Status:
COMPLETED
Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer
Lead Sponsor:
Gustave Roussy, Cancer Campus, Grand Paris
Collaborating Sponsors:
Institut Curie
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE3
Brief Summary
This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with breast cancer.
Detailed Description
After a core biopsy, each tumor is profiled using Affymetrix U133plus2 gene expression array. DLD30 score (Hess, JCO, 2006) and TOP2A expression are quantified. Patients are then either treated with 4...
Eligibility Criteria
Inclusion
- Invasive breast cancer not eligible for conservative surgery
- Her2 negative
- Amount of tumor cells \>30% on HES slides
- RIN\>6 and amount of RNA\>1 ug
- No metastases
- Subject, age \> 18 years and \<65 years old
- Signed written informed consent
- PS 0-1
- No previous treatment for breast cancer
- Adequate organ function
- FEVG \>50%
Exclusion
- In situ carcinoma
- Multifocal cancers
- Her2+
- Presence of metastasis
- Genomic testing not feasible because of tumor cells \<30%, RIN\<6, insufficient amount of RNA
- Organ dysfunction that contraindicates chemotherapy
Key Trial Info
Start Date :
January 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
303 Patients enrolled
Trial Details
Trial ID
NCT01180335
Start Date
January 1 2009
End Date
December 1 2011
Last Update
March 16 2012
Active Locations (1)
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1
Institut Gustave Roussy
Villejuif, France, 94800