Genomic Signatures to Predict Treatment Response

NCT ID: NCT02032745

Last Updated: 2020-08-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 277 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-08-31
• Study Completion Date: 2020-07-31

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.

Conditions

Breast Neoplasms

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

Chemo-insensitive

Non-responders to chemotherapy (Probability for pathological negative nodal status)

No interventions assigned to this group

Chemo-sensitive

Responders to chemotherapy (Probability for pathological negative nodal status)

No interventions assigned to this group

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Graz

OTHER

Sponsor Role: lead

Responsible Party

Peintinger Florentia, MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Institute of Pathology, Med. Univ. Graz

Graz, , Austria

Countries

Austria

References

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.

Reference Type: BACKGROUND

PMID: 21558518 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 17634532 (View on PubMed)

Other Identifiers

KLI 406

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AGO-35

Identifier Type: -

Identifier Source: org_study_id