A Translational Trial on Molecular Markers and Functional Imaging to Predict Response of Preoperative Treatment of Breast Cancer Early

• Status: Unknown status
• Trial end date: 2016-11-01
• Target enrollment: 0
• Participant gender: Female

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 epirubicin and docetaxel. Treatment evaluations are performed after the second, fourth and sixth cycle. In case of SD/PR after the second course, bevacizumab is added to the combination for the remaining four courses.

Besides standard response evaluation clinically and by mammography and ultrasound, several functional imaging techniques including MR, CT-PET and contrast-enhanced ultrasound are investigated. Fresh tumor tissue samples from the primary tumor are collected before start, after two courses and in connection with surgery. The aim of the trial is to detect biological factors and functional imaging techniques with the ability to predict response at an early stage of treatment.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Thomas Hatschek
• Treatments: Bevacizumab; Docetaxel; Epirubicin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.