Status:
UNKNOWN
Utilization of Genomic Signature as Decision-making for Adjuvant Treatment of Breast Cancer
Lead Sponsor:
Institut Paoli-Calmettes
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
NA
Brief Summary
Method: This multicentric prospective cohort is composed of patients with no metastatic breast cancer selected by tumor's genomic analysis and treated by chemotherapy with Anthracycline without Taxane...
Eligibility Criteria
Inclusion
- Women aged between 18 and 70
- Patient with life condition \< 2 (WHO scale)
- One-sided breast adenocarcinoma with a histological evidence (all type)
- Clinical presentation which allowed a complete surgery with healthy limits
- Absence of metastasis detectable at clinical examination or radiology
- Histological evidence for homolateral axillary ganglionic invasion, whatever is the number of node invaded (N \> 1)
- The beginning of the chemotherapy within 6 weeks following the primary surgery
Exclusion
- All metastatic affect
- Tumor classed \>= T4a: cutaneous invasion, deep adherence, inflammatory breast
- All chemotherapy, hormonotherapy or radiotherapy before surgery
- Tumoral residue not removed
- Any suspect clinic or radiologic lesion, in the contralateral breast, which is not controlled
- History of invasive neoplasm, mammary or other (except in situ carcinoma of cervix uteri and epithelioma)
Key Trial Info
Start Date :
April 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2015
Estimated Enrollment :
375 Patients enrolled
Trial Details
Trial ID
NCT00912080
Start Date
April 1 2007
End Date
May 1 2015
Last Update
March 20 2013
Active Locations (4)
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1
Centre Léon BERARD
Lyon, France
2
Institut PAOLI-CALMETTES
Marseille, France
3
Centre Antoine LACASSAGNE
Nice, France
4
Chu Font-Pre
Toulon, France