Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer
REMAGUS04
Randomized Trial Comparing Standard Neoadjuvant Chemotherapy to Genomic Driven Chemotherapy Regimen in Patients With Breast Cancer
1 other identifier
interventional
303
1 country
1
Brief Summary
This randomized trial is comparing a standard neoadjuvant chemotherapy with a genomic driven chemotherapy in patients with breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3 breast-cancer
Started Jan 2009
Shorter than P25 for phase_3 breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2009
CompletedFirst Submitted
Initial submission to the registry
August 5, 2010
CompletedFirst Posted
Study publicly available on registry
August 12, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2011
CompletedMarch 16, 2012
August 1, 2010
1.9 years
August 5, 2010
March 15, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Complete response rate based on the histology
Tumoral assessment at 4 and 8 cycles
Study Arms (2)
Chemotherapy
ACTIVE COMPARATOR4 cycles FEC followed by 4 cycles docetaxel
Genomic driven chemotherapy
EXPERIMENTALHigh 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.
Interventions
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 Criteria
You may qualify if:
- 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%
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gustave Roussy, Cancer Campus, Grand Parislead
- Institut Curiecollaborator
Study Sites (1)
Institut Gustave Roussy
Villejuif, 94800, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florence LEREBOURS, MD
Centre René Huguenin
- PRINCIPAL INVESTIGATOR
Jean-Yves PIERGA, MD
Institut Curie
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
August 5, 2010
First Posted
August 12, 2010
Study Start
January 1, 2009
Primary Completion
December 1, 2010
Study Completion
December 1, 2011
Last Updated
March 16, 2012
Record last verified: 2010-08