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


Phase 3
18 Years
N/A
Not Enrolling
Female
Breast Cancer

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Complete response rate based on the histology

Outcome Time Frame:

Tumoral assessment at 4 and 8 cycles

Safety Issue:

No

Principal Investigator

Florence LEREBOURS, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Centre René Huguenin

Authority:

France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Study ID:

CSET1376

NCT ID:

NCT01180335

Start Date:

January 2009

Completion Date:

December 2011

Related Keywords:

  • Breast Cancer
  • Genomic driven chemotherapy
  • Breast Neoplasms

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