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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:
Institut Gustave Roussy
ClinicalTrials.gov Identifier:
NCT01180335
First received: August 5, 2010
Last updated: March 15, 2012
Last verified: August 2010
History of Changes
  Purpose

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


Condition Intervention Phase
Breast Cancer
 Drug: Chemotherapy
Drug: Genomic driven chemotherapy
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Randomized Trial Comparing Standard Neoadjuvant Chemotherapy to Genomic Driven Chemotherapy Regimen in Patients With Breast Cancer

Resource links provided by NLM:

Drug Information available for: Docetaxel
U.S. FDA Resources

Further study details as provided by Institut Gustave Roussy:

Primary Outcome Measures:
  • Complete response rate based on the histology [ Time Frame: Tumoral assessment at 4 and 8 cycles ] [ Designated as safety issue: No ]

Enrollment: 303
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Chemotherapy
4 cycles FEC followed by 4 cycles docetaxel
 Drug: Chemotherapy
4 cycles FEC followed by 4 cycles docetaxel
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.
 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.

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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01180335

Locations
France
Institut Gustave Roussy
Villejuif, France, 94800
Sponsors and Collaborators
Institut Gustave Roussy
Centre Rene Huguenin
Institut Curie
Investigators
Principal Investigator: Florence LEREBOURS, MD Centre René Huguenin
Principal Investigator: Jean-Yves PIERGA, MD Institut Curie
  More Information

No publications provided

Responsible Party: ANDRE Fabrice, G.I.E. REMAGUS
ClinicalTrials.gov Identifier: NCT01180335     History of Changes
Other Study ID Numbers: CSET1376
Study First Received: August 5, 2010
Last Updated: March 15, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Keywords provided by Institut Gustave Roussy:
Genomic driven chemotherapy

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 22, 2013