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

Breast Cancer Clinical Trial

— REMAGUS04  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01180335
• Other study ID #: CSET1376
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2010
• Last updated: March 15, 2012
• Start date: January 2009
• Est. completion date: December 2011

Study information

• Verified date: August 2010
• Source: Gustave Roussy, Cancer Campus, Grand Paris
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 303
• Est. completion date: December 2011
• Est. primary completion date: December 2010
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Chemotherapy
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.

Locations

Country	Name	City	State
France	Institut Gustave Roussy	Villejuif

Sponsors (3)

Lead Sponsor	Collaborator
Gustave Roussy, Cancer Campus, Grand Paris	Centre Rene Huguenin, Institut Curie

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Complete response rate based on the histology		Tumoral assessment at 4 and 8 cycles	No