drugset / Trial / NCT02400567

Efficacy of Letrozole + Palbociclib Combination as Neoadjuvant Treatment of Stage II-IIIA PAM 50 ROR-defined Low or Intermediate Risk Luminal Breast Cancer, in Postmenopausal Women

NCT02400567

RandomizedParallel-groupOpen-labelTreatment

Summary

The investigators propose in the present study an innovative approach, combining the most recent therapeutic opportunities in high risk ER+ breast cancer with the most recent and innovative diagnostic approaches such as the PAM50 signature and the RCB tumor response evaluation method. In line with the most recent recommendations on targeted anticancer therapies, the investigators have designed a parallel phase II randomized trial with early stopping rules 26, which will able in the meantime to build a unique prospective collection of tumor tissue, pre- and post-treatment.

Timeline

Start
2015-01
Primary completion
2018-01
Completion
2020-09

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified 500 mg/m2
Comparator Epirubicin Small molecule 100 mg/m2
Comparator Fluorouracile Unknown 500 mg/m2
Subject Letrozole Other / unclassified 2.5 mg
Subject Palbociclib Small molecule 125 mg

Indications