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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Genomic driven chemotherapy; Drug: Chemotherapy

• Registration Number: NCT01180335
• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris

Brief Summary

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

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 Timeline

• Study Start: 2009-01
• Status Verified: 2010-08
• Study First Submitted: 2010-08-05
• Study First Submitted QC: 2010-08-10
• Study First Posted: 2010-08-12
• Primary Completion: 2010-12
• Study Completion: 2011-12
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 303

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Genomic driven chemotherapy	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.
Chemotherapy	Chemotherapy	4 cycles FEC followed by 4 cycles docetaxel

Primary Outcome Measures

Name	Time	Method
Complete response rate based on the histology	Tumoral assessment at 4 and 8 cycles

Trial Locations

Locations (1)

Institut Gustave Roussy; 🇫🇷 Villejuif, France