Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer
NCT01180335 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 303
Last updated 2012-03-16
Summary
This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with breast cancer.
Conditions
Interventions
- DRUG
-
4 cycles FEC followed by 4 cycles docetaxel
- DRUG
-
Genomic driven chemotherapy
High DLD30 receive 3 months weekly paclitaxel followed by 4 FEC, patients with high TOP2A receive 4FEC then 4 docetaxel, patients with low DLD30 and low TOP2A are treated with 6 cycles of docetaxel-capecitabine.
Sponsors & Collaborators
-
Institut Curie
collaborator OTHER -
Gustave Roussy, Cancer Campus, Grand Paris
lead OTHER
Principal Investigators
-
Florence LEREBOURS, MD · Centre René Huguenin
-
Jean-Yves PIERGA, MD · Institut Curie
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- FACTORIAL
Eligibility
- Min Age
- 18 Years
- Sex
- FEMALE
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2009-01-31
- Primary Completion
- 2010-12-31
- Completion
- 2011-12-31
Countries
- France
Study Locations
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