- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02032745
Genomic Signatures to Predict Treatment Response (AGO-Austria)
August 2, 2020 updated by: Peintinger Florentia, MD, Medical University of Graz
Prospective Validation of Genomic Signatures to Predict Treatment Response in the Axillary Nodes After Neoadjuvant Chemotherapy in Patients With HER2-negative Breast Cancer
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.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
277
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Graz, Austria, 8036
- Institute of Pathology, Med. Univ. Graz
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
Breast cancer patients with advanced HER 2 negative breast cancer
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Chemo-insensitive
Non-responders to chemotherapy (Probability for pathological negative nodal status)
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Chemo-sensitive
Responders to chemotherapy (Probability for pathological negative nodal status)
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Probability of achieving a negative axillary nodal status
Time Frame: at time of surgery
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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.
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at time of surgery
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2011
Primary Completion (ACTUAL)
July 1, 2020
Study Completion (ACTUAL)
July 1, 2020
Study Registration Dates
First Submitted
November 17, 2013
First Submitted That Met QC Criteria
January 7, 2014
First Posted (ESTIMATE)
January 10, 2014
Study Record Updates
Last Update Posted (ACTUAL)
August 4, 2020
Last Update Submitted That Met QC Criteria
August 2, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AGO-35
- KLI 406 (OTHER_GRANT: FWF)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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