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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Gustave Roussy, Cancer Campus, Grand Paris
• Collaborator: Institut Curie
• Treatments: Docetaxel

Criteria

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