Status:
COMPLETED
Treatment Decision Impact of OncotypeDX™ in HR+, N- Breast Cancer Patients
Lead Sponsor:
Genomic Health®, Inc.
Collaborating Sponsors:
Registrat-Mapi
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Primary objective: Determine the impact of the Oncotype DX Recurrence Score (RS) on the treatment recommendation made (administration of chemotherapy or not, in addition to hormonotherapy) in a HR+, ...
Eligibility Criteria
Inclusion
- Patients \> 18 years old.
- Pre- or post- menopausal women with breast adenocarcinoma, confirmed by a pathologist and who underwent surgery, with a maximum of 4 weeks between surgery and the 2nd therapeutic decision with Oncotype DX.
- HR positive (at least ER+) breast cancer patients (defined by a threshold of 10% of the cells IHC + without N- or pN1(mi), Her2 - (IHC0, 1, 2+ or FISH -)
- Patients must be eligible to receive adjuvant chemotherapy as defined by a good Karnofsky index, no hematological, cardiological or hepatic contraindications nor any impeding comorbidity.
- Patients must have given a written informed consent.
Exclusion
- T3 or T4, HR-, N+ (except pN1 (mi) (sn), Her2+ (IHC 3+ or Fish+) patients.
- Metastatic patients.
- Patients who cannot give an informed consent.
- Patients who cannot receive chemotherapy.
- Patient who participated in another clinical trial and is still in the exclusion period of any other trial.
- Mentally disabled patient who has no legal responsibility for herself.
Key Trial Info
Start Date :
January 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT01446185
Start Date
January 1 2011
End Date
May 1 2012
Last Update
April 18 2013
Active Locations (6)
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1
CHRU Besançon
Besançon, France, 25030
2
Centre Jean Perrin
Clermont-Ferrand, France, 63011
3
Centre Val d'Aurelle
Montpellier, France, 34298
4
Centre Azuréen de Cancérologie
Mougins, France, 6250