drugset / Trial / NCT01564056

Adjuvant Systemic Treatment for (ER)-Positive HER2-negative Breast Carcinoma in Women Over 70 According to Genomic Grade (GG): Chemotherapy + Endocrine Treatment Versus Endocrine Treatment

NCT01564056

Phase 3 Completed 1989 enrolled UNICANCER
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of the study is to evaluate the benefit of adjuvant chemotherapy on overall survival for elderly patients with breast cancer, in a sub group with a high risk of relapse according to Genomic Grade test.

Timeline

Start
2012-04-12
Primary completion
2022-04-11
Completion
2026-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Cyclophosphamide Other / unclassified 600 mg/m2 Intravenous
Subject Docetaxel Small molecule 75 mg/m2 Intravenous
Subject Doxorubicin Other / unclassified 60 mg/m2 Intravenous
Background Tamoxifen Small molecule

Indications