drugset / Trial / NCT04224922

Phase II Study of Neoadjuvant Weekly Paclitaxel and Carboplatin Followed by Dose Dense Epirubicin and Cyclophosphamide in Stage II and III Triple Negative Breast Cancer

NCT04224922 ↗

NaSingle-groupOpen-labelTreatment

Summary

This is a prospective Belgian, multi-center, open-label, single-arm phase II study of weekly paclitaxel at a dose of 80mg/m² in combination with weekly carboplatin (AUC=2), for 12 weeks, followed by 4 cycles of dose dense epirubicin at a dose of 90 mg/m² and cyclophosphamide at a dose of 600 mg/m² every 2 weeks (plus Long acting GCSF at day 2) administrated preoperatively in locally advanced operable stage II and III triple negative breast cancer to evaluate tumor response in the breast and the axilla.

Timeline

Start
2015-05
Primary completion
2016-07
Completion
2017-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Carboplatin Small molecule — —
Subject Cyclophosphamide Other / unclassified 600 mg/m2 —
Subject Epirubicin Small molecule 90 mg/m2 —
Subject Paclitaxel Small molecule 80 mg/m2 —

Indications