Standard Neoadjuvant Chemotherapy Versus Genomic Driven Chemotherapy in Patients With Breast Cancer (REMAGUS04)

Gustave Roussy

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Chemotherapy; Drug: Genomic driven chemotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01180335

CSET1376

Details and patient eligibility

About

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

Full 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.

Enrollment: 303 patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

303 participants in 2 patient groups

Chemotherapy

Active Comparator group

Description:

4 cycles FEC followed by 4 cycles docetaxel

Treatment:

Drug: Chemotherapy

Genomic driven chemotherapy

Experimental group

Description:

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.

Treatment:

Drug: Genomic driven chemotherapy