Genomic Signatures to Predict Treatment Response

Completed

• Conditions: Breast Neoplasms

• Registration Number: NCT02032745
• Lead Sponsor: Medical University of Graz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Study First Submitted: 2013-11-17
• Study First Submitted QC: 2014-01-07
• Study First Posted: 2014-01-10
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-02
• Last Update Posted: 2020-08-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 277

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Probability of achieving a negative axillary nodal status	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.

Trial Locations

Locations (1)

Institute of Pathology, Med. Univ. Graz; 🇦🇹 Graz, Austria