Genomic Signatures to Predict Treatment Response
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Study Type
Study Phase
Study Design
Time Perspective: Prospective
Overall Status
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: 80 Years
Minimum Age: 18 Years
Gender: Female
Criteria: 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.
Institute of Pathology, Med. Univ. Graz
Graz, Austria
Status: Recruiting
Contact: Florentia Peintinger, M.D. -
General Hospital Linz
Linz, Austria
Status: Recruiting
Contact: Peter Schrenk, M.D. - +43 732 7806 -
Start Date
August 2011
Completion Date
September 2020
Medical University of Graz
Medical University of Graz
Record processing date processed this data on July 28, 2015 page