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Genomic Signatures to Predict Treatment Response (AGO-Austria)

This study is currently recruiting participants.
Verified February 2017 by Medical University of Graz
Sponsor:
ClinicalTrials.gov Identifier:
NCT02032745
First Posted: January 10, 2014
Last Update Posted: February 20, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Medical University of Graz
  Purpose
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.

Condition
Breast Neoplasms

Study Type: Observational
Study Design: Observational Model: Other
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Probability of achieving a negative axillary nodal status [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Breast cancer tissue

Estimated Enrollment: 277
Study Start Date: August 2011
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: September 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Chemo-insensitive
Non-responders to chemotherapy (Probability for pathological negative nodal status)
Chemo-sensitive
Responders to chemotherapy (Probability for pathological negative nodal status)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Breast cancer patients with advanced HER 2 negative breast cancer
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02032745


Contacts
Contact: Florentia Peintinger, M.D. florentia.peintinger@medunigraz.at

Locations
Austria
Institute of Pathology, Med. Univ. Graz Recruiting
Graz, Austria, 8036
Contact: Florentia Peintinger, M.D.       florentia.peintinger@medunigraz.at   
General Hospital Linz Recruiting
Linz, Austria, 4020
Contact: Peter Schrenk, M.D.    +43 732 7806 ext 73288    peter.schrenk@akh.linz.at   
Principal Investigator: Peter Schrenk, M.D.         
Sponsors and Collaborators
Medical University of Graz