Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women

NCT03201861 ↗

Phase 3 Recruiting 762 enrolled RenJi Hospital

RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators hypotheses that paclitaxel combined with cisplatin in a weekly-based regimen as adjuvant chemotherapy is more effective for high risk, HER2 negative breast cancer .

Timeline

Start: 2017-07-27
Primary completion: 2027-08-31
Completion: 2027-12-31

Publications

Background Sparano JA, Zhao F, Martino S, Ligibel JA, Perez EA, Saphner T, Wolff AC, Sledge GW Jr, Wood WC, Davidson NE. Long-Term Follow-Up of the E1199 Phase III Trial Evaluating the Role of Taxane and Schedule in Operable Breast Cancer. J Clin Oncol. 2015 Jul 20;33(21):2353-60. doi: 10.1200/JCO.2015.60.9271. Epub 2015 Jun 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cisplatin	Other / unclassified	25 mg/m2	—
Comparator	Docetaxel	Small molecule	75 mg/m2	Intravenous
Subject	Paclitaxel	Small molecule	80 mg/m2	Intravenous
Comparator	Cyclophosphamide	Other / unclassified	600 mg/m2	Intravenous
Comparator	Epirubicin	Small molecule	90 mg/m2	Intravenous

Addition of Cisplatin to Adjuvant Chemotherapy for Early Stage Breast Cancer in High-Risk Women

Summary

Timeline

Publications

Drugs

Indications