NCT01779479View on ClinicalTrials.gov

Efficacy and Safety of Cabazitaxel Versus Weekly Paclitaxel as Neo-adjuvant Treatment in Patients With Triple Negative or Luminal B/HER2 Normal BC (GENEVIEVE)

PHASE2CompletedINTERVENTIONAL
Enrollment

333

Participants

Timeline

Start Date

February 28, 2013

Primary Completion Date

August 31, 2015

Study Completion Date

February 29, 2016

Conditions
Primary Breast Cancer
Interventions
DRUG

Cabacitaxel

Cabazitaxel 25 mg/m² i.v. (Day 1) every 3 weeks (cycle) as 1-hour i.v infusion for a total of up to 4 cycles over a maximum total treatment period of 15 weeks before surgery

DRUG

Paclitaxel

Paclitaxel 80 mg/m² as 1-hour i.v infusion. Patients will receive weekly (Days 1, 8, 15) paclitaxel administrations for a maximum of 12 infusions for a maximum of 4 cycles over a maximum total treatment period of 15 weeks before surgery (1 cycle = 3 weeks).

Trial Locations (1)

40235

Luisenkrankenhaus, Düsseldorf

All Listed Sponsors
lead

GBG Forschungs GmbH

OTHER

NCT01779479 - Efficacy and Safety of Cabazitaxel Versus Weekly Paclitaxel as Neo-adjuvant Treatment in Patients With Triple Negative or Luminal B/HER2 Normal BC (GENEVIEVE) | Biotech Hunter | Biotech Hunter