Molecular Breast Imaging: Evaluation of a New Technique Using Scintimammography as an Additional Diagnostic Tool for Women Undergoing Neoadjuvant Therapy for Breast Cancer - A Pilot Study
Adjuvant therapy after surgery for breast cancer has provided significant benefits to
patients at risk for relapse. However, the success of therapy for each individual patient
will often take years to reveal. Preoperative (neoadjuvant) medical therapy is very potent
as an initial treatment for inoperable and large operable breast cancers. Tumor regression
can be achieved in the great majority of patients and downstaging frequently reduces the
need for mastectomy and it has become clear that pathologic complete response is a good
prognostic marker. Data from current trials suggest that survival is at least as good with
preoperative as with postoperative neoadjuvant therapies (1). With this observation
preoperative medical therapy has the advantage over post-operative neoadjuvant therapy that
it can be used as a short term surrogate marker for long-term outcome. With this
translational approach, the therapy for each patient can be more targeted and individualized
leading to higher success rates; and further, new therapies for early breast cancer can be
assessed much more quickly than is currently possible through protracted trials of
neoadjuvant therapy (2). This approach is therefore being increasingly utilized in patients
with lower stage breast cancers.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
To document that pre- and post-neoadjuvant therapy tumor size can be satisfactorily assessed by molecular breast imaging and corresponds to tumor size evaluation by conventional breast imaging procedures (mammogram, ultrasound, MRI).
Up to 6 months
Dietlind L. Wahner-Roedler, M.D.
United States: Institutional Review Board
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