Ultrasound-Guided Biopsy for Breast Cancer

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: M.D. Anderson Cancer Center

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

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to compare the effectiveness of an ultrasound-guided biopsy in detecting signs of breast cancer to findings from surgery. The technique focuses on gathering information about the cancer before surgery. It may suit patients diagnosed with triple-negative or HER2 amplified breast cancer who are scheduled for preoperative treatment and surgery. As an unphased trial, it offers patients the chance to contribute to research that could enhance diagnostic techniques before surgery.

Will I have to stop taking my current medications?

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

What prior data suggests that this ultrasound-guided biopsy is safe for breast cancer patients?

Research has shown that ultrasound-guided biopsies are safe and generally well-tolerated. One study involving 677 patients who underwent ultrasound-guided breast biopsies reported no major problems, indicating the procedure's usual safety. Another study found that using a larger needle for the biopsy was also safe and effective for examining tissue.

A review of multiple studies found that ultrasound-guided biopsies accurately detect breast cancer. Complications are rare and usually minor, such as small bruises. Overall, this evidence suggests that ultrasound-guided biopsy is a safe choice for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ultrasound-guided biopsy technique for breast cancer because it allows for precise targeting of the tumor site, potentially leading to more accurate diagnosis compared to traditional methods like mammography or MRI-guided biopsies. This method uses real-time imaging, which helps in avoiding unnecessary tissue removal and can be less invasive. Additionally, it can be performed more quickly and conveniently, potentially reducing patient discomfort and anxiety associated with longer procedures.

What evidence suggests that an ultrasound-guided biopsy is effective for detecting breast cancer?

Studies have shown that ultrasound-guided biopsies are highly effective for detecting breast cancer. Research indicates that this method correctly identifies cancer 98% of the time and rarely produces false positives. One study demonstrated that this approach can help avoid surgery in about 85% of cases, offering a less invasive option. Specifically, patients who underwent ultrasound-guided biopsies had a 97.2% rate of being cancer-free after three years. These findings suggest that ultrasound-guided biopsies provide a reliable and efficient way to diagnose breast cancer. ^{3 4 5 6 7}

Who Is on the Research Team?

Henry M. Kuerer

Principal Investigator

M.D. Anderson Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a specific type of breast cancer (either triple negative or HER2 amplified) at various stages. Participants are those who have received preoperative therapy and are planning to undergo surgery.

Inclusion Criteria

You have a specific type of breast cancer and are currently getting treatment before surgery.

Exclusion Criteria

This criterion is not applicable.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Biopsy

Participants undergo an ultrasound-guided biopsy of the tumor site to collect cells and tissue samples

1 day

1 visit (in-person)

Surgery and Post-operative Care

Participants have the planned surgery and receive post-operative care

Varies based on individual recovery

Follow-up

Participants are monitored for general health and surgery outcomes through routine follow-up visits

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound-Guided Biopsy

Trial Overview The study is examining the effectiveness of using ultrasound-guided biopsy to detect breast cancer compared to traditional surgical methods. It aims to see if this less invasive technique can reliably find evidence of disease.

How Is the Trial Designed?

Group I: Ultrasound-Guided Biopsy of Tumor Site Experimental Treatment 1 Intervention

Ultrasound-guided biopsy of the tumor site performed before scheduled surgery.

Who Is Running the Clinical Trial?

M.D. Anderson Cancer Center

Lead Sponsor

Trials

3,107

Recruited

1,813,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8575702/

A systematic review and meta-analysis: value of ultrasound ... The results of the meta-analysis were stable, and VAB showed high sensitivity (98%) and specificity (100%), indicating that it is a promising alternative to ...

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1546144025002510

Outcomes of Implementation of a Same-Day Breast Biopsy ... Conclusion. Implementation of a SDB program is effective in reducing overall diagnostic delays after a breast biopsy recommendation for patients seen in safety- ...

3. eurjbreasthealth.com eurjbreasthealth.com/articles/performance-benchmark-metrics-and-clinicopathologic-outcomes-of-mri-guided-breast-biopsies-a-systematic-review-and-meta-analysis/ejbh.galenos.2022.2022-12-1

A Systematic Review and Meta-Analysis MRI-guided breast biopsy is an efficient, highly accurate technique with high technical success [99.10%, 95% confidence interval (CI): 97.89–99.62%]

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/full/10.1002/cai2.158

Effectiveness of Ultrasound‐Guided Vacuum‐Assisted ... Ninety-six patients with breast cancer had undergone follow-up treatment, achieving a 3-year disease-free survival rate of 97.2% and a 3-year ...

5. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiology.208.3.9722851

US-guided core breast biopsy: use and cost-effectiveness. RESULTS: US-guided core biopsy obviated a surgical procedure in 128 (85%) of 151 women. The mean adjusted direct cost saving per US-guided core biopsy was +744 ...

6. jacr.org jacr.org/article/S1546-1440(25)00251-0/fulltext

Outcomes of Implementation of a Same-Day Breast Biopsy ... A total of 677 patients received recommended US-guided breast biopsies during the study period, with 233 patients in the phase-in group, 306 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2615308/

The Safety and Efficiency of the Ultrasound-guided Large ... In conclusion, the US-guided large needle (14G) core biopsy of the axilla lesion is safe and effective for the pathological evaluation. The core biopsy could ...