Genomic Signatures to Predict Treatment Response
Conditions
Breast Neoplasms
Conditions: official terms
Breast Neoplasms
Study Type
Observational
Study Phase
N/A
Study Design
Time Perspective: Prospective
Overall Status
Recruiting
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.
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.
Locations
Institute of Pathology, Med. Univ. Graz
Graz, Austria
Status: Recruiting
Contact: Florentia Peintinger, M.D. - florentia.peintinger@medunigraz.at
General Hospital Linz
Linz, Austria
Status: Recruiting
Contact: Peter Schrenk, M.D. - +43 732 7806 - peter.schrenk@akh.linz.at
Start Date
August 2011
Completion Date
September 2020
Sponsors
Medical University of Graz
Source
Medical University of Graz
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page