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

NCT ID: NCT01180335

Last Updated: 2012-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 303 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2011-12-31

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Chemotherapy

4 cycles FEC followed by 4 cycles docetaxel

Group Type: ACTIVE_COMPARATOR

Chemotherapy

Intervention Type: DRUG

4 cycles FEC followed by 4 cycles docetaxel

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.

Group Type: EXPERIMENTAL

Genomic driven chemotherapy

Intervention Type: DRUG

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.

Interventions

Chemotherapy

4 cycles FEC followed by 4 cycles docetaxel

Intervention Type: DRUG

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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Institut Curie

OTHER

Sponsor Role: collaborator

Gustave Roussy, Cancer Campus, Grand Paris

OTHER

Sponsor Role: lead

Responsible Party

G.I.E. REMAGUS

Principal Investigators

Florence LEREBOURS, MD

Role: PRINCIPAL_INVESTIGATOR

Centre René Huguenin

Jean-Yves PIERGA, MD

Role: PRINCIPAL_INVESTIGATOR

Institut Curie

Locations

Institut Gustave Roussy

Villejuif, , France

Countries

France

Other Identifiers

CSET1376

Identifier Type: -

Identifier Source: org_study_id