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OpenTrials
Completed

NCT Number: NCT01180335

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

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

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Institut Gustave Roussy

Villejuif, 94800, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Chemotherapy

Drug

4 cycles FEC followed by 4 cycles docetaxel

Genomic driven chemotherapy

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.

Primary outcomes

  1. Complete response rate based on the histology

    Time frame: Tumoral assessment at 4 and 8 cycles

Sponsors and collaborators

Lead sponsor

Gustave Roussy, Cancer Campus, Grand Paris

Other

Collaborators

  • Institut Curie

Registry information

Official study title

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

Acronym: REMAGUS04

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Aug 12, 2010
Registry last updated
Mar 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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