Investigation of Gene Mutations in Patients With Triple-negative and Patients With HER2+ Breast Cancer Adenocarcinoma
NCT ID: NCT04365790
Last Updated: 2023-03-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2013-04-18
2023-09-30
Brief Summary
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Detailed Description
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Statistical analysis: The primary endpoint of the study will be the progression-free survival (PFS), defined as the time from treatment initiation to either the first documented disease progression or death from any cause. Second primary endpoint will be the overall survival (OS), defined as the time from treatment initiation to patient's death or last contact. Survival curves will be estimated using the Kaplan-Meier method and compared across groups with the log-rank test. The associations between the clinicopathological factors to be examined and the mortality rate will be evaluated with hazard ratios estimated with Cox proportional hazards model. The statistical analyses will be completed using the SAS software (SAS for Windows, version 9.3, SAS Institute Inc., Cary, NC).
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Patients with triple-negative breast cancer
Patients with histologically confirmed triple-negative breast cancer. Patients had been treated in Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology
No interventions assigned to this group
Patients with HER2+ positive breast cancer
Patients with histologically confirmed HER2+ breast adenocarcinoma with high risk of recurrence. Patients had been treated in Hellenic Cooperative Oncology Group (HeCOG)-affiliated departments of oncology.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Αny menopausal status is allowed
* triple-negative breast cancer
* HER2+ breast adenocarcinoma
* tumor size \<= 5 cm
* presence of operable axillary lymph nodes or the presence of clinicopathological parameters indicating an intermediate or high risk of recurrence without the presence of infiltrated lymph nodes
* Performance status (PS) = 0 or 1
* adequate bone marrow function , heart, liver and kidney
* no other history of previous neoplasm or other serious illness
18 Years
FEMALE
No
Sponsors
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Hellenic Cooperative Oncology Group
OTHER
Responsible Party
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Principal Investigators
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George Foutzilas, MD
Role: PRINCIPAL_INVESTIGATOR
Hellenic Cooperative Oncology Group
Locations
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George Fountzilas
Athens, , Greece
Countries
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References
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Norton L. Theoretical concepts and the emerging role of taxanes in adjuvant therapy. Oncologist. 2001;6 Suppl 3:30-5. doi: 10.1634/theoncologist.6-suppl_3-30.
Fisher B, Bauer M, Wickerham DL, Redmond CK, Fisher ER, Cruz AB, Foster R, Gardner B, Lerner H, Margolese R, et al. Relation of number of positive axillary nodes to the prognosis of patients with primary breast cancer. An NSABP update. Cancer. 1983 Nov 1;52(9):1551-7. doi: 10.1002/1097-0142(19831101)52:93.0.co;2-3.
Nissen-Meyer R, Kjellgren K, Mansson B. Adjuvant chemotherapy in breast cancer. Recent Results Cancer Res. 1982;80:142-8. doi: 10.1007/978-3-642-81685-7_24.
Meyer JS, McDivitt RW, Stone KR, Prey MU, Bauer WC. Practical breast carcinoma cell kinetics: review and update. Breast Cancer Res Treat. 1984;4(2):79-88. doi: 10.1007/BF01806389.
Kononen J, Bubendorf L, Kallioniemi A, Barlund M, Schraml P, Leighton S, Torhorst J, Mihatsch MJ, Sauter G, Kallioniemi OP. Tissue microarrays for high-throughput molecular profiling of tumor specimens. Nat Med. 1998 Jul;4(7):844-7. doi: 10.1038/nm0798-844.
Skacel M, Skilton B, Pettay JD, Tubbs RR. Tissue microarrays: a powerful tool for high-throughput analysis of clinical specimens: a review of the method with validation data. Appl Immunohistochem Mol Morphol. 2002 Mar;10(1):1-6. doi: 10.1097/00129039-200203000-00001.
Camp RL, Charette LA, Rimm DL. Validation of tissue microarray technology in breast carcinoma. Lab Invest. 2000 Dec;80(12):1943-9. doi: 10.1038/labinvest.3780204.
Other Identifiers
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HE10/13
Identifier Type: -
Identifier Source: org_study_id
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