Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer (REMAGUS04)

This study has been completed.
Sponsor:
Collaborators:
Centre Rene Huguenin
Institut Curie
Information provided by:
Gustave Roussy, Cancer Campus, Grand Paris
ClinicalTrials.gov Identifier:
NCT01180335
First received: August 5, 2010
Last updated: March 15, 2012
Last verified: August 2010

August 5, 2010
March 15, 2012
January 2009
December 2010   (final data collection date for primary outcome measure)
Complete response rate based on the histology [ Time Frame: Tumoral assessment at 4 and 8 cycles ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01180335 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer
Randomized Trial Comparing Standard Neoadjuvant Chemotherapy to Genomic Driven Chemotherapy Regimen in Patients With Breast Cancer

This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with breast cancer.

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 4FEC followed by 4 docetaxel (standard arm) or by a genomic-driven regimen (experiemental arm). In the experimental arm, patients with 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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Breast Cancer
  • Drug: Chemotherapy
    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.
  • Active Comparator: Chemotherapy
    4 cycles FEC followed by 4 cycles docetaxel
    Intervention: Drug: Chemotherapy
  • Experimental: 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.
    Intervention: Drug: Genomic driven chemotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
303
December 2011
December 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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 Criteria:

  • 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
Female
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01180335
CSET1376
Yes
ANDRE Fabrice, G.I.E. REMAGUS
Gustave Roussy, Cancer Campus, Grand Paris
  • Centre Rene Huguenin
  • Institut Curie
Principal Investigator: Florence LEREBOURS, MD Centre René Huguenin
Principal Investigator: Jean-Yves PIERGA, MD Institut Curie
Gustave Roussy, Cancer Campus, Grand Paris
August 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP