Addition of Carboplatin to Neoadjuvant Therapy for Triple-negative and HER2-positive Early Breast Cancer

Exclusion Criteria

• •1. Prior chemotherapy for any malignancy.
• •2. Prior radiation therapy for breast cancer.
• •3. Pregnant or lactating patients. Patients of childbearing potential must implement adequate non-hormonal contraceptive measures (barrier methods, intrauterine contraceptive devices, sterilization) during study treatment.
• •4. Inadequate general condition (not fit for anthracycline-taxane-targeted agents-based chemotherapy).
• •5. Previous malignant disease being disease-free for less than 5 years (except CIS of the cervix and non-melanomatous skin cancer).
• •6. Known or suspected congestive heart failure (\>NYHA I) and / or coronary heart disease, angina pectoris requiring antianginal medication, previous history of myocardial infarction, evidence of transmural infarction on ECG, uncontrolled or poorly controlled arterial hypertension (i.e. BP \>160 / 90 mm Hg under treatment with two antihypertensive drugs), rhythm abnormalities requiring permanent treatment, clinically significant valvular heart disease.
• •7. Previous thromboembolic event (except when thrombophily screening is negative).
• •8. Known hemorrhagic diathesis or coagulopathy with increased bleeding risk.
• •9. History of significant neurological or psychiatric disorders including psychotic disorders, dementia or seizures that would prohibit the understanding and giving of informed consent
• •10. Pre-existing motor or sensory neuropathy of a severity ≥ grade 2 by NCI-CTC criteria v 4.0.
• •11. Currently active infection.
• •12. Active peptic ulcer.
• •13. Incomplete wound healing or unhealed bone fracture.
• •14. Disease significantly affecting gastrointestinal function, e.g. malabsorption syndrome, resection of the stomach or small bowel, ulcerative colitis.
• •15. History of abdominal fistula or any grade 4 non-gastrointestinal fistula, gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment.
• •16. Severe pulmonary condition / illness.
• •17. Major surgery within the last 28 days or anticipation of the need for major surgery during study treatment with bevacizumab. Minor surgeries including insertion of an indwelling catheter or sentinel lymph node biopsy within 24 h prior to chemotherapy.
• •18. Definite contraindications for the use of corticosteroids except inhalative corticoids.
• •19. Known hypersensitivity reaction to one of the compounds or incorporated substances used in this protocol;
• •20. Concurrent treatment with:
• •* chronic corticosteroids unless initiated \> 6 months prior to study entry and at low dose (≤ 10 mg methylprednisolone or equivalent).
• •* sex hormones. Prior treatment must be stopped before study entry.
• •* virostatic agents like sorivudine or analogs like brivudine, concurrent treatment with aminoglycosides.
• •* anticoagulants: heparin, warfarin as well as acetylic acid (e.g. Aspirin®) at a dose of \> 325 mg/day or clopidogrel at a dose of \> 75 mg/day.
• •* other experimental drugs or any other anti-cancer therapy.
• •* drugs recognized as being strong inhibitors or inducers of the isoenzyme CYP3A, e.g. Rifabutin, Rifampicin, Clarithromycin, Ketoconazole, Itraconazole, Ritonavir, Telithromycin, Erythromycin, Verapamil, Diltiazem within the last 5 days or the expected need for these treatments during study participation.
• •21. Participation in another clinical trial with any investigational, not marketed drug within 30 days prior to study entry.
• •22. Male patients.