- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01180335
Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer (REMAGUS04)
March 15, 2012 updated by: Gustave Roussy, Cancer Campus, Grand Paris
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
303
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Villejuif, France, 94800
- Institut Gustave Roussy
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Factorial Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Chemotherapy
4 cycles FEC followed by 4 cycles docetaxel
|
4 cycles FEC followed by 4 cycles docetaxel
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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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complete response rate based on the histology
Time Frame: Tumoral assessment at 4 and 8 cycles
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Tumoral assessment at 4 and 8 cycles
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Florence LEREBOURS, MD, Centre René Huguenin
- Principal Investigator: Jean-Yves PIERGA, MD, Institut Curie
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2009
Primary Completion (Actual)
December 1, 2010
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
August 5, 2010
First Submitted That Met QC Criteria
August 10, 2010
First Posted (Estimate)
August 12, 2010
Study Record Updates
Last Update Posted (Estimate)
March 16, 2012
Last Update Submitted That Met QC Criteria
March 15, 2012
Last Verified
August 1, 2010
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSET1376
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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