3000 Participants Needed

Risk Assessment for Breast Cancer

BK
Overseen ByBruce Kimler, Ph.D.
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Carol Fabian, MD
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 find better ways to predict and prevent breast cancer in women at higher risk. Researchers are developing a system that uses various risk factors and markers to aid in monitoring and prevention efforts. Women with twice the normal risk of breast cancer who meet specific health criteria, such as being more than a year from chemotherapy, may be suitable candidates. Participants must agree to regular health checks, including a mammogram and blood tests. The study involves prevention interventions, which are strategies or treatments designed to reduce the risk of developing breast cancer. As a Phase 2 trial, this research measures the effectiveness of prevention strategies in an initial, smaller group, offering participants a chance to contribute to advancements in breast cancer prevention.

Will I have to stop taking my current medications?

The trial requires participants to stop taking NSAIDs (non-steroidal anti-inflammatory drugs) and herbal supplements. It does not specify other medications, so you may not need to stop those, but it's best to check with the trial team.

Is there any evidence suggesting that prevention interventions are likely to be safe for humans?

Research has shown that safety measures effectively reduce risks, such as injuries or illnesses, by creating safer environments.

In breast cancer prevention, the goal is to predict and monitor the effectiveness of these safety measures. While specific data on individual responses to these prevention methods is lacking, the focus remains on ensuring they are safe and well-tolerated.

Overall, the safety of prevention methods depends on their ability to manage risks without causing harm. The aim is to prevent problems before they start, ensuring the methods used do not introduce new risks.12345

Why are researchers excited about this trial?

Researchers are excited about prevention interventions for women at high risk of developing breast cancer because these methods aim to proactively reduce the risk before cancer develops, unlike traditional treatments that focus on addressing cancer after it has formed. Current options, like regular screening and medications such as tamoxifen, primarily focus on early detection or risk reduction through hormonal pathways. These new prevention strategies might include lifestyle interventions, dietary changes, or novel medications that target different biological pathways, potentially offering a more comprehensive approach to risk reduction. The hope is to find more personalized and effective ways to prevent breast cancer in women who are at increased risk, thereby improving outcomes and quality of life.

What evidence suggests that prevention interventions might be effective for breast cancer risk assessment?

Research has shown that regular breast cancer screenings can greatly reduce deaths from the disease. Screening women every two years between ages 50 and 74, for instance, can lower the risk of dying from breast cancer by 26%. Additionally, studies have found that yearly screenings for women aged 40 to 79 can prevent more deaths and extend lives. Personalized approaches, especially those offered remotely to women in rural areas, have also succeeded in increasing screening rates, which can help reduce cancer deaths. Overall, these prevention methods have led to a 44% drop in breast cancer death rates since 1989.678910

Who Is on the Research Team?

CJ

Carol J Fabian, MD

Principal Investigator

University of Kansas Medical Center

Are You a Good Fit for This Trial?

Inclusion Criteria

women with at least 2 times the normal risk of developing breast cancer
between the ages of 30-65 (or within 10 years of youngest age at diagnosis in first degree relative)
greater than six months from ingestion of antihormonal therapy
See 4 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Risk Assessment

Participants undergo integrative breast cancer risk assessment using epidemiologic and biologic risk variables

Ongoing

Biomarker Evaluation

Evaluation of established and potential new breast tissue-based biomarkers for predicting and monitoring response to prevention interventions

Ongoing

Follow-up

Participants are monitored for the development of DCIS and/or invasive cancer

Ongoing

What Are the Treatments Tested in This Trial?

Interventions

  • Prevention Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Carol Fabian, MD

Lead Sponsor

Trials
16
Recruited
4,100+

Citations

Health and Economic Benefits of Breast Cancer Interventions

Compared to no screening, screening every 2 years for women aged 50 to 74 reduces breast cancer deaths by 26%, or 7 deaths averted for every ...

Breast Cancer: The good, the bad, and an important call to ...

The addition of trastuzumab has increased survival in metastatic HER2 positive breast cancer by 16 months, [8] and by 26–37% in early-stage ...

Outcomes of Breast Cancer Screening Strategies Based on ...

Annual screening ages 40–79 years averted the most breast cancer deaths (11.5 per 1000) and gained the most life-years (230 per 1000) compared ...

Comparative Effectiveness of 2 Interventions to Increase ...

These findings suggest that tailored interventions delivered remotely may increase needed screenings in rural women, ultimately decreasing cancer mortality.

Breast Cancer Prevention (PDQ®) - NCI

According to data from the Surveillance, Epidemiology, and End Results (SEER) Program, breast cancer mortality rates declined by 44% from 1989 ...

Safety Management - Hazard Prevention and Control

Effective controls protect workers from workplace hazards; help avoid injuries, illnesses, and incidents; minimize or eliminate safety and health risks.

Safety interventions for the prevention of accidents at work

The objective of this review was to assess the effectiveness of broad categories of safety interventions in preventing accidents at work.

Using workplace safety and health data for injury prevention

This article goes beyond descriptive statistics to explain some ways of using workplace safety and health data to identify the underlying causes of workplace ...

The impact of interventions on health, safety and ...

This study aims to assess the impact of interventions on health, safety, and environmental (HSE) outcomes within the process industry.

Workforce Safety and Well-being: Data Collection

Data collection is key for incident tracking, identifying risks, engaging staff, tailoring interventions, and routine analysis to report findings.