Regular visits for imaging and laboratory tests

Follow-up

Participants are monitored for safety and effectiveness after treatment, including annual long-term follow-up

Up to 5 years
Annual visits

Treatment Details

Interventions

  • Near-Complete Estrogen Deprivation Therapy
Trial Overview The study aims to assess the impact of near-complete estrogen deprivation (NCED) therapy on heart function in breast cancer patients using various diagnostic tools like electrocardiograms (ECGs), stress cardiac MRIs, CT angiograms and lab tests alongside quality of life surveys.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Near-Complete Estrogen Deprivation Therapy ParticipantsExperimental Treatment5 Interventions
Participants will receive cardiac imaging stress tests as well as study laboratory tests to monitor for changes in heart as well 30-day at the end of the study along with annual long-term follow up to 5 years from baseline imaging.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Duke University

Lead Sponsor

Trials
2,495
Recruited
5,912,000+

Wake Forest University Health Sciences

Lead Sponsor

Trials
1,432
Recruited
2,506,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials
3,987
Recruited
47,860,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Findings from Research

The CROWN study is investigating the cardiovascular effects of near-complete estrogen deprivation therapy in 90 premenopausal women with breast cancer, focusing on early signs of cardiovascular disease using advanced imaging techniques over a two-year period.
Understanding the cardiovascular risks associated with aromatase inhibition and ovarian function suppression is crucial for developing strategies to prevent heart-related complications in young women undergoing breast cancer treatment.
Cardiovascular impact of near complete estrogen deprivation in premenopausal women with breast cancer: The CROWN study.Thomas, A., O'Connell, NS., Douglas, E., et al.[2023]
In a study of 16,289 women with early-stage estrogen receptor-positive breast cancer, tamoxifen treatment showed no significant association with the occurrence of serious cardiovascular events like angina, heart attack, heart failure, or stroke during the first five years of therapy.
The findings suggest that tamoxifen does not increase the risk of atherosclerotic events, which is important for evaluating the overall benefits and risks of tamoxifen compared to newer treatments like aromatase inhibitors.
Tamoxifen treatment in Danish breast cancer patients and 5-year risk of arterial atherosclerotic events: a null association.Hernandez, RK., Sørensen, HT., Jacobsen, J., et al.[2022]
In a study of 19 postmenopausal women with advanced ER+/HER2- breast cancer, alternating treatment with 17β-estradiol and aromatase inhibitors showed a clinical benefit rate of 42.1%, indicating potential effectiveness for patients who have not responded to previous therapies.
The presence of ESR1 mutations in tumors was associated with better clinical outcomes, as 57.1% of patients with these mutations experienced clinical benefit from the treatment, suggesting that genetic profiling may help tailor therapy for improved results.
Alternating 17β-Estradiol and Aromatase Inhibitor Therapies Is Efficacious in Postmenopausal Women with Advanced Endocrine-Resistant ER+ Breast Cancer.Schwartz, GN., Kaufman, PA., Giridhar, KV., et al.[2023]

References

Cardiovascular impact of near complete estrogen deprivation in premenopausal women with breast cancer: The CROWN study. [2023]
Tamoxifen treatment in Danish breast cancer patients and 5-year risk of arterial atherosclerotic events: a null association. [2022]
Alternating 17β-Estradiol and Aromatase Inhibitor Therapies Is Efficacious in Postmenopausal Women with Advanced Endocrine-Resistant ER+ Breast Cancer. [2023]
Long term adjuvant endocrine therapy and risk of cardiovascular disease in female breast cancer survivors: systematic review. [2022]
The Cardiovascular Risks Associated with Aromatase Inhibitors, Tamoxifen, and GnRH Agonists in Women with Breast Cancer. [2023]
Adjuvant Hormonotherapy and Cardiovascular Risk in Post-Menopausal Women with Breast Cancer: A Large Population-Based Cohort Study. [2021]
[Hormone therapy, cardio-metabolic profile and cardiotoxicity. Still a dark side of cardio-oncology. Part 1: Breast cancer]. [2022]
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