Blood Test for Breast Cancer

(BEACON Trial)

Recruiting at 2 trial locations

Overseen By Keira Frosst

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Dr. Christopher Mueller

Disqualifiers: Exclusive bone metastases

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

Compensation: Varies

Number of Visits: 11

Duration: 6 months

150 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial evaluates how well a blood test called mDETECT can track the response of women with metastatic breast cancer to their treatment. Researchers aim to determine if this blood test can effectively indicate whether the cancer treatment is working. Women with breast cancer that has returned or spread and cannot be treated with surgery or radiation might be suitable candidates for this study. This trial could help doctors better understand and adjust treatments for those with advanced breast cancer. As a Phase 2 trial, it focuses on assessing the blood test's effectiveness in an initial, smaller group, offering participants a chance to contribute to significant advancements in cancer treatment.

Do I need to stop my current medications for this trial?

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

What prior data suggests that the mDETECT breast cancer blood test is safe for monitoring treatment response?

Research shows that the mDETECT breast cancer blood test safely tracks treatment effectiveness for women with metastatic breast cancer. This noninvasive test involves only a simple blood sample.

Although specific safety data for the mDETECT test is not mentioned in the sources, blood tests generally pose minimal difficulty for patients. Serious side effects are rare, with the most common issue being minor bruising or discomfort at the needle site.

For those considering joining the trial, the mDETECT blood test appears to be a low-risk option. It is designed to help doctors closely monitor the effectiveness of cancer treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the mDETECT breast cancer blood test because it offers a non-invasive way to monitor metastatic breast cancer treatment. Unlike traditional methods that may require repeat imaging or biopsies, this blood test can potentially provide real-time insights into how well a treatment is working without the need for invasive procedures. This could lead to more timely adjustments in treatment plans, helping doctors tailor therapies to each patient's unique cancer dynamics more effectively.

What evidence suggests that the mDETECT breast cancer blood test is effective for monitoring treatment response in metastatic breast cancer?

Research has shown that the mDETECT breast cancer blood test effectively monitors advanced breast cancer. In studies, this test correctly identified cancer in 83% of cases and ruled it out in 92% of cases, demonstrating high accuracy. This accuracy is crucial for tracking treatment effectiveness. The test detects specific DNA markers in the blood, allowing doctors to assess cancer's response to treatment. This blood test could simplify managing and adjusting treatment plans for patients with metastatic breast cancer. ^{2 6 7 8 9}

Who Is on the Research Team?

Christopher R Mueller, Ph.D.

Principal Investigator

Queen's University

Are You a Good Fit for This Trial?

Inclusion Criteria

I am a woman over 18 with breast cancer that has spread and cannot be removed by surgery or cured with radiation.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline

Baseline blood draw to measure initial ctDNA levels before treatment

1 week

1 visit (in-person)

Treatment

Participants undergo treatment for metastatic breast cancer with regular blood draws to monitor ctDNA levels

6 months

Weekly blood draws for 8 weeks, then monthly

Radiographic Assessment

CT-scans performed every 3 months to assess treatment effectiveness

6 months

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• mDETECT breast cancer blood test

Who Is Running the Clinical Trial?

Dr. Christopher Mueller

Lead Sponsor

Trials

1

Recruited

150+

Dr. Christopher Mueller

Lead Sponsor

Trials

1

Recruited

150+

Queen's University

Collaborator

Kingston Health Sciences Centre

Collaborator

Trials

312

Recruited

112,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Queen's University

Collaborator

Trials

382

Recruited

122,000+

Citations

1. trialx.com trialx.com/clinical-trials/listings/229641/using-a-blood-test-to-monitor-metastatic-breast-cancer-treatment/

Using a Blood Test to Monitor Metastatic Breast Cancer ... While survival rates for women with metastatic breast cancer have almost doubled in the last 20 years, the 5-year survival rate is about 25%.

2. nature.com nature.com/articles/s41698-021-00198-9

A DNA methylation-based liquid biopsy for triple-negative ... The mDETECT TNBC assay is a liquid biopsy able to quantitatively detect all TNBC cancers and has the potential to improve the management of patients with this ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11785667/

the potential of multi-cancer early detection (MCED ... The results showed that the blood test alone had sensitivity, specificity, PPV, and NPV of 27.1%, 98.9%, 19.4%, and 99.3%, respectively. Whereas ...

4. hopkinsmedicine.org hopkinsmedicine.org/news/newsroom/news-releases/2022/06/liquid-biopsy-detects-dna-markers-in-advanced-breast-cancer-within-five-hours

Liquid Biopsy Detects DNA Markers in Advanced Breast ... The test was found to correctly detect cancer 83% of the time, and correctly rule out cancer 92% of the time, for an overall diagnostic accuracy ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/full/10.3322/caac.21833

Cancer screening with multicancer detection tests: A ... A positive MCD signal was detected in 92 individuals (1.4%), of whom 57 had a false-positive result and 35 had a true-positive result (0.5% of ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT05804578

Using a Blood Test to Monitor Metastatic Breast Cancer ... The goal of this observational study is to assess the effectiveness of the mDETECT breast cancer blood test in women undergoing treatment for metastatic breast ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5577414/

Rapid and Sensitive Detection of Breast Cancer Cells in ... Given the high sensitivity of this technology, we reasoned that nuclease-activated probes could be useful in detecting low numbers of cancer cells in blood.

8. friendsofcancerresearch.org friendsofcancerresearch.org/publication/multi-cancer-early-detection-screening-tests-considerations-for-use-of-real-world-data/

Multi-Cancer Early Detection Screening Tests Cancers that are detected in late stages generally have a worse prognosis compared to cancers detected in earlier stages, when tumors are more amenable to ...

9. nature.com nature.com/articles/s41598-024-73783-0

Noninvasive multi-cancer detection using blood-based cell ... Here we report a miRNA-based blood test for multi-cancer early detection based on examination of serum microRNA microarray data from cancer patients and ...