Status:
UNKNOWN
A Translational Trial on Molecular Markers and Functional Imaging to Predict Response of Preoperative Treatment of Breast Cancer Early
Lead Sponsor:
Thomas Hatschek
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Patients with localized primary breast cancer including inflammatory breast cancer suitable for primary medical treatment and/or regional lymph node metastases receive six cycles of chemotherapy with ...
Detailed Description
Primary endpoints: Objective response (OR) characterized by conventional radiological and functional imaging procedures and biological tumour markers at an early point of treatment with epirubicin + d...
Eligibility Criteria
Inclusion
- Written informed consent
- Female patients with breast cancer confirmed by histology.
- Tumour and blood samples according to APPENDIX I available.
- Age 18 years or older. Elderly patients in condition adequate for chemotherapy.
- Localized primary breast cancer including inflammatory breast cancer suitable for primary medical treatment and/or regional lymph node metastases including ipsilateral supraclavicular nodes with breast cancer diagnosis confirmed by histological examination with or without breast tumour lesions.
- Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders.
- ECOG performance status 0-1.
- Patients in child-bearing age with adequate contraception.
Exclusion
- Distant metastases, including node metastases in the contralateral breast region and in the mediastina.
- Other malignancy for the last two years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix.
- HER2-amplification verified by FISH analysis.
- Pregnancy or lactation.
- Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders.
- Recent history of thromboembolism and ongoing medication with full-dose anticoagulants.
- Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrollment or anticipation of the need for major surgery during study treatment.
- Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion.
- History or evidence of inherited bleeding diathesis or coagulopathy with the risk of bleeding.
- Non-healing wound, active peptic ulcer or bone fracture.
- History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrollment.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
151 Patients enrolled
Trial Details
Trial ID
NCT00957125
Start Date
September 1 2008
End Date
November 1 2016
Last Update
September 8 2016
Active Locations (6)
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1
Sahlgrenska University Hospital
Gothenburg, Sweden
2
Lund University Hospital
Lund, Sweden
3
Malmö General University Hospital
Malmo, Sweden
4
Karolinska University Hospital, Dept of Oncology
Stockholm, Sweden, SE-17176