Status:
COMPLETED
Experience of the Patient Treated With Trastuzumab (Herceptin ®) as Adjuvant for Breast Cancer
Lead Sponsor:
Centre Francois Baclesse
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
Many studies have been devoted to the quality of life of patients during adjuvant chemotherapy for breast cancer by highlighting fatigue, psychological distress and impact on the immediate environment...
Eligibility Criteria
Inclusion
- Women aged over 18
- Invasive breast carcinoma confirmed histologically
- Non-metastatic cancer
- Surgery of the primary tumor performed (mastectomy or lumpectomy) and associated with an audit axillary (sentinel node and / or axillary dissection)
- Patient should receive their last course of adjuvant chemotherapy (3 FEC and 3 Taxotere)
- Patients not receiving the third course of Taxotere because of toxicities may be included in the fifth course of chemotherapy is the second of Taxotere
- For the group Herceptin ®: HER2 overexpression without contraindication to treatment administration
- For the control group: no indication for Herceptin ®
- Radiation therapy and / or adjuvant hormonal therapy allowed
- Free and informed consent signed
Exclusion
- Women under 18 or over 60 years
- Histology other than adenocarcinoma
- Metastatic Breast Cancer
- Chemotherapy neoadjuvant
- Surgery of the primary tumor unrealized
- Lack of adjuvant chemotherapy with Taxotere 3 FEC and 3
- Patients with a history of malignancy within 5 years, outside of a basal cell cancer or cancer of the cervix treated and cured
- Patient under guardianship or unable to give informed consent,
- Pregnant or lactating
- Patient unable to undergo a medical for geographical, social or psychopathological
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2015
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT01400438
Start Date
July 1 2011
End Date
September 1 2015
Last Update
July 21 2016
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Centre François BACLESSE
Caen, Calvados, France, 14076