Preoperative treatment of breast cancer with a combination of epirubicin, docetaxel and bevacizumab. A translational trial on molecular markers and functional imaging to predict response early - PROMIX

Conditions: 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: 9.1Level: LLTClassification code 10006200Term: Breast cancer stage II
MedDRA version: 9.1Level: LLTClassification code 10006201Term: Breast cancer stage III
MedDRA version: 9.1Level: LLTClassification code 10021974Term: Inflammatory breast cancer

Registration Number: EUCTR2007-005858-23-SE

Lead Sponsor: PROMIX Trial Group

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: Female

Target Recruitment: 200

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

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.