Clinical trial NCT02032745: Genomic Signatures to Predict Treatment Response
Official title: Prospective Validation of Genomic Signatures to Predict Treatment Response in the Axillary Nodes After Neoadjuvant Chemotherapy in Patients With HER2-negative Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Neoplasms
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2014-01-10
Enrollment: 277
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Breast cancer patients with advanced HER 2 negative breast cancer

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.


Eligibility 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.

Primary outcomes:
measure: Probability of achieving a negative axillary nodal status
timeFrame: at time of surgery
Secondary outcomes:
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Institute of Pathology, Med. Univ. Graz
Study officials:
References:
citation: Hatzis C, Pusztai L, Valero V, Booser DJ, Esserman L, Lluch A, Vidaurre T, Holmes F, Souchon E, Wang H, Martin M, Cotrina J, Gomez H, Hubbard R, Chacon JI, Ferrer-Lozano J, Dyer R, Buxton M, Gong Y, Wu Y, Ibrahim N, Andreopoulou E, Ueno NT, Hunt K, Yang W, Nazario A, DeMichele A, O'Shaughnessy J, Hortobagyi GN, Symmans WF. A genomic predictor of response and survival following taxane-anthracycline chemotherapy for invasive breast cancer. JAMA. 2011 May 11;305(18):1873-81. doi: 10.1001/jama.2011.593.
citation: Peintinger F, Anderson K, Mazouni C, Kuerer HM, Hatzis C, Lin F, Hortobagyi GN, Symmans WF, Pusztai L. Thirty-gene pharmacogenomic test correlates with residual cancer burden after preoperative chemotherapy for breast cancer. Clin Cancer Res. 2007 Jul 15;13(14):4078-82. doi: 10.1158/1078-0432.CCR-06-2600.