Breast Neoplasms
Conditions
Brief summary
A genomic test was developed to predict chemo-sensitivity to taxane-anthracycline-based chemotherapy as neoadjuvant treatment. The primary aim of this study is to prospectively evaluate the microarray-based, genomic test as a predictor of axillary lymph node response. Also, to determine whether the probability of achieving negative axillary nodes, is sufficiently high for patients whose breast cancer is predicted to be chemo-sensitive to support omitting axillary dissection.
Interventions
None listed
Sponsors
Medical University of Graz
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical status of lymph nodes must be available * Sonographical status of lymph nodes must be available * Patients must consent to documentation of cancer treatment * Histologic diagnosis of invasive breast cancer, clinical stage T1-4, M0 (non-inflammatory T4c) * Patients scheduled for neoadjuvant chemotherapy * Treatment with a 3-weekly FEC or AC regimen (3-4 cycles) followed by 3-4 cycles of q3 weekly docetaxel or paclitaxel. * Local HER2 status of tumor biopsy must be negative.
Exclusion criteria
* The patient has a prior history of invasive or metastatic breast cancer. * The patient had prior excisional biopsy of the primary invasive breast cancer. * The patient had prior ipsilateral sentinel axillary lymph node biopsy for breast cancer. * The patient cannot safely or feasibly undergo biopsy of the primary tumor. * The patient has a diagnosis of Stage IV (distant metastatic) breast cancer. * The patient has proven HER2-positive breast cancer, defined as a pathology report of amplification of the gene or 3+ score for immunohistochemical staining.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Probability of achieving a negative axillary nodal status | at time of surgery | The overall rate of pathologic lymph node-negative status (pLN0) will be evaluated, including clinically lymph node-negative (cLN-) and lymph node-positive (cLN+) patients. For sample size calculation we will consider the rate of nodal conversion from clinically node-positive (cLN+) before treatment to pathologic node-negative (pLN0) after the completion of neoadjuvant chemotherapy. Patients who are clinically node positive (cLN+) will be evaluated for nodal response, i.e. conversion to pLN0 status. We assume that 30% of these patients will be predicted by the genomic predictor as responders (i.e. pLN0 status) after neoadjuvant chemotherapy, and that 70% of them will actually achieve pLN0 status. The study will be sized to have 80% power to detect observed response (pLN-negative) rates \> 50% in cLN-positive patients after neoadjuvant chemotherapy at a 95% confidence level (one sided). Probability will be measured in percent. |
Countries
Austria
Outcome results
None listed