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

Gustave Roussy, Cancer Campus, Grand Paris303 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

303

Conditions

Breast Cancer

Interventions

ChemotherapyDRUG

4 cycles FEC followed by 4 cycles docetaxel

Genomic driven chemotherapyDRUG

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

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

Institut Gustave Roussy

Villejuif, France

Outcomes

Primary Outcomes

Complete response rate based on the histology

Time frame: Tumoral assessment at 4 and 8 cycles

Data from ClinicalTrials.gov

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