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

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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01180335

Acronym

REMAGUS04

Enrollment

303

Registered

2010-08-12

Start date

2009-01-01

Completion date

2011-12-01

Last updated

2026-08-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Genomic driven chemotherapy

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.

Interventions

DRUGChemotherapy

4 cycles FEC followed by 4 cycles docetaxel

DRUGGenomic 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.

Study design

Allocation

RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Complete response rate based on the histology	Tumoral assessment at 4 and 8 cycles

Countries

France

Contacts

PRINCIPAL_INVESTIGATORFlorence LEREBOURS, MD

Centre René Huguenin

PRINCIPAL_INVESTIGATORJean-Yves PIERGA, MD

Institut Curie

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 18, 2026