Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer

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

Detailed Description
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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.

Official Title
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Randomized Trial Comparing Standard Neoadjuvant Chemotherapy to Genomic Driven Chemotherapy Regimen in Patients With Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Chemotherapy
* Drug: Genomic driven chemotherapy


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Chemotherapy<br>4 cycles FEC followed by 4 cycles docetaxel | Drug: Chemotherapy<br>* 4 cycles FEC followed by 4 cycles docetaxel<br>|
| Experimental: Genomic driven chemotherapy<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete response rate based on the histology |  | Tumoral assessment at 4 and 8 cycles | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Genomic driven chemotherapy