Patients diagnosed with breast cancer who are candidates for preoperative (neoadjuvant) chemotherapy due to 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. MedDRA version: 9.1 Level: LLT Classification code 10006200 Term: Breast cancer stage II MedDRA version: 9.1 Level: LLT Classificati
Conditions
Interventions
Trade Name: Avastin
Product Name: Avastin
Product Code: BEVACIZUMABUM
Pharmaceutical Form: Solution for infusion
Other descriptive name: BEVACIZUMABUM
Product Name: epirubicin
Pharmaceutical Form: In
Sponsors
PROMIX Trial Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Written informed consent 2. Female patients with breast cancer confirmed by histology. 3. Tumour and blood samples according to APPENDIX I available. 4. Age 18 years or older. Elderly patients in condition adequate for chemotherapy. 5. 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. 6. Adequate bone marrow, renal, hepatic and cardiac functions and no other uncontrolled medical or psychiatric disorders. 7. ECOG performance status 0-1. 8. Patients in child-bearing age with adequate contraception. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Distant metastases, including node metastases in the contralateral breast region and in the mediastine. 2. Other malignancy for the last two years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix. 3. Pregnancy or lactation. 4. Uncontrolled hypertension, heart, liver, kidney related or other medical or psychiatric disorders. 5. Recent history of thromboembolism and ongoing medication with full-dose anticoagulants. 6. Major surgery (including open biopsy), significant traumatic injury within 28 days prior to enrolment or anticipation of the need for major surgery during study treatment. 7. Minor surgery, including insertion of an indwelling catheter, within 24 hours prior to the first bevacizumab infusion. 8. History or evidence of inherited bleeding diathesis or coagulapathy with the risk of bleeding. 9. Non-healing wound, active peptic ulcer or bone fracture. 10. History of abdominal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment. 11. Pre-existing congestive heart failure (CHF) or symptoms according to NYHA classes II-IV, see APPENDIX II. 12. Peripheral neuropathy grade =2. 13. Known hypersensitivity to drugs formulated in polysorbate 80.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Evaluation of the sensitivity of defined diagnostic and biological procedures to detect response/non-response to neoadjuvant treatment at an early point among patients with breast cancer. ;Secondary Objective: 1. Identification of tumour characteristics and treatment-related changes of tumour characteristics predictive of long-term prognosis. 2. Comparison between the standard evaluation procedures mammography, conventional ultrasound and clinical examination and functional imaging techniques and biological procedures with emphasis on detection of response at an early point of treatment. 3. Studies on the addition of bevacizumab with regard to further improvement of response in tumours with stable (SD) or partial response (PR) and the impact of treatment on angiogenesis and local features of the tumour environment. 4. Evaluation of the feasibility and accuracy of sentinel node biopsy in breast cancer before and after preoperative chemotherapy. ;Primary end point(s): Objective response (OR) characterized by conventional radiological and functional imaging procedures and biological tumour markers at an early point of treatment with epirubicin + docetaxel and the effects of addition of bevacizumab as reflected by these procedures. Early functional and biological changes signalling pathological complete response (pCR). | — |
Countries
Sweden
Outcome results
None listed