NCT04365790 - Clinical Trial References

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Citation(s)

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.
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.
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.
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.
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.
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.
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.

Investigation of Gene Mutations or Changes in Protein Expression,as Biomarkers With Prognostic/Predictive Value, in Patients With Triple-negative and in Patients With HER2+ Breast Cancer Adenocarcinoma,Who Underwent Intensive Adjuvant Chemotherapy

Details for clinical trial NCT04365790

Clinical trial NCT04365790 - References