Genomic Signatures to Predict Treatment Response (AGO-Austria)
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ClinicalTrials.gov Identifier: NCT02032745 |
Recruitment Status :
Completed
First Posted : January 10, 2014
Last Update Posted : August 4, 2020
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Condition or disease |
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Breast Neoplasms |
Study Type : | Observational |
Actual Enrollment : | 277 participants |
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 |
Study Start Date : | August 2011 |
Actual Primary Completion Date : | July 2020 |
Actual Study Completion Date : | July 2020 |

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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- 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

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Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
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.

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
Austria | |
Institute of Pathology, Med. Univ. Graz | |
Graz, Austria, 8036 |
Responsible Party: | Peintinger Florentia, MD, Professor, Medical University of Graz |
ClinicalTrials.gov Identifier: | NCT02032745 |
Other Study ID Numbers: |
AGO-35 KLI 406 ( Other Grant/Funding Number: FWF ) |
First Posted: | January 10, 2014 Key Record Dates |
Last Update Posted: | August 4, 2020 |
Last Verified: | August 2020 |
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |