Phase
Condition
Breast Cancer
Treatment
N/AClinical Study ID
Ages > 18 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
1.Written informed consent for all study procedures according to local regulatoryrequirements prior to beginning specific protocol procedures.
2.Complete baseline documentation must be submitted via Medcodes® and approved by GBGForschungs GmbH.
3.Unilateral or bilateral primary carcinoma of the breast, confirmed histologically bycore biopsy. Fine-needle aspiration is not sufficient. Incisional biopsy is notallowed. In case of bilateral cancer, the investigator has to decide prospectivelywhich side will be evaluated for the primary endpoint.
4.Tumor lesion in the breast with a palpable size of ≥ 2 cm or a sonographical size of ≥ 1 cm in maximum diameter. The lesion has to be measurable in two dimensions,preferably by sonography. In case of inflammatory disease, the extent of inflammationcan be used as measurable lesion.
5.Patients should be in the following stages of disease: cT2 - cT4a-d or cT1c and cN+or pNSLN+
6.In patients with multifocal or multicentric breast cancer, the largest lesion shouldbe measured.
7.Centrally confirmed ER/PR/HER-2 and Ki-67 status detected on core biopsy. ER/PRpositive is defined as >1% stained cells and HER2-positive is defined as HercepTestIHC 3+ or FISH ratio ≥ 2.2. Formalin-fixed, paraffin-embedded (FFPE) breast tissuefrom core biopsy has therefore to be sent to the Dept. of Pathology at the Charité,Berlin prior to randomization.
8.Age ≥ 18 years.
9.Karnofsky Performance status index ≥ 80%.
10.Normal cardiac function must be confirmed by ECG and cardiac ultrasound (LVEF orshortening fraction) within 3 months prior to randomization. LVEF must be above 55%.
11.Laboratory requirements: Hematology
Absolute neutrophil count (ANC) ≥ 2.0 x 109 / L and
Platelets ≥ 100 x 109 / L and
Hemoglobin ≥ 10 g/dL (≥ 6.2 mmol/L) Hepatic function
Total bilirubin < 1.5x UNL and
ASAT (SGOT) and ALAT (SGPT) ≤ 1.5x UNL and
Alkaline phosphatase ≤ 2.5x UNL. Renal function
Creatinine ≤ 175 µmol/L (2 mg/dL) < 1.5x UNL
Proteinuria: Urine dipstick for proteinuria < 2+. Patients discovered to have ≥ 2+proteinuria on dipstick urinalysis should undergo a 24-hour urine collection and mustdemonstrate ≤ 1 g of protein in 24 hours. If creatinine is between 140 - 175 umol/L (1.6-2.0 mg/dL), the creatinine clearance (calculated or measured) should be ≥ 45mL/min.
12.Negative pregnancy test (urine or serum) within 14 days prior to randomization forall women of childbearing potential.
13.Complete staging work-up within 3 months prior to randomization. All patients musthave bilateral mammography, breast ultrasound (≤ 21 days), breast MRI (optional),chest X-ray (PA and lateral), abdominal ultrasound or CT scan or MRI, and bone scandone. In case of positive bone scan, bone X-ray (or CT or MRI) is mandatory. Othertests may be performed as clinically indicated.
14.Patients must be available and compliant for central diagnostics, treatment andfollow-up.
Exclusion
Exclusion Criteria:
Prior chemotherapy for any malignancy.
Prior radiation therapy for breast cancer.
Pregnant or lactating patients. Patients of childbearing potential must implementadequate non-hormonal contraceptive measures (barrier methods, intrauterinecontraceptive devices, sterilization) during study treatment.
Inadequate general condition (not fit for anthracycline-taxane-targeted agents-basedchemotherapy).
Previous malignant disease being disease-free for less than 5 years (except CIS of thecervix and non-melanomatous skin cancer).
Known or suspected congestive heart failure (>NYHA I) and / or coronary heart disease,angina pectoris requiring antianginal medication, previous history of myocardialinfarction, evidence of transmural infarction on ECG, uncontrolled or poorlycontrolled arterial hypertension (i.e. BP >160 / 90 mm Hg under treatment with twoantihypertensive drugs), rhythm abnormalities requiring permanent treatment,clinically significant valvular heart disease.
Previous thromboembolic event (except when thrombophily screening is negative).
Known hemorrhagic diathesis or coagulopathy with increased bleeding risk.
History of significant neurological or psychiatric disorders including psychoticdisorders, dementia or seizures that would prohibit the understanding and giving ofinformed consent
Pre-existing motor or sensory neuropathy of a severity ≥ grade 2 by NCI-CTC criteria v 4.0.
Currently active infection.
Active peptic ulcer.
Incomplete wound healing or unhealed bone fracture.
Disease significantly affecting gastrointestinal function, e.g. malabsorptionsyndrome, resection of the stomach or small bowel, ulcerative colitis.
History of abdominal fistula or any grade 4 non-gastrointestinal fistula,gastrointestinal perforation or intra-abdominal abscess within 6 months of enrolment.
Severe pulmonary condition / illness.
Major surgery within the last 28 days or anticipation of the need for major surgeryduring study treatment with bevacizumab. Minor surgeries including insertion of anindwelling catheter or sentinel lymph node biopsy within 24 h prior to chemotherapy.
Definite contraindications for the use of corticosteroids except inhalativecorticoids.
Known hypersensitivity reaction to one of the compounds or incorporated substancesused in this protocol;
Concurrent treatment with:
chronic corticosteroids unless initiated > 6 months prior to study entry and atlow 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 treatmentwith aminoglycosides.
anticoagulants: heparin, warfarin as well as acetylic acid (e.g. Aspirin®) at adose 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 5days or the expected need for these treatments during study participation.
Participation in another clinical trial with any investigational, not marketed drugwithin 30 days prior to study entry.
Male patients.
Study Design
Study Description
Connect with a study center
Praxis Dr. Heinrich
Fürstenwalde, Brandenburg 15517
GermanySite Not Available
Praxis Dr. Heinrich
Fürstenwalde, Brandenburg 15517
GermanySite Not Available
Luisenkrankenhaus
Düsseldorf, Nordrhein-Westfalen 40235
GermanySite Not Available
Luisenkrankenhaus
Düsseldorf, Nordrhein-Westfalen 40235
GermanySite Not Available
NCT Heidelberg
Heidelberg,
GermanySite Not Available
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