Median initial tumor size was 3 centimeters and 47.1 percent of patients had nodal metastasis at the time of diagnosis. After NST, the median residual tumor size was 0.9 cm, with 94.1 percent of patients having no palpable abnormality.
Researchers found that following NST, VACB combined with FNA had 100 percent accuracy, 0 percent FNR, and 100 percent predictive value for determination of residual disease. Grade 1 biopsy associated adverse events, including bleeding, hematoma and bruising, occurred in six patients (17.6 percent).
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"With this knowledge, there's an obligation to test whether no surgery, or 'ultimate breast conserving therapy,' is safe," says Kuerer.
The accuracy of the preliminary findings led MD Anderson's Institutional Review Board to approve a Phase II clinical trial, which soon is to open at MD Anderson and then across the MD Anderson Cancer Network. The study will enroll women with Stage I and II HER2-positive and triple negative breast cancer. Participants who achieve image-guided, biopsy-proved pCR after NST will undergo whole-breast radiation, without surgery. The trial will be the first using image-guided biopsies in this setting and not include surgery.
"There is an urgency to test whether surgery is needed. In conversations with my patients, many express concerns about overtreatment. They want the most personalized care with as minimal treatment as possible," says Kuerer. "If these findings prove to be true, it would be groundbreaking for patients - both physically and psychologically."
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